HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Device Facts
| Record ID | K111999 |
|---|---|
| Device Name | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL |
| Applicant | Healgen Scientific,, LLC |
| Product Code | JIO · Hematology |
| Decision Date | Apr 17, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
Indications for Use
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Healgen 500 and 800 Urine Analyzers use reflectance photometry to quantitate analyte values from urine samples when using the Healgen 10 and 11 reagent test strips. The system is intended for prescription, in vitro diagnostic use only.
Device Story
Healgen Series Reagent Strips and Analyzers (Healgen 500/800) perform in vitro qualitative and semi-quantitative urinalysis. Strips contain color pads for specific analytes; color changes occur upon reaction with urine. Analyzers use reflectance photometry to measure color changes on strips (Healgen 10/11); Healgen 4 strips are visual-only. Used in clinical settings by professionals. Analyzers process samples, providing quantitative/semi-quantitative results to assist clinicians in diagnosing diabetes, metabolic/liver/kidney disorders, and UTIs. Results help rule out disease states or determine if microscopic analysis is required. Analyzers feature RS232C connectivity, 1000-result memory, and throughputs of 120 (Healgen 500) or 500 (Healgen 800) tests/hour.
Clinical Evidence
Clinical comparison studies conducted at 3 sites using Healgen 11 strips and predicate devices. Data collected via visual and instrumental (Healgen 500/800) reading. Results indicate comparable testing data between subject and predicate devices. Analytical performance characterized by cutoff limits, precision (within-run/within-day), and interference studies.
Technological Characteristics
Reflectance photometry; monochromatic light (420-950 nm). Reagent strips with colorimetric pads. Analyzers: Healgen 500 (120 tests/hr), Healgen 800 (500 tests/hr). Connectivity: RS 232C port. Power: AC 220V. Calibration via check strip. Software: Embedded firmware for signal processing and quantification.
Indications for Use
Indicated for qualitative and semi-quantitative urinalysis in patients to detect conditions including diabetes, metabolic abnormalities, liver disease, kidney dysfunction, and urinary tract infections. For prescription, in vitro diagnostic use.
Regulatory Classification
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Predicate Devices
- URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer (K040703)
Related Devices
- K111221 — MISSION U500 URINE ANALYZER · ACON Laboratories, Inc. · Jan 18, 2012
- K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS · Urit Medical Electronic Co., Ltd. · Sep 11, 2009
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k111999
B. Purpose for Submission:
New device
C. Measurand:
Urine leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ascorbic acid, ketone, bilirubin and glucose
D. Type of Test:
Qualitative and semi-quantitative urinalysis
E. Applicant:
Healgen Scientific LLC
F. Proprietary and Established Names:
Healgen Series Reagent Strips and Analyzers for Urinalysis
G. Regulatory Information:
1. Regulation section, classification, and product code:
| Classification Name | Product Code | Device Class | Regulation Number |
| --- | --- | --- | --- |
| Blood occult, colorimetric, in urine | JIO | II | 21 CFR 864.6550 |
| Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR 862.1340 |
| Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR 862.1785 |
| Urinary bilirubin and its conjugates (non-quantitative) test system | JJB | I | 21 CFR 862.1115 |
| Ketones (non-quantitative) test system | JIN | I | 21 CFR 862.1435 |
| Urinary protein or albumin (non-quantitative) test system | JIR | I | 21 CFR 862.1645 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR 862.1510 |
| Test, Urine Leukocyte | LJX | I | 21 CFR 864.7675 |
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| Urinary pH (non-quantitative) test system | CEN | I | 21 CFR 862.1550 |
| --- | --- | --- | --- |
| Ascorbic acid test system | JMA | I | 21 CFR 862.1095 |
| Refractometer for clinical use (specific gravity) | JRE | I | 21 CFR 862.2800 |
| Automated urinalysis system | KQO | I | 21 CFR 862.2900 |
2. Panel:
Clinical Chemistry, 75
Hematology, 82
H. Intended Use:
1. Intended use(s):
Refer to indications for use below.
2. Indication(s) for use:
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The Healgen 500 and 800 Urine Analyzers use reflectance photometry to quantitate analyte values from urine samples when using the Healgen 10 and 11 reagent test strips.
The system is intended for prescription, in vitro diagnostic use only.
3. Special conditions for use statement(s):
For in vitro diagnostic use only
For prescription use
4. Special instrument requirements:
Healgen 500 or 800 urine analyzer (if reading instrumentally) for Healgen 11 and Healgen 10 reagent strips only.
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I. Device Description:
Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnostic test devices that use reagents for qualitative and semi-quantitative urinalysis. The device is composed of several color pads aligned on a strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
Healgen Series Reagent Strip provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid, and Leukocytes in Urine and described in the table below.
| Reagent Strip | Test Analytes | Visual Read | Instrumentally Read |
| --- | --- | --- | --- |
| Healgen 11 | Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid, Leukocytes | Yes | Yes |
| Healgen 10 | Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes | Yes | Yes |
| Healgen 4 | Ketone, Protein, Glucose, pH | Yes | No |
J. Substantial Equivalence Information:
1. Predicate device name(s):
URISTK H Series Reagent Strips and Dirui H-50, H-100, H-500 Urine Analyzers for urinalysis.
2. Predicate 510(k) number(s):
k040703
3. Comparison with predicate:
| Comparison Table | | |
| --- | --- | --- |
| Item | New Device (k111999) | Predicate (k040703) |
| Intended Use | The Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. | Same |
| Specimen | Fresh Urine | Same |
| Test Principles | Established clinical chemistry methods | Same |
| Test Analytes | Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH, Ascorbic Acid | Same |
| Strip Incubation | Immerse the reagent area of the strip | Same |
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| Comparison Table | | |
| --- | --- | --- |
| Item | New Device (k111999) | Predicate (k040703) |
| Time | in the urine specimen, take it up quickly and immediately. | |
| Detection Method | Reflectance Photometry or Visual | Same |
| PC Port | Standard RS 232C | Same |
| Analyzer Operating Conditions | 0 to 40 degrees C; RH < 85% | Same |
| Wavelength | 420nm, 525nm, 560nm, 610nm, 660nm, 950nm | Same |
| Calibration | Using a Calibration Strip | Same |
| Strip Operation | Semi-automatic | Same |
| Power Source | AC 220V (±15%); 50 to 60Hz | Same |
| Line Leakage Current | <0.5 milliamperes in normal condition; <3.5 milliamperes in single fault condition | Same |
| Memory | 1000 test results | Same |
| Throughput | Healgen 500: 120 test/hour
Healgen 800: 500 test/hour | Dirui-50: 60 test/hour
Dirui-100: 120 test/hour
Dirui-500: 500 test/hour |
| Dimensions | 355mm×300mm×145mm | 324mm×327mm×185mm |
| Weight | 4 kg | About 5 kg |
| Display Dimensions | Healgen 500 240mm*64mm
Healgen 800 240mm*128mm | Dirui-50: 240mm*64mm
Dirui-100: 240mm*64mm
Dirui-500: 240mm*128mm |
## K. Standard/Guidance Document Referenced:
CLSI EP12-A2 – User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline.
CLSI EP9-A2 – Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.
ISO 2859-1:1999 - Sampling Procedures for Inspection by Attributes-Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.
## L. Test Principle:
**Urobilinogen** - This test is based on the Ehrlich reaction in which p-diethylamino benzaldehyde in conjunction with a color enhancer reacts with urobilinogen in a strongly acid medium to produce a pink-red color.
**Bilirubin** - The direct bilirubin and dichlorobenzene diazonium produce fuchsia azo dyes in a strongly acid medium.
**Ketone** - The acetoacetate and sodium nitroprusside cause a reaction in the alkaline medium, which produces a violet color.
**Blood** - Hemoglobin acts as a peroxidase. It can cause peroxidase to release neo-ecotypes oxide [O]. [O] oxidizes the indicator and causes the color change.
**Protein** - The test is based on the protein-error-of-indicators principle. An ion in the specific pH indicator attracted by cation on the protein molecule makes the indicator further ionized, which changes its color.
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Nitrite - Nitrite in the urine and aromatic amino sulphanilamide are diazotized to form a diazonium compound. The diazonium compound reacting with tetrahydro benzo(h) quinolin 3-phenol causes the color change.
Leukocytes - Granulocyte leukocytes in urine contain esterase that catalyzes the hydrolysis of the pyrrole amino acid ester to liberate 3-hydroxy-5-pheny pyrrole. This pyrrole reacting with diazonium forms a purple color.
Glucose - The glucose oxidized by glucose oxidase catalyzes the formation of glucuronic acid and peroxide hydrogen. Peroxide hydrogen releases neo-ecotypes oxide [O] under the function of peroxidase. [O] oxidizes iodide potassium, which causes the color change.
Specific Gravity - Electrolyte (M+X-) in the form of salt in urine reacts with poly methyl vinyl ether and maleic acid (-COOH), which is a weak acid ionic exchanger. The reaction produces hydrogenous ionogen, which reacts with a pH indicator that causes the color change.
pH - This test is based on a double indicator principle that gives a broad range of colors covering the entire urinary pH range.
Ascorbic Acid - Ascorbic acid, with 1,2-dihydroxy alkenes, under the alkaline condition, deoxidizes the blue 2,6-dichloroindophenolate into colorless N- (p-phenol)- 2,6-dichloro-p-amine phenol.
Healgen series Urine Analyzer adopts the principle of reflectance photometry to test the quantity of biochemical component according to the color change caused by getting the urinalysis strips react with the biochemical components in urine. The instrument uses four kinds of monochromatic light (wavelengths: 420, 525, 560, 610, 660, and 950 nm) to scan the reagent areas one after another, and the scanning system converts the optical signal to electric signal. After treatment, the reflection rate of the reagent area can be calculated according to the strength of the electric signal. The amount of the biochemical component in the urine sample can be calculated according to the reflective rate.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
The cut-off evaluation for all three formats (Healgen 4, 10, and 11) strips was evaluated using 20 replicates from each of 3 levels of urine controls (N=60). Control levels 1 and 2 represented the low and high samples. Level 3 controls was spiked sample with analyte concentration adjusted to around the cutoff value. The samples were blinded. Within-run precision was evaluated by testing 20 replicates on each of the three levels of urine controls using strips from each of 3 lots of strips. Within-day precision was evaluated by testing three levels of urine controls in duplicate, one a day, for 10 days using strips from 3 lots. Both reading methods (qualitative or semi-quantitative) were evaluated. Instrumental readings were performed on the Healgen 500 and Healgen 800. Testing was completed at three different point-of-care (POC) sites by six technicians at the POC sites. The technicians were provided with no other
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instructions other than the instrument manual and the test strip labeling. The results from the precision evaluation are summarized below:
Analyte Levels Tested
| Analyte | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- |
| Urobilinogen | 0.2 - 1.0 mg/dL | 4.0 - 8.0 mg/dL | 1.0 - 2.0 mg/dL |
| Bilirubin | Negative | 3.0 - 6.0 mg/dL (2+ - 3+) | 1.0 - 2.0 mg/dL (1+ ) |
| Ketone | Negative | 5.0 - 40 mg/dL (± - 2+) | 2.0 - 10 mg/dL (± ) |
| Blood | Negative | 80 - 200 Cells /μL (2+ - 3+) | 20 - 50Cells /μL (1+) |
| Protein | Negative | 30 - 300 mg/dL (1+ - 3+) | 10 - 80 mg/dL (± - 1+) |
| Nitrite | Negative | Positive | Positive |
| Leukocytes | Negative | 70 - 500 Cells /μL (1+ - 3+) | 20 - 120 Cells /μL (1+ - 2+) |
| Ascorbic Acid | 0 | 50 - 100 mg/dL | 12 - 25 mg/dL |
| Glucose | Negative | 270 - 1100 mg/dL (1+ - 3+) | 60 - 300 mg/dL (± - 1+) |
| Specific Gravity | 1.005 - 1.015 | 1.015 - 1.025 | 1.005 - 1.010 |
| pH | 5.0 - 6.5 | 7.0 - 8.5 | 5.5 - 6.5 |
Within-Run Study
Healgen 11 - Agreement of Visual Reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (100%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Specific Gravity | 58/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (96.7%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
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Healgen 11-Agreement of Reading by Healgen 500
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| pH | 59/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (98.3%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
Healgen 11 - Agreement of reading by Healgen 800
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 57/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (95%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
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| Nitrite | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| --- | --- | --- | --- | --- | --- | --- |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%)60 | (100%) | (100%) | (100%) |
| pH | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
Healgen 10 - Agreement of visual reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 57/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (100%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 60/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (95%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (100%) | (100%) | (100%) | (100%) |
| pH | 59/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (98.3%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
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Healgen 10-Agreement of Reading by Healgen 500
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Leukocyte | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 57/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (98.3%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
Healgen 10 - Agreement of reading by Healgen 800
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 57/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%)60 | (98.3%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
{9}
Healgen 4-Agreement of Visual Reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Ketone | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
Within-Day Study
Healgen 11 - Agreement of Visual Reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (100%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 57/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (100%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 60/60 | 57/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (95%) | (100%) | (100%) | (100%) |
{10}
Healgen 11 - Agreement of reading by Healgen 500
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (100%) | (100%) | (100%) | (100%) |
Healgen 11 - Agreement of reading by Healgen 800
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
{11}
| Blood | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| --- | --- | --- | --- | --- | --- | --- |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Ascorbic Acid | 58/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (96.7%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
Healgen 10 - Agreement of visual reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 57/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (96.7%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
{12}
Healgen 10 - Agreement of reading by Healgen 500
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 57/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (96.7%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (96.7%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 57/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (98.3%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
| Leukocytes | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (100%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Specific Gravity | 60/60 | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (96.7%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
Healgen 10 - Agreement of reading by Healgen 800
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Urobilinogen | 60/60 | 60/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (100%) | (98.3%) | (100%) | (100%) | (100%) |
| Bilirubin | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Ketone | 60/60 | 58/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (95%) | (100%) | (100%) | (100%) |
| Blood | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (95%) | (100%) | (100%) | (100%) |
| Nitrite | 60/60 | 57/60 | 57/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (95%) | (100%) | (100%) | (100%) |
{13}
| Leukocyte | 60/60 | 58/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| --- | --- | --- | --- | --- | --- | --- |
| | (100%) | (96.7%) | (98.3%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 57/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (95%) | (100%) | (100%) | (100%) | (100%) |
| Specific Gravity | 59/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (98.3%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 59/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (96.7%) | (100%) | (100%) | (100%) |
Healgen 4 - Agreement of visual reading
| Analyte | Exact match | | | Match within ±1 color block | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Ketone | 60/60 | 58/60 | 60/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (100%) | (100%) | (100%) | (100%) |
| Protein | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| Glucose | 60/60 | 59/60 | 59/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (98.3%) | (98.3%) | (100%) | (100%) | (100%) |
| pH | 60/60 | 58/60 | 58/60 | 60/60 | 60/60 | 60/60 |
| | (100%) | (96.7%) | (96.7%) | (100%) | (100%) | (100%) |
# b. Linearity/assay reportable range:
Linearity for the device was evaluated by visual reading and instrumental reading on the Healgen 500 and 800 by repeated testing of urine specimen containing known concentration of analytes. Negative samples and samples with pH or specific gravity at different levels were obtained by testing clinical samples with the predicate device. Those samples confirmed to be negative or expected were selected for the study. Positive samples were obtained by adding known amounts of analytes to negative control and confirming the expected value using the predicate device. Samples with specified values of pH or specific gravity were obtained by titration. Blind and random testing of samples was completed by two experimenters. Ten replicates for each strip from 3 manufacturing lots $(n = 30)$ were tested with each sample. The percentages of exact match and $\pm 1$ color block match of reported result to expected result were calculated and recorded as shown below:
| Analyte | Levels | Exact Match | | | ±1 Color Block Match | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Visual Read | Healgen 500 Read | Healgen 800 Read | Visual Read | Healgen 500 Read | Healgen 800 Read |
| Leukocytes (cells / μL) | Negative | 30 | 30 | 30 | | | |
| | 15 | 29 | 27 | 29 | 30 | 30 | 30 |
| | 70 | 29 | 27 | 29 | 30 | 30 | 30 |
| | 125 | 29 | 27 | 28 | 30 | 30 | 30 |
| | 500 | 30 | 30 | 29 | 30 | 30 | 30 |
| Nitrite | Negative | 30 | 30 | 30 | | | |
{14}
| | Positive 1 | 27 | 29 | 27 | 30 | 30 | 30 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Positive 2 | 30 | 30 | 29 | 30 | 30 | 30 |
| Urobilinogen (mg / dL) | 0.2 | 30 | 30 | 30 | 30 | 30 | 30 |
| | 1 | 29 | 28 | 30 | 30 | 30 | 30 |
| | 2 | 29 | 30 | 27 | 30 | 30 | 30 |
| | 4 | 27 | 28 | 28 | 30 | 30 | 30 |
| | 8 | 29 | 30 | 30 | 30 | 30 | 30 |
| Protein (mg / dL) | Negative | 30 | 30 | 30 | | | |
| | 10 | 27 | 28 | 29 | 30 | 30 | 30 |
| | 30 | 28 | 27 | 27 | 30 | 30 | 30 |
| | 100 | 30 | 29 | 29 | 30 | 30 | 30 |
| | 300 | 29 | 27 | 27 | 30 | 30 | 30 |
| | 2000 | 30 | 30 | 29 | 30 | 30 | 30 |
| pH | 5.0 | 29 | 30 | 30 | 30 | 30 | 30 |
| | 6.0 | 28 | 27 | 27 | 30 | 29 | 30 |
| | 6.5 | 27 | 30 | 29 | 30 | 30 | 30 |
| | 7.0 | 28 | 30 | 28 | 30 | 30 | 30 |
| | 7.5 | 29 | 30 | 26 | 30 | 30 | 30 |
| | 8.0 | 28 | 28 | 29 | 30 | 30 | 30 |
| | 8.5 | 30 | 29 | 30 | 30 | 30 | 30 |
| Blood (cells / μL) | Negative | 30 | 30 | 30 | | | |
| | 10 (NH)* | 30 | N/A | N/A | 30 | 30 | 30 |
| | 10 | 29 | 27 | 27 | 30 | 30 | 30 |
| | 25 | 27 | 30 | 27 | 30 | 30 | 30 |
| | 80 | 26 | 29 | 26 | 30 | 30 | 30 |
| | 200 | 29 | 30 | 29 | 30 | 30 | 30 |
| Specific Gravity | 1.000 | 30 | 30 | 30 | 30 | 30 | 30 |
| | 1.005 | 29 | 30 | 28 | 30 | 30 | 30 |
| | 1.010 | 27 | 29 | 28 | 30 | 30 | 30 |
| | 1.015 | 26 | 27 | 30 | 30 | 30 | 30 |
| | 1.020 | 28 | 29 | 30 | 30 | 30 | 30 |
| | 1.025 | 29 | 30 | 28 | 30 | 30 | 30 |
| | 1.030 | 30 | 30 | 30 | 30 | 30 | 30 |
| Ascorbic Acid (mg / dL) | 0 | 30 | 30 | 30 | | | |
| | 10 | 29 | 29 | 29 | 30 | 30 | 30 |
| | 25 | 28 | 29 | 27 | 29 | 30 | 30 |
| | 50 | 29 | 28 | 27 | 30 | 30 | 30 |
| | 100 | 30 | 30 | 29 | 30 | 30 | 30 |
| Ketone (mg / dL) | Negative | 30 | 30 | 30 | | | |
| | 5 | 29 | 30 | 28 | 30 | 30 | 30 |
| | 15 | 29 | 28 | 27 | 30 | 30 | 30 |
| | 40 | 27 | 29 | 28 | 30 | 30 | 30 |
| | 80 | 27 | 30 | 29 | 30 | 30 | 30 |
| | 160 | 29 | 29 | 30 | 30 | 30 | 30 |
| Bilirubin (mg / dL) | Negative | 30 | 30 | 30 | | | |
| | 1 | 30 | 29 | 27 | 30 | 30 | 30 |
| | 3 | 29 | 28 | 28 | 30 | 30 | 30 |
| | 6 | 30 | 30 | 30 | 30 | 30 | 30 |
| Glucose (mg / dL) | Negative | 30 | 30 | 30 | | | |
| | 90 | 28 | 29 | 29 | 30 | 30 | 30 |
| | 270 | 29 | 28 | 29 | 30 | 30 | 30 |
| | 550 | 27 | 28 | 27 | 30 | 30 | 30 |
| | 1100 | 27 | 29 | 30 | 30 | 30 | 30 |
{15}
The reportable ranges of Healgen strips for each analyte are listed in the table below.
| Analyte | Unit | Lab Assay Range | Reportable Range |
| --- | --- | --- | --- |
| Urobilinogen | (mg / dL) | 0.01 - 18.75 | 0.2 – 8 |
| Bilirubin | (mg / dL) | 0 - 18.8 | Negative – 6 |
| Ketone | (mg / dL) | 0.2 – 350 | Negative - 160 |
| Blood | cells / μL | 0 – 350 | Negative - 200 |
| Protein | (mg / dL) | 0.3 - 5000 | Negative - 2000 |
| Nitrite | (mg / dL) | 5.0 - 2000 | Negative - Positive |
| Leukocytes | cells / μL | 0 – 800 | Negative - 500 |
| Glucose | (mg / dL) | 0 - 5500 | Negative - 2000 |
| Specific Gravity | | 1.000 - 1.040 | 1.000 - 1.030 |
| pH | | 0 - 14.0 | 5.0 - 8.5 |
| Ascorbic Acid | (mg / dL) | 1 - 230 | Negative - 100 |
The specified reportable values of all the analytes are labeled above the corresponding blocks of the color charts on the strips inner labeling as shown below:
| Analyte | Unit | Levels (color Blocks) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative | Positive | | | | | |
| Leukocytes | cells / μL | Negative | 15 | 70 | 125 | 500 | | |
| Nitrite | | Negative | Positive 1 | Positive 2 | | | | |
| Urobilinogen | (mg / dL) | 0.2 | 1 | 2 | 4 | 8 | | |
| Protein | (mg / dL) | Negative | 10 | 30 | 100 | 300 | 2000 | |
| pH | | 5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 |
| Blood | cells / μL | Negative | 10(NH) | 10 | 25 | 80 | 200 | |
| Specific Gravity | | 1 | 1.005 | 1.01 | 1.015 | 1.02 | 1.025 | 1.03 |
| Ascorbic Acid | (mg / dL) | 0 | 10 | 25 | 50 | 100 | | |
| Ketone | (mg / dL) | Negative | 5 | 14 | 40 | 80 | 160 | |
| Bilirubin | (mg / dL) | Negative | 1 | 3 | 6 | | | |
| Glucose | (mg / dL) | Negative | 90 | 270 | 550 | 1100 | 2000 | |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The stability of the Healgen strips for urinalysis was evaluated using Healgen 11. This strip format has all 11 analytes that the strip series can test. Test results were read by the Healgen 500. Real-time stability data support the following manufacturer claim: "The strips can be stored in room temperature and closed package to 18
{16}
months from the manufacture date. If exposed to air with temperature of 15-30°C and relative humidity of 65-85%, the strips can be stored at least 12 hours.”
The manufacturer claims that the temperature of working environment for the Healgen 500 and 800 analyzers is 18-30°C with an optimum temperature range of 20-25°C and a relative humidity should be less than 80%.
No urinalysis controls are provided with the device. The sponsor recommends using commercially available positive and negative controls. Labeling also recommends the following:
- That two levels of commercially available controls are analyzed following laboratory policies and local, state and federal guidelines.
- Test commercially available positive and negative quality controls with each new lot, each new shipment of strips, and when a new bottle of reagent strips is opened.
- Water should not be used as a negative control.
d. Detection limit:
The cut-off evaluation was conducted using 20 replicates for each type of strip and each reading method. Negative and positive samples at different levels were confirmed by testing clinical samples with the predicate device. Positive samples were prepared by adding known amounts of analyte to negative samples. The cut-off for each analyte is defined as the value at which 50% of the test results are positive. The cut-off values for each strip format on all reading modes are shown in the tables below.
Visual results of Healgen 11
| Analyte | Cut-off (at least 50% Positive results) |
| --- | --- |
| Urobilinogen (mg / dL) | 2.5 |
| Bilirubin (mg / dL) | 0.80 |
| Ketone (mg / dL) | 0.60 |
| Blood (cells / μl) | 6 |
| Protein (mg / dL) | 7 |
| Nitrite (μg / dL) | 48 |
| Leukocytes (cells / μl) | 10 |
| Glucose (mg / dL) | 75 |
| Ascorbic Acid (mg / dL) | 7.5 |
| pH | 5.6 |
| Specific Gravity | 1.003 |
Results of Healgen 11 by Healgen 500
Target values of Leukocytes (cells / μL)
15
Cutoff concentration (cells / μL)
10
% Sensitivity
55
{17}
| 70 | 55 | 100 |
| --- | --- | --- |
| 125 | 105 | 100 |
| 500 | 350 | 100 |
| Target values of Nitrite (μg / dL) | Cutoff concentration (μg / dL) | % Sensitivity |
| Positive | 50 | 55 |
| Target values of Urobilinogen (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 60 |
| 2 | 1.6 | 100 |
| 4 | 3.4 | 100 |
| 8 | 6.2 | 100 |
| Target values of Protein (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 10 | 7.2 | 55 |
| 30 | 18 | 100 |
| 100 | 55 | 100 |
| 300 | 190 | 100 |
| 2000 | 550 | 100 |
| Target values of pH | Cutoff | % Sensitivity |
| 6 | 5.6 | 55 |
| 6.5 | 6.2 | 100 |
| 7 | 6.7 | 100 |
| 7.5 | 7.3 | 100 |
| 8 | 7.8 | 100 |
| 8.5 | 8.2 | 100 |
| Target values of Blood (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| 10 | 6.5 | 50 |
| 25 | 18 | 100 |
| 80 | 48 | 100 |
| 200 | 135 | 100 |
| Target values of Specific Gravity | Cutoff | % Sensitivity |
| 1.005 | 1.003 | 60 |
| 1.01 | 1.008 | 100 |
| 1.015 | 1.013 | 100 |
| 1.02 | 1.018 | 100 |
| 1.025 | 1.023 | 100 |
| 1.03 | 1.028 | 100 |
| Target values of Ascorbic Acid (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 10 | 6.5 | 60 |
| 25 | 18 | 100 |
| 50 | 35 | 100 |
| 100 | 75 | 100 |
| Target values of Ketone (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 5 | 3.5 | 50 |
| 14 | 9.5 | 100 |
| 40 | 26 | 100 |
| 80 | 60 | 100 |
| 160 | 125 | 100 |
| Target values of Bilirubin (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 55 |
{18}
19
| 3 | 2.2 | 100 |
| --- | --- | --- |
| 6 | 4.5 | 100 |
| Target values of Glucose (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 90 | 65 | 50 |
| 270 | 205 | 100 |
| 550 | 420 | 100 |
| 1100 | 850 | 100 |
| 2000 | 1450 | 100 |
Results of Healgen 11 by Healgen 800
| Target values of Leukocytes (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| --- | --- | --- |
| 15 | 10 | 55 |
| 70 | 55 | 100 |
| 125 | 105 | 100 |
| 500 | 350 | 100 |
| Target values of Nitrite (μg / dL) | Cutoff concentration (μg / dL) | % Sensitivity |
| Positive | 50 | 55 |
| Target values of Urobilinogen (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 60 |
| 2 | 1.6 | 100 |
| 4 | 3.4 | 100 |
| 8 | 6.2 | 100 |
| Target values of Protein (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 10 | 7.2 | 55 |
| 30 | 18 | 100 |
| 100 | 55 | 100 |
| 300 | 190 | 100 |
| 2000 | 550 | 100 |
| Target values of pH | Cutoff | % Sensitivity |
| 6 | 5.6 | 55 |
| 6.5 | 6.2 | 100 |
| 7 | 6.7 | 100 |
| 7.5 | 7.3 | 100 |
| 8 | 7.8 | 100 |
| 8.5 | 8.2 | 100 |
| Target values of Blood (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| 10 | 6.5 | 50 |
| 25 | 18 | 100 |
| 80 | 48 | 100 |
| 200 | 135 | 100 |
| Target values of Specific Gravity | Cutoff | % Sensitivity |
| 1.005 | 1.003 | 50 |
| 1.01 | 1.008 | 100 |
| 1.015 | 1.013 | 100 |
| 1.02 | 1.018 | 100 |
| 1.025 | 1.023 | 100 |
| 1.03 | 1.028 | 100 |
| Target values of Ascorbic | Cutoff concentration | % Sensitivity |
{19}
| Acid (mg / dL) | (mg / dL) | |
| --- | --- | --- |
| 10 | 6.5 | 60 |
| 25 | 18 | 100 |
| 50 | 35 | 100 |
| 100 | 75 | 100 |
| Target values of Ketone (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 5 | 3.5 | 50 |
| 14 | 9.5 | 100 |
| 40 | 26 | 100 |
| 80 | 60 | 100 |
| 160 | 125 | 100 |
| Target values of Bilirubin (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 55 |
| 3 | 2.2 | 100 |
| 6 | 4.5 | 100 |
| Target values of Glucose (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 90 | 65 | 50 |
| 270 | 205 | 100 |
| 550 | 420 | 100 |
| 1100 | 850 | 100 |
| 2000 | 1450 | 100 |
Visual results of Healgen 10
| Analyte | Cut-off (at least 50% Positive results) |
| --- | --- |
| Urobilinogen (mg / dL) | 2.5 |
| Bilirubin (mg / dL) | 0.80 |
| Ketone (mg / dL) | 0.60 |
| Blood (cells / μl) | 6 |
| Protein (mg / dL) | 7 |
| Nitrite (μg / dL) | 48 |
| Leukocytes (cells / μl) | 10 |
| Glucose (mg / dL) | 75 |
| pH | 5.6 |
| Specific Gravity | 1.003 |
Results of Healgen 10 by Healgen 500
| Target values of Leukocytes (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| --- | --- | --- |
| 15 | 10 | 55 |
| 70 | 55 | 100 |
| 125 | 105 | 100 |
| 500 | 350 | 100 |
| Target values of Nitrite (μg / dL) | Cutoff concentration (μg / dL) | % Sensitivity |
| Positive | 50 | 55 |
{20}
Results of Healgen 10 by Healgen 800
| Target values of Urobilinogen (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| --- | --- | --- |
| 1 | 0.7 | 60 |
| 2 | 1.6 | 100 |
| 4 | 3.4 | 100 |
| 8 | 6.2 | 100 |
| Target values of Protein (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 10 | 7.2 | 55 |
| 30 | 18 | 100 |
| 100 | 55 | 100 |
| 300 | 190 | 100 |
| 2000 | 550 | 100 |
| Target values of pH | Cutoff | % Sensitivity |
| 6 | 5.6 | 50 |
| 6.5 | 6.2 | 100 |
| 7 | 6.7 | 100 |
| 7.5 | 7.3 | 100 |
| 8 | 7.8 | 100 |
| 8.5 | 8.2 | 100 |
| Target values of Blood (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| 10 | 6.5 | 50 |
| 25 | 18 | 100 |
| 80 | 48 | 100 |
| 200 | 135 | 100 |
| Target values of Specific Gravity | Cutoff | % Sensitivity |
| 1.005 | 1.003 | 50 |
| 1.01 | 1.008 | 100 |
| 1.015 | 1.013 | 100 |
| 1.02 | 1.018 | 100 |
| 1.025 | 1.023 | 100 |
| 1.03 | 1.028 | 100 |
| Target values of Ketone (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 5 | 3.5 | 50 |
| 14 | 9.5 | 100 |
| 40 | 26 | 100 |
| 80 | 60 | 100 |
| 160 | 125 | 100 |
| Target values of Bilirubin (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 55 |
| 3 | 2.2 | 100 |
| 6 | 4.5 | 100 |
| Target values of Glucose (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 90 | 65 | 50 |
| 270 | 205 | 100 |
| 550 | 420 | 100 |
| 1100 | 850 | 100 |
| 2000 | 1450 | 100 |
{21}
| Target values of Leukocytes (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| --- | --- | --- |
| 15 | 10 | 55 |
| 70 | 55 | 100 |
| 125 | 105 | 100 |
| 500 | 350 | 100 |
| Target values of Nitrite (μg / dL) | Cutoff concentration (μg / dL) | % Sensitivity |
| Positive | 50 | 55 |
| Target values of Urobilinogen (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 60 |
| 2 | 1.6 | 100 |
| 4 | 3.4 | 100 |
| 8 | 6.2 | 100 |
| Target values of Protein (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 10 | 7.2 | 55 |
| 30 | 18 | 100 |
| 100 | 55 | 100 |
| 300 | 190 | 100 |
| 2000 | 550 | 100 |
| Target values of pH | Cutoff | % Sensitivity |
| 6 | 5.6 | 50 |
| 6.5 | 6.2 | 100 |
| 7 | 6.7 | 100 |
| 7.5 | 7.3 | 100 |
| 8 | 7.8 | 100 |
| 8.5 | 8.2 | 100 |
| Target values of Blood (cells / μL) | Cutoff concentration (cells / μL) | % Sensitivity |
| 10 | 6.5 | 60 |
| 25 | 18 | 100 |
| 80 | 48 | 100 |
| 200 | 135 | 100 |
| Target values of Specific Gravity | Cutoff | % Sensitivity |
| 1.005 | 1.003 | 55 |
| 1.01 | 1.008 | 100 |
| 1.015 | 1.013 | 100 |
| 1.02 | 1.018 | 100 |
| 1.025 | 1.023 | 100 |
| 1.03 | 1.028 | 100 |
| Target values of Ketone (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 5 | 3.5 | 50 |
| 14 | 9.5 | 100 |
| 40 | 26 | 100 |
| 80 | 60 | 100 |
| 160 | 125 | 100 |
| Target values of Bilirubin (mg / dL) | Cutoff concentration (mg / dL) | % Sensitivity |
| 1 | 0.7 | 55 |
| 3 | 2.2 | 100 |
| 6 | 4.5 | 100 |
| Target values of Glucose | Cutoff concentration | % Sensitivity |
{22}
| (mg / dL) | (mg / dL) | |
| --- | --- | --- |
| 90 | 65 | 50 |
| 270 | 205 | 100 |
| 550 | 420 | 100 |
| 1100 | 850 | 100 |
| 2000 | 1450 | 100 |
# e. Analytical specificity:
To evaluate interferences, known amounts of potential interfering substances were added to urine samples and tested using the Healgen 11 strip format. Five test strips from each of 3 lots were evaluated, in replicates of 15, for each interference test using the 3 reading modes (visual, Healgen 500, and Healgen 800). Analyte levels (positive, negative) were confirmed with the predicate method. Two levels of each analyte and 3 levels of interfering substance per analyte were evaluated in the study. Interference is defined by the sponsor as: a) For negative or lower level samples, with the presence of one potential interfering substance in a certain concentration, and no change of other conditions in the test system, if the reported results are $\geq 2$ color blocks different from the expected results (any positive result for nitrite), it is interference. And if $\pm 1$ color block match with the expected values (only negative for nitrite), it is non-interference. B) For positive or higher level samples, with the presence of one potential interfering substance in a certain concentration, and no change of other conditions in the test system, if the reported results $\geq 2$ color blocks different from the expected results (only negative for nitrite), it is an interference. And if $\pm 1$ color block match with the expected values (not negative for nitrite), it is non-interference.
Concentrations of the potentially interfering substances that will not have influence on the test results are shown below:
| Potential Interfering Substance | Concentration Not Affecting Test |
| --- | --- |
| Albumin | 800 mg/dL |
| Ascorbic Acid | 50 mg/dL |
| Hemoglobin | 50 mg/dL |
| Citric Acid | 50 mg/dL |
| Bilirubin | 3.0 mg/dL |
| Creatine | 8 mg/dL |
| Acetoacetate Acid | 1 mmol/L |
| Ammonium Chloride | 189 mg/dL |
| Calcium Chloride | 50 mg/dL |
| Creatinine | 800 mg/dL |
| Glucose | 2000 mg/dL |
| Glycine | 1000 mg/dL |
| KCL | 550 mg/dL |
| NaCl | 2800 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Acetate | 1200 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 0.26 mg/dL |
| Sodium Nitrite | 0.3 mg/dL |
| Sodium Phosphate | 16 mg/dL |
| Urobilinogen | 3.0 mg/dL |
| Urea | 3000 mg/dL |
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| Riboflavin | 100 mg/L |
| --- | --- |
| Theophylline | 100 mg/L |
| Phenolphthalein | 1200 mg/L |
| pH | 9.0 |
| Specific gravity | 1.030 |
| Glutathione | 200 mg/dL |
| Hypochlorite | 10 mg/L |
| Chlorine | 1 mg/dL |
| Peroxide | 1 mg/L |
| Atropine | 300 mg/L |
| Fructose | 5000 mg/dL |
| Lactose | 5000 mg/dL |
| Leucocytes | 800 cells/μL |
| Ketone | 200 mg/dL |
| Blood | 300 cells/μL |
| Mesna | 50 mg/dL |
The following limitations were observed and added to the strips instructions for use:
A high glucose concentration $(\geq 2000\mathrm{mg / dL})$ or a high specific gravity in urine may reduce the sensitivity of the test of leukocytes.
A high concentration of ascorbic acid $(\geq 50\mathrm{mg / dL})$ may cause a false negative result of bilirubin, blood, nitrite, and glucose.
Presence of oxidants (hypochlorite $\geq 50\mathrm{mg / L}$ , chlorine $\geq 5\mathrm{mg / dL}$ , and peroxide $\geq 5\mathrm{mg / L}$ ) will reduce the sensitivity of ascorbic acid in urine and lead to false positive results of blood in urine.
f. Assay cut-off:
Not applicable
# 2. Comparison studies:
# a. Method comparison with predicate device:
Comparison studies were performed at three different POC sites between the Healgen strips and the predicate method by visual and instrument readings. Urine samples were collected as indicated in the instructions for use and tested by 5 persons in each POC site (15 persons in total). The operators were blinded by masking the urine sample receptacles before being sent to them. Number of patient samples tested for each analyte was 100 (i.e. 33-34 patient samples tested at each of the 3 sites). The patient samples were collected so that at least 40 to $50\%$ of the samples were positive across the measuring range of each analyte, and at least $10\%$ of the samples were around the cutoff of each analyte. Results of the comparison study for the combined sites are shown in the table below.
Visual Read, Combined Sites 1-3 (n=100)
| Leukocytes (cells / μL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Negative | 15 | 70 | 125 | 500 |
| Proposed | Negative | 40 | 1 | 0 | 0 | 0 |
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| Device | 15 | 1 | 16 | 1 | 0 | 0 |
| --- | --- | --- | --- | --- | --- | --- |
| | 70 | 0 | 1 | 16 | 0 | 0 |
| | 125 | 0 | 2 | 1 | 9 | 0 |
| | 500 | 0 | 0 | 1 | 1 | 10 |
| Total | | 41 | 20 | 19 | 10 | 10 |
| % exact match | | 97.6 | 80 | 84.2 | 90 | 100 |
| % ±1 color block | | | 90 | 94.7 | 100 | 100 |
| Nitrite (μg / dL) | Predicate Device | | | |
| --- | --- | --- | --- | --- |
| | | Negative | Positive 1 | Positive 2 |
| Proposed Device | Negative | 57 | 1 | 0 |
| | Positive 1 | 0 | 26 | 1 |
| | Positive 2 | 0 | 0 | 15 |
| Total | | 57 | 27 | 16 |
| % exact match | | 100 | 96.3 | 93.6 |
| % ±1 color block | | | 100 | 100 |
| Urobilinogen (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0.2 | 1 | 2 | 4 | 8 |
| Proposed Device | 0.2 | 46 | 0 | 0 | 0 | 0 |
| | 1 | 1 | 16 | 1 | 1 | 0 |
| | 2 | 0 | 1 | 10 | 2 | 0 |
| | 4 | 0 | 1 | 1 | 9 | 1 |
| | 8 | 0 | 0 | 0 | 0 | 10 |
| Total | | 47 | 18 | 12 | 12 | 11 |
| % exact match | | 97.9 | 88.9 | 83.3 | 75 | 90.9 |
| % ±1 color block | | 100 | 94.4 | 100 | 91.7 | 100 |
| Protein (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 30 | 100 | 300 | 2000 |
| Proposed Device | NEG | 42 | 0 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 11 | 2 | 1 | 0 | 0 |
| | 30 | 0 | 1 | 11 | 1 | 0 | 0 |
| | 100 | 0 | 0 | 0 | 11 | 1 | 0 |
| | 300 | 0 | 0 | 0 | 0 | 11 | 0 |
| | 2000 | 0 | 0 | 0 | 0 | 0 | 8 |
| Total | | 42 | 12 | 13 | 13 | 12 | 8 |
| % exact match | | 100 | 91.7 | 84.6 | 84.6 | 91.7 | 100 |
| % ±1 color block | | | 100 | 100 | 92.3 | 100 | 100 |
| pH | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 |
| Proposed Device | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 6 | 0 | 14 | 0 | 0 | 0 | 0 | 0 |
| | 6.5 | 0 | 1 | 11 | 0 | 1 | 0 | 0 |
| | 7 | 0 | 0 | 1 | 11 | 2 | 0 | 0 |
| | 7.5 | 0 | 0 | 0 | 1 | 20 | 1 | 0 |
| | 8 | 0 | 0 | 0 | 0 | 1 | 22 | 0 |
| | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 7 | 15 | 12 | 12 | 24 | 23 | 7 |
| % exact match | | 100 | 93.3 | 91.7 | 91.7 | 83.3 | 95.7 | 100 |
| % ±1 color block | | 100 | 100 | 100 | 100 | 95.8 | 100 | 100 |
{25}
| Blood (cells / μL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10(NH) | 10 | 25 | 80 | 200 |
| Proposed Device | NEG | 40 | N/A | 0 | 0 | 0 | 0 |
| | 10(NH) | N/A | 10 | N/A | N/A | N/A | N/A |
| | 10 | 0 | N/A | 15 | 0 | 1 | 0 |
| | 25 | 0 | N/A | 2 | 10 | 1 | 0 |
| | 80 | 0 | N/A | 0 | 2 | 10 | 0 |
| | 200 | 0 | N/A | 0 | 0 | 0 | 9 |
| Total | | 40 | 10 | 17 | 12 | 12 | 9 |
| % exact match | | 100 | 100 | 88.2 | 83.3 | 83.3 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 | 100 |
| Ascorbic Acid (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0 | 10 | 25 | 50 | 100 |
| Proposed Device | 0 | 13 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 22 | 0 | 0 | 0 |
| | 25 | 0 | 2 | 21 | 0 | 0 |
| | 50 | 0 | 1 | 2 | 26 | 1 |
| | 100 | 0 | 0 | 1 | 2 | 9 |
| Total | | 13 | 25 | 24 | 28 | 10 |
| % exact match | | 100 | 88 | 87.5 | 92.8 | 90 |
| % ±1 color block | | | 96 | 95.8 | 100 | 100 |
| Specific Gravity | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1 | 1.005 | 1.01 | 1.015 | 1.02 | 1.025 | 1.03 |
| Proposed Device | 1 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 1.005 | 0 | 16 | 1 | 0 | 0 | 0 | 0 |
| | 1.01 | 0 | 1 | 18 | 1 | 1 | 0 | 0 |
| | 1.015 | 0 | 0 | 1 | 14 | 1 | 0 | 0 |
| | 1.02 | 0 | 0 | 0 | 2 | 11 | 1 | 0 |
| | 1.025 | 0 | 0 | 0 | 1 | 1 | 14 | 0 |
| | 1.03 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 9 | 17 | 20 | 18 | 14 | 15 | 7 |
| % exact match | | 100 | 94.1 | 90 | 77.8 | 78.6 | 93.3 | 100 |
| % ±1 color block | | 100 | 100 | 100 | 94.4 | 92.8 | 100 | 100 |
| Ketone (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 5 | 14 | 40 | 80 | 160 |
| Proposed Device | NEG | 46 | 0 | 0 | 0 | 0 | 0 |
| | 5 | 0 | 11 | 0 | 0 | 0 | 0 |
| | 14 | 0 | 0 | 14 | 0 | 0 | 0 |
| | 40 | 0 | 0 | 1 | 10 | 1 | 0 |
| | 80 | 0 | 0 | 0 | 1 | 9 | 0 |
| | 160 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 46 | 11 | 15 | 11 | 10 | 7 |
| % exact match | | 100 | 100 | 93.3 | 90.9 | 90 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 | 100 |
| Bilirubin (mg/dL) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | NEG | 1 | 3 | 6 |
| Proposed Device | NEG | 44 | 0 | 0 | 0 |
| | 1 | 0 | 23 | 0 | 0 |
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27
| | 3 | 0 | 2 | 20 | 0 |
| --- | --- | --- | --- | --- | --- |
| | 6 | 0 | 0 | 1 | 10 |
| Total | | 44 | 25 | 21 | 10 |
| % exact match | | 100 | 92 | 95.2 | 100 |
| % ±1 color block | | | 100 | 100 | 100 |
| Glucose (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 90 | 270 | 550 | 1100 | 2000 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 | 0 |
| | 90 | 0 | 12 | 0 | 0 | 0 | 0 |
| | 270 | 0 | 0 | 10 | 1 | 0 | 0 |
| | 550 | 0 | 0 | 1 | 10 | 0 | 0 |
| | 1100 | 0 | 0 | 1 | 1 | 12 | 0 |
| | 2000 | 0 | 0 | 0 | 0 | 0 | 12 |
| Total | | 40 | 12 | 12 | 12 | 12 | 12 |
| % exact match | | 100 | 100 | 83.3 | 83.3 | 100 | 100 |
| % ±1 color block | | | 100 | 91.7 | 100 | 100 | 100 |
Healgen 500 Read, Combined Sites 1-3 (n=100)
| Leukocytes (cells / μL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Negative | 15 | 70 | 125 | 500 |
| Proposed Device | NEG | 39 | 0 | 0 | 0 | 0 |
| | 15 | 2 | 18 | 1 | 0 | 0 |
| | 70 | 0 | 1 | 17 | 0 | 0 |
| | 125 | 0 | 1 | 1 | 9 | 0 |
| | 500 | 0 | 0 | 0 | 1 | 10 |
| Total | | 41 | 20 | 19 | 10 | 10 |
| % exact match | | 95.1 | 90 | 89.5 | 90 | 100 |
| % ±1 color block | | | 95 | 100 | 100 | 100 |
| Nitrite (μg / dL) | Predicate Device | | |
| --- | --- | --- | --- |
| | | Negative | Positive |
| Proposed Device | NEG | 57 | 1 |
| | positive | 0 | 42 |
| Total | | 57 | 43 |
| % exact match | | 100 | 97.7 |
| Urobilinogen (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0.2 | 1 | 2 | 4 | 8 |
| Proposed Device | 0.2 | 47 | 0 | 0 | 0 | 0 |
| | 1 | 0 | 16 | 0 | 0 | 0 |
| | 2 | 0 | 1 | 10 | 2 | 0 |
| | 4 | 0 | 0 | 1 | 10 | 0 |
| | 8 | 0 | 0 | 1 | 0 | 11 |
| Total | | 47 | 17 | 12 | 12 | 11 |
| % exact match | | 100 | 94.4 | 83.3 | 83.3 | 100 |
| % ±1 color block | | 100 | 100 | 91.7 | 100 | 100 |
| Protein (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 30 | 100 | 300 | 2000 |
| Proposed Device | NEG | 42 | 0 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 12 | 0 | 0 | 0 | 0 |
{27}
| | 30 | 0 | 0 | 11 | 1 | 0 | 0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 100 | 0 | 0 | 1 | 11 | 0 | 0 |
| | 300 | 0 | 0 | 1 | 1 | 11 | 0 |
| | 2000 | 0 | 0 | 0 | 0 | 0 | 8 |
| Total | | 42 | 12 | 13 | 13 | 12 | 8 |
| % exact match | | 100 | 100 | 84.6 | 84.6 | 100 | 100 |
| % ±1 color block | | | 100 | 92.3 | 100 | 100 | 100 |
| pH | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 |
| Proposed Device | 5 | 7 | 1 | 0 | 0 | 0 | 0 | 0 |
| | 6 | 0 | 13 | 0 | 0 | 0 | 0 | 0 |
| | 6.5 | 0 | 1 | 12 | 1 | 1 | 0 | 0 |
| | 7 | 0 | 0 | 0 | 11 | 2 | 0 | 0 |
| | 7.5 | 0 | 0 | 0 | 0 | 21 | 2 | 0 |
| | 8 | 0 | 0 | 0 | 0 | 0 | 21 | 0 |
| | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 7 | 15 | 12 | 12 | 24 | 23 | 7 |
| % exact match | | 100 | 86.7 | 100 | 91.7 | 87.5 | 91.3 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 95.8 | 100 | 100 |
| Blood (cells / μL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 25 | 80 | 200 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 25 | 1 | 1 | 0 |
| | 25 | 0 | 1 | 10 | 1 | 0 |
| | 80 | 0 | 1 | 1 | 10 | 0 |
| | 200 | 0 | 0 | 0 | 0 | 9 |
| Total | | 40 | 27 | 12 | 12 | 9 |
| % exact match | | 100 | 92.6 | 83.3 | 83.3 | 100 |
| % ±1 color block | | | 96.3 | 100 | 91.7 | 100 |
| Ascorbic Acid (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0 | 10 | 25 | 50 | 100 |
| Proposed Device | 0 | 13 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 24 | 0 | 0 | 0 |
| | 25 | 0 | 1 | 22 | 1 | 0 |
| | 50 | 0 | 0 | 1 | 26 | 0 |
| | 100 | 0 | 0 | 1 | 1 | 10 |
| Total | | 13 | 25 | 24 | 28 | 10 |
| % exact match | | 100 | 92 | 91.6 | 92.8 | 100 |
| % ±1 color block | | | 100 | 95.8 | 100 | 100 |
| Specific Gravity | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1 | 1.005 | 1.01 | 1.015 | 1.02 | 1.025 | 1.03 |
| Proposed Device | 1 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 1.005 | 0 | 17 | 0 | 0 | 0 | 0 | 0 |
| | 1.01 | 0 | 0 | 17 | 0 | 0 | 0 | 0 |
| | 1.015 | 0 | 0 | 2 | 14 | 1 | 0 | 0 |
| | 1.02 | 0 | 0 | 1 | 2 | 12 | 0 | 0 |
| | 1.025 | 0 | 0 | 0 | 2 | 1 | 15 | 0 |
| | 1.03 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 9 | 17 | 20 | 18 | 14 | 15 | 7 |
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| Ketone (mg/dL) | | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 5 | 14 | 40 | 80 | 160 |
| Proposed Device | NEG | 46 | 0 | 0 | 0 | 0 | 0 |
| | 5 | 0 | 10 | 0 | 0 | 0 | 0 |
| | 14 | 0 | 1 | 12 | 0 | 0 | 0 |
| | 40 | 0 | 0 | 2 | 10 | 0 | 0 |
| | 80 | 0 | 0 | 1 | 1 | 10 | 0 |
| | 160 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 46 | 11 | 15 | 11 | 10 | 7 |
| % exact match | | 100 | 90.9 | 80 | 90.9 | 100 | 100 |
| % ±1 color block | | | 100 | 93.3 | 100 | 100 | 100 |
| Bilirubin (mg/dL) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | NEG | 1 | 3 | 6 |
| Proposed Device | NEG | 44 | 0 | 0 | 0 |
| | 1 | 0 | 22 | 0 | 0 |
| | 3 | 0 | 2 | 19 | 0 |
| | 6 | 0 | 1 | 2 | 10 |
| Total | | 44 | 25 | 21 | 10 |
| % exact match | | 100 | 88 | 90.5 | 100 |
| % ±1 color block | | | 96 | 100 | 100 |
| Glucose (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 90 | 270 | 550 | 1100 | 2000 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 | 0 |
| | 90 | 0 | 12 | 0 | 0 | 0 | 0 |
| | 270 | 0 | 0 | 11 | 0 | 0 | 0 |
| | 550 | 0 | 0 | 1 | 10 | 0 | 0 |
| | 1100 | 0 | 0 | 0 | 2 | 12 | 0 |
| | 2000 | 0 | 0 | 0 | 0 | 0 | 12 |
| Total | | 40 | 12 | 12 | 12 | 12 | 12 |
| % exact match | | 100 | 100 | 91.7 | 83.3 | 100 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 | 100 |
Healgen 800 Read, Combined Sites 1-3 (n=100)
| Leukocytes (cells / μL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Negative | 15 | 70 | 125 | 500 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 |
| | 15 | 1 | 19 | 1 | 0 | 0 |
| | 70 | 0 | 1 | 17 | 0 | 0 |
| | 125 | 0 | 0 | 0 | 10 | 0 |
| | 500 | 0 | 0 | 1 | 0 | 10 |
| Total | | 41 | 20 | 19 | 10 | 10 |
| % exact match | | 97.6 | 95 | 89.5 | 100 | 100 |
| % ±1 color block | | | 100 | 94.7 | 100 | 100 |
| Nitrite (μg / dL) | Predicate Device | | |
| --- | --- | --- | --- |
| | | Negative | Positive |
| Proposed | NEG | 57 | 0 |
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| Device | positive | 0 | 43 |
| --- | --- | --- | --- |
| Total | | 57 | 43 |
| % exact match | | 100 | 100 |
| % ±1 color block | | | 100 |
| Urobilinogen (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0.2 | 1 | 2 | 4 | 8 |
| Proposed Device | 0.2 | 47 | 0 | 0 | 0 | 0 |
| | 1 | 0 | 15 | 1 | 1 | 0 |
| | 2 | 0 | 2 | 10 | 1 | 0 |
| | 4 | 0 | 0 | 1 | 10 | 0 |
| | 8 | 0 | 0 | 0 | 0 | 11 |
| Total | | 47 | 17 | 12 | 12 | 11 |
| % exact match | | 100 | 88.2 | 83.3 | 83.3 | 100 |
| % ±1 color block | | 100 | 100 | 100 | 91.7 | 100 |
| Protein (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 30 | 100 | 300 | 2000 |
| Proposed Device | NEG | 42 | 0 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 11 | 1 | 0 | 0 | 0 |
| | 30 | 0 | 1 | 12 | 1 | 0 | 0 |
| | 100 | 0 | 0 | 0 | 12 | 0 | 0 |
| | 300 | 0 | 0 | 0 | 0 | 12 | 0 |
| | 2000 | 0 | 0 | 0 | 0 | 0 | 8 |
| Total | | 42 | 12 | 13 | 13 | 12 | 8 |
| % exact match | | 100 | 91.7 | 92.3 | 92.3 | 100 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 | 100 |
| pH | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 |
| Proposed Device | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 6 | 0 | 15 | 0 | 0 | 0 | 0 | 0 |
| | 6.5 | 0 | 0 | 11 | 1 | 0 | 0 | 0 |
| | 7 | 0 | 0 | 1 | 10 | 1 | 0 | 0 |
| | 7.5 | 0 | 0 | 0 | 1 | 22 | 0 | 0 |
| | 8 | 0 | 0 | 0 | 0 | 1 | 21 | 0 |
| | 8.5 | 0 | 0 | 0 | 0 | 0 | 2 | 7 |
| Total | | 7 | 15 | 12 | 12 | 24 | 23 | 7 |
| % exact match | | 100 | 100 | 91.7 | 83.3 | 91.7 | 91.3 | 100 |
| % ±1 color block | | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| Blood (cells / μL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 25 | 80 | 200 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 25 | 0 | 0 | 0 |
| | 25 | 0 | 1 | 10 | 0 | 0 |
| | 80 | 0 | 0 | 2 | 10 | 0 |
| | 200 | 0 | 0 | 0 | 2 | 9 |
| Total | | 40 | 27 | 12 | 12 | 9 |
| % exact match | | 100 | 96.3 | 83.3 | 83.3 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 |
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| Ascorbic Acid (mg/dL) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0 | 10 | 25 | 50 | 100 |
| Proposed Device | 0 | 13 | 0 | 0 | 0 | 0 |
| | 10 | 0 | 22 | 1 | 1 | 0 |
| | 25 | 0 | 3 | 21 | 2 | 0 |
| | 50 | 0 | 0 | 1 | 24 | 0 |
| | 100 | 0 | 0 | 1 | 1 | 10 |
| Total | | 13 | 25 | 24 | 28 | 10 |
| % exact match | | 100 | 88 | 87.5 | 85.7 | 100 |
| % ±1 color block | | | 100 | 95.8 | 96.4 | 100 |
| Specific Gravity | Predicate Device | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1 | 1.005 | 1.01 | 1.015 | 1.02 | 1.025 | 1.03 |
| Proposed Device | 1 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 1.005 | 0 | 16 | 0 | 0 | 0 | 0 | 0 |
| | 1.01 | 0 | 1 | 19 | 1 | 0 | 0 | 0 |
| | 1.015 | 0 | 0 | 1 | 15 | 2 | 0 | 0 |
| | 1.02 | 0 | 0 | 0 | 1 | 12 | 1 | 0 |
| | 1.025 | 0 | 0 | 0 | 1 | 0 | 14 | 0 |
| | 1.03 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 9 | 17 | 20 | 18 | 14 | 15 | 7 |
| % exact match | | 100 | 94.1 | 95 | 83.3 | 85.7 | 93.3 | 100 |
| % ±1 color block | | | 100 | 100 | 94.4 | 100 | 100 | 100 |
| Ketone (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 5 | 14 | 40 | 80 | 160 |
| Proposed Device | NEG | 46 | 0 | 0 | 0 | 0 | 0 |
| | 5 | 0 | 10 | 0 | 0 | 0 | 0 |
| | 14 | 0 | 1 | 13 | 0 | 0 | 0 |
| | 40 | 0 | 0 | 1 | 9 | 0 | 0 |
| | 80 | 0 | 0 | 1 | 2 | 10 | 0 |
| | 160 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 46 | 11 | 15 | 11 | 10 | 7 |
| % exact match | | 100 | 90.9 | 86.7 | 81.81 | 100 | 100 |
| % ±1 color block | | | 100 | 93.3 | 100 | 100 | 100 |
| Bilirubin (mg/dL) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | NEG | 1 | 3 | 6 |
| Proposed Device | NEG | 44 | 0 | 0 | 0 |
| | 1 | 0 | 24 | 1 | 0 |
| | 3 | 0 | 1 | 18 | 0 |
| | 6 | 0 | 0 | 2 | 10 |
| Total | | 44 | 25 | 21 | 10 |
| % exact match | | 100 | 96 | 85.7 | 100 |
| % ±1 color block | | | 100 | 100 | 100 |
| Glucose (mg/dL) | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 90 | 270 | 550 | 1100 | 2000 |
| Proposed Device | NEG | 40 | 0 | 0 | 0 | 0 | 0 |
| | 90 | 0 | 11 | 0 | 0 | 0 | 0 |
| | 270 | 0 | 1 | 11 | 0 | 0 | 0 |
| | 550 | 0 | 0 | 1 | 11 | 0 | 0 |
| | 1100 | 0 | 0 | 0 | 1 | 11 | 0 |
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| | 2000 | 0 | 0 | 0 | 0 | 1 | 12 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total | | 40 | 12 | 12 | 12 | 12 | 12 |
| % exact match | | 100 | 91.7 | 91.7 | 91.7 | 91.7 | 100 |
| % ±1 color block | | | 100 | 100 | 100 | 100 | 100 |
Note:
1) Possible visual results of nitrite are 3(negative, positive 1 and 2), while possible instrumental results are 2 (negative and positive);
2) Instrumental reading does not include the result of non-hemolyzed blood.
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Expected values are included in the strips instructions for use and as shown in the table below:
| Analyte | Expected Values |
| --- | --- |
| Urobilinogen | 0.2-1 mg/dL |
| Bilirubin | Negative |
| Ketone | Negative |
| Blood | Negative |
| Protein | Negative or ± |
| Nitrite | Negative |
| Leukocytes | Negative |
| Glucose | Negative |
| Ascorbic Acid | 0-100 mg/dL |
| Specific Gravity | 1.000-1.030 |
| pH | 5.0-8.0 |
References:
1) "European Urinalysis Guidelines", the Scandinavian Journal of Clinical & Laboratory Investigation, Scand J Clin Lab Invest-Vol. 60-Supplement 231.2000.
2) "Compendium – Urinalysis with Test Strips" Roche Diagnostic, Combur® Reagent Strips.
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N. Instrument Name:
Healgen 500 and 800 urine analyzers for Healgen 11 and Healgen 10 reagent strips only.
O. System Descriptions:
1. Modes of Operation:
Semi-automatic reading of Healgen 11 and Healgen 10 reagent strips on Healgen 500 and Healgen 800 urine analyzers. The Healgen 4 reagent strip is for manual/visual reading only. Each reagent strip is single use and must be replaced with a new strip for additional readings. The labeling and user guide specify that the strips are for single use.
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?:
Yes ☐ X or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?:
Yes ☐ or No ☐ X
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the reagent strip as they are collected.
4. Specimen Sampling and Handling:
Healgen 500/800 urine analyzers are intended to be used with urine samples which can be applied directly to the reagent strip. Healgen 500 and Healgen 800 has a throughout of 120 tests per hour and 500 tests per hour, respectively.
5. Calibration:
The Healgen 500/800 urine analyzers use a check strip for a recommended once or twice a week calibration.
6. Quality Control:
Quality control monitoring is recommended (testing of known positive and negative controls) when a new bottle of reagent strips is first opened (at least every 12 hours). Use of water as a negative control is not recommended.
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P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Not applicable
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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