CYBOW READER, MODELS 300 & 720
Device Facts
| Record ID | K102188 |
|---|---|
| Device Name | CYBOW READER, MODELS 300 & 720 |
| Applicant | DFI Co., Ltd. |
| Product Code | KQO · Clinical Chemistry |
| Decision Date | Aug 9, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2900 |
| Device Class | Class 1 |
Indications for Use
The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semiautomated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.
Device Story
Semi-automated urine chemistry analyzers (Reader 300/720) process urine samples via CYBOW 11/10 reagent strips; reflectance photometry measures color intensity changes on strip pads. LED light source and contact image sensor (CIS) module capture optical data. Analyzers provide semi-quantitative/qualitative results for 11 analytes. Used in clinical settings by trained operators; samples collected in clean containers. Output displayed on device or printed; aids clinical decision-making for renal/metabolic disorders. Optional barcode reader for specimen ID. Reader 720 includes automated waste disposal; Reader 300 requires manual strip removal.
Clinical Evidence
Bench testing only. Precision evaluated using two levels of control materials across three sites (n=90 per level). Method comparison performed against predicate using clinical urine samples. Sensitivity defined as 95% detection of trace/positive results. Interference testing conducted for medically relevant concentrations of substances. No clinical diagnostic studies performed.
Technological Characteristics
Reflectance photometer; uses color image sensor for optical detection. Analyzes CYBOW 11 and 10 reagent strips. System includes internal printer. Software-based image analysis for color evaluation. Semiautomated operation.
Indications for Use
Indicated for semi-quantitative or qualitative measurement of urine analytes (glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, specific gravity) to aid in evaluation of renal, urinary, and metabolic disorders. For prescription, in vitro diagnostic use.
Regulatory Classification
Identification
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
Predicate Devices
- Clinitek 200+, 500 (K926359)
Related Devices
- K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control · ACON Laboratories, Inc. · May 11, 2015
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k102188
B. Purpose for Submission:
New urine chemistry analyzers to be used with previously cleared CYBOW 11 reagent strips (k052525) for pH, specific gravity, protein, glucose, bilirubin, urobilinogen, ketone, leukocytes, blood, nitrite, and ascorbic acid
C. Measurand:
Urine pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, specific gravity, ascorbic acid
D. Type of Test:
Qualitative and semi-quantitative measurements based on reflectance photometry
E. Applicant:
DFI Co., Ltd.
F. Proprietary and Established Names:
CYBOW Reader 300 and CYBOW Reader 700 urine chemistry analyzers
CYBOW 11 Reagent Strip
CYBOW 10 Reagent Strip
G. Regulatory Information:
| Name | Regulation | Product Code | Classification |
| --- | --- | --- | --- |
| Urinary glucose (non-quantitative) test system. | 21 CFR §862.1340 | JIL | II |
| Occult blood test | 21 CFR §864.6550 | JIO | II |
| Urinary urobilinogen (non-quantitative) test system | 21 CFR §862.1785 | CDM | I |
| Urinary bilirubin and its conjugates (non-quantitative) test system | 21 CFR §862.1115 | JJB | I |
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| Name | Regulation | Product Code | Classification |
| --- | --- | --- | --- |
| Ketones (non-quantitative) test system | 21 CFR §862.1435 | JIN | I |
| Urinary protein or albumin (non-quantitative) test system | 21 CFR §862.1645 | JIR | I |
| Nitrite (non-quantitative) test system | 21 CFR §862.1510 | JMT | I |
| Leukocyte peroxidase test | 21 CFR §864.7675 | LJX | I |
| Urinary pH (non-quantitative) test system | 21 CFR §862.1550 | CEN | I |
| Specific Gravity | 21 CFR§862.2800 | JRE | I |
| Ascorbic acid test system | 21 CFR §862.1095 | JMA | I |
| Automated Urinalysis System | 21 CFR §862. 2900 | KQO | I |
Panel:
(75) Clinical Chemistry and (81) Hematology
H. Intended Use:
1. Intended use(s):
See indication(s) for use below.
2. Indication(s) for use:
The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quantitatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.
3. Special conditions for use statement(s):
For use only with CYBOW 11 reagent strips and CYBOW 10 reagent strips (does not contain ascorbic acid pad)
For prescription and in vitro diagnostic use
4. Special instrument requirements:
CYBOW Reader 300 and CYBOW Reader 720
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I. Device Description:
The CYBOW Reader 300 and CYBOW Reader 720 urinalysis systems are intended for use with CYBOW 11 and CYBOW 10 reagent strips for the qualitative and semi-quantitative determination of urine analytes including glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. The CYBOW 10 reagent strips are identical to the CYBOW 11 reagent strips except they do not include an ascorbic acid test pad. Urine color may be entered manually by the operator, however the test system does not compensate for urine color
The CYBOW Reader 300 has a test throughput of 300 tests per hour versus the CYBOW Reader 720 which has a test throughput of 720 tests per hour. They are technologically very similar and each analyzer includes a built-in printer. An optional barcode reader is available. The CYBOW Reader 720 has a waste box for used reagent strips whereas on the CYBOW 300 the used strips must be dispensed manually by the user.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Bayer Clinitek 200+ with Multistix 10SG reagent strips
2. Predicate 510(k) number(s):
k926359
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | A semi-automated analyzer which is designed to read test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | Same |
| Analyzer Technology | Reflectance Photometry | Same |
| Sample Matrix | Urine | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Test parameters | Includes ascorbic acid test pad on test strip | Does not include ascorbic acid test pad |
| Measuring sensor | CIS module | Photodiode |
| Light source | LED | Xenon |
| Throughput/Tests per hour | CYBOW Reader 300: 300 tests per hour | Clinitek 200+: 360 per hour |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | CYBOW Reader 720: 720 tests per hour | |
K. Standard/Guidance Document Referenced (if applicable):
ISO 14971:2007 Medical devices—Application of risk management to medical devices
CLSI EP5-A2 Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline Second Edition
CLSI EP7-A: Interference Testing in Clinical Chemistry, Approved Guideline
CLSI EP9-A: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
L. Test Principle:
The CYBOW Reader 300 and CYBOW Reader 720 are reflectance photometers that analyze the intensity and color of light reflected from the reagent areas of the urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a contact image sensor (CIS) module, the optical system reads the color change in the urine strips after the sample is applied.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The sponsor evaluated precision of the test systems using two levels of control materials (MAS Urinalysis Control, Level 1 and Level 2). Precision was performed at three point of care sites by three operators on the CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers.
The within run precision study included three different CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers and three lots of urine test strips. Each operator tested ten test strips from each lot number on each analyzer in one testing day.
The within day precision study included three different CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers and three lots of urine test strips. Each operator tested each lot of test strips on each analyzer, once per day for 10 days. The results for the three testing sites combined are summarized in the following tables:
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| Level 1 Control -CYBOW Reader 300 | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Within-run (n=90) | | Within-day (n=90) | |
| Analyte | Expected result | Exact Agreement (%) | Within +/- 1 block (%) | Exact Agreement (%) | Within +/- 1 block (%) |
| Urobilinogen | Normal | 100 | 100 | 100 | 100 |
| Glucose | Negative | 100 | 100 | 100 | 100 |
| Bilirubin | Negative | 100 | 100 | 100 | 100 |
| Ketones | Negative | 100 | 100 | 100 | 100 |
| SG | 1.020 | 100 | 100 | 97.8 | 100 |
| Blood | Negative | 100 | 100 | 100 | 100 |
| pH | 6 | 100 | 100 | 98.9 | 100 |
| Protein | Negative | 100 | 100 | 100 | 100 |
| Nitrite | Negative | 100 | 100 | 100 | 100 |
| Leukocytes | Negative | 100 | 100 | 100 | 100 |
| Ascorbic Acid | Negative | 100 | 100 | 100 | 100 |
| Level 2 Control -CYBOW Reader 300 | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Within-run (n=90) | | Within-day (n=90) | |
| Analyte | Expected Result | Exact Agreement (%) | Within +/- 1 block (%) | Exact Agreement (%) | Within +/- 1 block (%) |
| Urobilinogen | 4 mg/dL | 98.9 | 100 | 98.9 | 100 |
| Glucose | 1000 mg/dL | 100 | 100 | 100 | 100 |
| Bilirubin | 4 mg/dL | 98.9 | 100 | 100 | 100 |
| Ketones | 40 mg/dL | 98.9 | 100 | 98.9 | 100 |
| SG | 1.020 | 98.9 | 100 | 98.9 | 100 |
| Blood | 250 RBC/μl | 100 | 100 | 98.9 | 100 |
| pH | 7 | 100 | 100 | 97.8 | 100 |
| Protein | 100 mg/dL | 100 | 100 | 100 | 100 |
| Nitrite | Pos | 100 | 100 | 100 | 100 |
| Leukocytes | 75 WBC/μl | 98.9 | 100 | 98.9 | 100 |
| Ascorbic Acid | 20 mg/dL | 100 | 100 | 100 | 100 |
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| Level 1 Control -CYBOW Reader 720 | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Within-run (n=90) | | Within-day (n=90) | |
| Item | Test Results | Exact Agreement (%) | Within +/- 1 block (%) | Exact Agreement (%) | Within +/- 1 block (%) |
| Urobilinogen | Normal | 100 | 100 | 100 | 100 |
| Glucose | Negative | 100 | 100 | 100 | 100 |
| Bilirubin | Negative | 100 | 100 | 100 | 100 |
| Ketones | Negative | 100 | 100 | 100 | 100 |
| SG | 1.020 | 98.9 | 100 | 100 | 100 |
| Blood | Negative | 100 | 100 | 100 | 100 |
| pH | 6 | 98.9 | 100 | 98.9 | 100 |
| Protein | Negative | 100 | 100 | 100 | 100 |
| Nitrite | Negative | 100 | 100 | 100 | 100 |
| Leukocytes | Negative | 100 | 100 | 100 | 100 |
| Ascorbic Acid | Negative | 100 | 100 | 100 | 100 |
| Level 2 Control -CYBOW Reader 720 | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Within-run (n=90) | | Within-day (n=90) | |
| Item | Test Results | Exact Agreement (%) | Within +/- 1 block (%) | Exact Agreement (%) | Within +/- 1 block (%) |
| Urobilinogen | 4 mg/dL | 100 | 100 | 98.9 | 100 |
| Glucose | 1000 mg/dL | 100 | 100 | 100 | 100 |
| Bilirubin | 4 mg/dL | 98.9 | 100 | 100 | 100 |
| Ketones | 40 mg/dL | 98.9 | 100 | 100 | 100 |
| SG | 1.020 | 100 | 100 | 97.8 | 100 |
| Blood | 250 RBC/μl | 98.9 | 100 | 100 | 100 |
| pH | 7 | 98.9 | 100 | 98.9 | 100 |
| Protein | 100 mg/dL | 98.9 | 100 | 100 | 100 |
| Nitrite | Pos | 100 | 100 | 100 | 100 |
| Leukocytes | 75 WBC/μl | 100 | 100 | 98.9 | 100 |
| Ascorbic Acid | 20 mg/dL | 100 | 100 | 100 | 100 |
b. Linearity/assay reportable range:
The sponsor validated the values assigned to each color pad for each analyte by testing pooled, negative urine spiked with commercially available standards to specific target concentrations. Each concentration of analyte was tested 10 times, across 3 lots of strips for a total of 30 measurements at each concentration. The study
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was performed with 3 serial numbers of CYBOW Reader 300 and CYBOW Reader 720 analyzers (n = 90). The results for the three serial numbers combined are summarized in the tables below:
## CYBOW Reader 300
Urobilinogen
| 8 mg/dL | | | | 1 | 89 |
| --- | --- | --- | --- | --- | --- |
| 4 mg/dL | | | 2 | 89 | 1 |
| 2 mg/dL | | | 88 | | |
| 1 mg/dL | | 90 | | | |
| 0.1 mg/dL | 90 | | | | |
| | 0.1 | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8 mg/dL |
Expected Results
Glucose
| 1000 mg/dL | | | | 1 | 88 |
| --- | --- | --- | --- | --- | --- |
| 500 mg/dL | | | 2 | 89 | 2 |
| 250 mg/dL | | | 88 | | |
| 100 mg/dL | | 90 | | | |
| Neg | 90 | | | | |
| | Neg | 100 mg/dL | 250 mg/dL | 500 mg/dL | 1000 mg/dL |
Expected Results
Bilirubin
| 4 mg/dL | | | 1 | 90 |
| --- | --- | --- | --- | --- |
| 2 mg/dL | | 1 | 87 | |
| 1 mg/dL | | 89 | 2 | |
| Neg | 90 | | | |
| | Neg | 1 mg/dL | 2 mg/dL | 4 mg/dL |
Expected Results
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Ketones
| 100 mg/dL | | | | | 90 |
| --- | --- | --- | --- | --- | --- |
| 40 mg/dL | | | 3 | 89 | |
| 15 mg/dL | | 1 | 87 | 1 | |
| 5 mg/dL | | 89 | | | |
| Neg | 90 | | | | |
| | Neg | 5 mg/dL | 15 mg/dL | 40 mg/dL | 100 mg/dL |
Expected Results
Specific Gravity
| 1.030 | | | | | | 2 | 90 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.025 | | | | | 2 | 87 | |
| 1.020 | | | | 2 | 85 | 1 | |
| 1.015 | | | | 87 | | | |
| 1.010 | | 4 | 90 | 1 | | | |
| 1.005 | | 85 | | | | | |
| 1.000 | 90 | 1 | | | | | |
| | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
Expected Results
Blood
| 250 RBC/μL | | | 1 | 89 |
| --- | --- | --- | --- | --- |
| 50 RBC/ μL | | | 89 | 1 |
| 10 RBC/ μL | | 90 | | |
| Neg | 90 | | | |
| | Neg | 10 RBC/ μL | 50 RBC/ μL | 250 RBC/ μL |
Expected Results
pH
| 9 | | | | | 1 | 90 |
| --- | --- | --- | --- | --- | --- | --- |
| 8 | | | | | 89 | |
| 7 | | | 1 | 88 | | |
| 6.5 | | 1 | 89 | 2 | | |
| 6 | | 89 | | | | |
| 5 | 90 | | | | | |
| | 5 | 6 | 6.5 | 7 | 8 | 9 |
Expected Results
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# Protein
| 1000 mg/dL | | | | | 1 | 90 |
| --- | --- | --- | --- | --- | --- | --- |
| 300 mg/dL | | | | 2 | 88 | |
| 100 mg/dL | | | | 87 | 1 | |
| 30 mg/dL | | 1 | 89 | 1 | | |
| 15 mg/dl (Trace) | | 89 | 1 | | | |
| Neg | 90 | | | | | |
| | Neg | 15 mg/dL | 30 mg/dL | 100mg/dL | 300mg/dL | 1000mg/dL |
Expected Results
# Nitrite
| Positive (10 mg/dL) | | | 90 |
| --- | --- | --- | --- |
| Trace (0.05 mg/dL) | | 90 | |
| Negative | 90 | | |
| | Negative | 0.05 mg/dl | 10 mg/dl |
Expected Results
# Leukocytes
| 500 Leu/μL | | | | 90 |
| --- | --- | --- | --- | --- |
| 75 Leu/μL | | 2 | 88 | |
| 25 Leu/μL | | 88 | 2 | |
| Neg | 90 | | | |
| | Neg | 25 Leu/μL | 75 Leu/μL | 500 Leu/μL |
Expected Results
# Ascorbic Acid
| 40mg/dL | | 2 | 90 |
| --- | --- | --- | --- |
| 20mg/dL | | 88 | |
| Neg | 90 | | |
| | Neg | 20 mg/dL | 40 mg/dL |
Expected Results
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# CYBOW Reader 720
## Urobilinogen
| 8 mg/dL | | | | | 90 |
| --- | --- | --- | --- | --- | --- |
| 4 mg/dL | | | 1 | 89 | |
| 2 mg/dL | | | 89 | 1 | |
| 1 mg/dL | | 90 | | | |
| 0.1 mg/dL | 90 | | | | |
| | 0.1 mg/dL | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8 mg/dL |
Expected Results
## Glucose
| 1000 mg/dL | | | | 3 | 90 |
| --- | --- | --- | --- | --- | --- |
| 500 mg/dL | | | 2 | 86 | |
| 250 mg/dL | | | 88 | 1 | |
| 100 mg/dL | | 90 | | | |
| Neg | 90 | | | | |
| | Neg | 100 mg/dL | 250 mg/dL | 500 mg/dL | 1000 mg/dL |
Expected Results
## Bilirubin
| 4mg/dL | | | 1 | 90 |
| --- | --- | --- | --- | --- |
| 2mg/dL | | 1 | 89 | |
| 1mg/dL | | 89 | | |
| Neg | 90 | | | |
| | Neg | 1mg/dL | 2mg/dL | 4mg/dL |
Expected Results
## Ketones
| 100 mg/dL | | | | | 90 |
| --- | --- | --- | --- | --- | --- |
| 40 mg/dL | | | 3 | 90 | |
| 15 mg/dL | | | 86 | | |
| 5 mg/dL | | 90 | 1 | | |
| Neg | 90 | | | | |
| | Neg | 5 mg/dL | 15 mg/dL | 40 mg/dL | 100 mg/dL |
Expected Results
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# Specific Gravity
| 1.030 | | | | | | 2 | 90 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.025 | | | | | | 87 | |
| 1.020 | | | | 2 | 89 | 1 | |
| 1.015 | | | 1 | 87 | 1 | | |
| 1.010 | | 1 | 88 | 1 | | | |
| 1.005 | | 88 | 1 | | | | |
| 1.000 | 90 | 1 | | | | | |
| | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
Expected Results
# Blood
| 250 RBC/ μL | | | | 88 |
| --- | --- | --- | --- | --- |
| 50 RBC/ μL | | | 90 | |
| 10 RBC/ μL | | 90 | | |
| Neg | 90 | | | |
| | Neg | 10 RBC/ μL | 50 RBC/ μL | 250 RBC/ μL |
Expected Results
# pH
| 9 | | | | | | 90 |
| --- | --- | --- | --- | --- | --- | --- |
| 8 | | | | | 90 | |
| 7 | | | 1 | 88 | | |
| 6.5 | | 1 | 89 | 2 | | |
| 6 | | 89 | | | | |
| 5 | 90 | | | | | |
| | 5 | 6 | 6.5 | 7 | 8 | 9 |
Expected Results
# Protein
| 1000 mg/dL | | | | | | 90 |
| --- | --- | --- | --- | --- | --- | --- |
| 300 mg/dL | | | | 2 | 88 | |
| 100 mg/dL | | | | 87 | 1 | |
| 30 mg/dL | | 2 | 89 | 1 | | |
| 15 mg/dL | | 88 | 1 | | | |
| Neg | 90 | | | | | |
| | Neg | 15 mg/dL | 30 mg/dL | 100mg/dL | 300mg/dL | 1000mg/dL |
Expected Results
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Nitrite
| Positive (10 mg/dL) | | | 90 |
| --- | --- | --- | --- |
| Trace (0.05 mg/dL) | | 90 | |
| Negative | 90 | | |
| | Negative | 0.05mg/dL | 10mg/dL |
Expected Results
Leukocytes
| 500 Leu/μL | | | 2 | 89 |
| --- | --- | --- | --- | --- |
| 75 Leu/μL | | 1 | 88 | 1 |
| 25 Leu/μL | | 89 | | |
| Neg | 90 | | | |
| | Neg | 25 Leu/μL | 75 Leu/μL | 500 Leu/μL |
Expected Results
Ascorbic Acid
| 40mg/dL | | 3 | 89 |
| --- | --- | --- | --- |
| 20mg/dL | | 87 | 1 |
| Negative | 90 | | |
| | Negative | 20 mg/dL | 40 mg/dL |
The data supports the sponsor's reportable range of color pads stated on the product label:
| Test | Reportable Range |
| --- | --- |
| Urobilinogen | 0.1,1 mg/dL, 2,4, and 8 mg/dL |
| Glucose | Neg, 100, 250, 500 and 1000mg/dL |
| Bilirubin | Neg, 1 (+), 2 (++) and 4 (+++) mg/dL |
| Ketones | Neg, 5, 15, 40, and 100 mg/dL |
| Specific Gravity | 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 |
| Blood | Neg, 10, 50, and 250 RBC/ ul |
| pH | 5, 6, 6.5, 7, 8, 9 |
| Protein | Neg, 15, 30, 100, 300 and 1000mg/dL |
| Nitrite | Neg, 0.05, and 10mg/dL |
| Leukocytes | Neg, 25, 75, and 500 Leu/μl |
| Ascorbic acid | Neg, 20, and 40 mg/dL |
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The stability characteristics of the strips was reviewed under k052525
d. Detection limit:
The sensitivity of the test strips when read by CYBOW Reader 300 and CYBOW Reader 720 analyzers was determined by spiking positive urine samples with known concentrations for each analyte. Each urine sample was tested with three lots of test strips in 10 replicates, for a total of 30 replicates. Sensitivity was defined as the concentration in which 95% of the contrived pooled measurements were trace or positive. *For urobilinogen, the sensitivity study represents the concentration in which 95% of the measurements were positive at the first above normal color pad.
| Test | Claim
(Package Insert CYBOW 11) | Point at which sensitivity meets criteria of >95% detection |
| --- | --- | --- |
| Urobilinogen | 2 mg/dL* | 2 mg/dL* |
| Glucose | 100mg/dL | 100mg/dL |
| Bilirubin | 1mg/dL | 1mg/dL |
| Ketones | 5mg/dL | 5mg/dL |
| Blood | 5 RBC/ uL | 5 RBC/ uL |
| Protein | 15mg/dL | 15mg/dL |
| Nitrite | 0.05mg/dL | 0.05mg/dL |
| Leukocytes | 15-25 Leu/μL | 15 Leu/μL |
| Ascorbic Acid | 20mg/dL | 20mg/dL |
The lower limits of detection for pH and Specific Gravity are 5 and 1.000 respectively.
e. Analytical specificity:
The effect of potentially interfering substances was evaluated using the CYBOW 300 and CYBOW 720 readers and CYBOW 11 test strips. The sponsor tested medically relevant concentrations of each substance using urine pools spiked with concentrations of analyte corresponding to the claimed assay ranges of the devices. All potential result/color blocks were evaluated. The results are summarized below.
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| Test | Interfering Analyses | Impact on CYBOW Reader 300 and CYBOW Reader 720 test result |
| --- | --- | --- |
| Urobilinogen | p-amino salicylic acid (≥12500mg/L) | False positive |
| | Azo gantrinsin (Sulfamethoxazol) (≥1000mg/L) | False positive |
| Glucose | Chlorine Bleach (≥100mg/L) | False positive |
| | Mecetronium Etilsulfate (≥40mg/L) | False positive |
| | Ascorbic acid (≥40mg/dL) | False negative |
| | Ketones (≥40mg/dL) | False negative |
| Bilirubin | Selenium(≥2000mg/L) | False Positive |
| | p-amino salicylic acid(≥12500mg/L) | False positive |
| | Urobilinogen(≥120mg/L) | False positive |
| | Penicillin(≥7000mg/L) | False positive |
| | Ascorbic acid (≥40mg/dL) | False negative |
| Ketones | Formaline(≥1500mg/L) | False positive |
| | Captopril (≥50mg/L) | False positive |
| Blood(hemolyzed and non-hemolyzed) | Nitrofurantion(≥200mg/L) | False positive |
| | Ascorbic acid(≥30mg/dL) | False negative |
| | Leukocytes(≥500 WBC/μL) | False positive |
| Specific gravity | Buffered alkaline samples(pH≥9) | Low reported specific gravity |
| Protein | Sodium acetate(≥2800mg/dL) | False positive |
| | High pH(>9) | False positive |
| | Acetaminophen(≥500mg/L) | False positive |
| Nitrite | Ascorbic acid(≥40mg/dL) | False negative |
| Leukocytes | Glucose(≥2000mg/dL) | False negative |
| | Albumin(≥1000mg/dL) | False negative |
| | Formaldehyde(≥1000mg/L) | False positive |
| | Captopril(≥100mg/L) | False negative |
| | Tetracycline(≥400mg/L) | False positive |
In addition, the labeling includes a reference for known interference from MESNA. Gyorgy Csako, Mesna and Other Free-Sulfhydryl Compounds Produce False-Positive Results in a Urine Test Strip Method for Ascorbic Acid, Clin Chem 1999 45: 2295-2296.
The labeling clearly states that the test system does not compensate for urine color. However, urine color may be documented by the operator in the test report.
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f. Assay cut-off:
Not applicable
## 2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies were performed with clinical samples at three point of care sites. The performance of the CYBOW Reader 300 and CYBOW Reader 720 with CYBOW 11 test strips was compared to the predicate device with Multistix® 10SG test strips). For ascorbic acid, performance was compared to the Uriscan S-300 with Uriscan 11SG test strips (k980047). The sponsor states that the operators at the point of care sites had education backgrounds similar to those individuals expected to be the intended users of the device.
Fresh urines were obtained at the different clinical sites. They were evaluated using three lots of test strips and three serial numbers of CYBOW Reader 300 and CYBOW Reader 720 analyzers. The summarized results are found in the tables below.
### CYBOW Reader 300
| Urobilinogen | | Predicate device (mg/dL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Norm | 1 | 2 | 4 | 8 |
| New device (mg/dL) | 8 | | | | 4 | 36 |
| | 4 | | | 3 | 40 | 1 |
| | 2 | | 2 | 43 | 1 | |
| | 1 | | 47 | 2 | | |
| | 0.1 | 688 | | | | |
| Total | | 688 | 49 | 48 | 45 | 37 |
| Exact agreement | | 100% | 96% | 90% | 89% | 97% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
| Glucose | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 100 | 250 | 500 | 1000 | 2000 |
| New device (mg/dL) | 1000 | | | | 3 | 31 | 38 |
| | 500 | | | 6 | 54 | 1 | 1 |
| | 250 | | 5 | 58 | 5 | | |
| | 100 | | 59 | | | | |
| | NEG | 606 | | | | | |
| Total | | 606 | 64 | 64 | 62 | 32 | 39 |
| Exact agreement | | 100% | 92% | 91% | 87% | 97% | 97% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 97% |
{15}
| Bilirubin | | Predicate device (mg/dL) | | | |
| --- | --- | --- | --- | --- | --- |
| | | NEG | 1 | 2 | 4 |
| New device (mg/dL) | 4 | | | | 18 |
| | 2 | | 4 | 33 | |
| | 1 | | 51 | 5 | |
| | NEG | 756 | | | |
| Total | | 756 | 55 | 38 | 18 |
| Exact agreement | | 100% | 93% | 87% | 100% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% |
| Ketones | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 5 | 15 | 40 | 80 | 160 |
| New device (mg/dL) | 100 | | | | 6 | 36 | 8 |
| | 40 | | | | 44 | | |
| | 15 | | 2 | 57 | | | |
| | 5 | | 48 | 5 | | | |
| | NEG | 661 | | | | | |
| Total | | 661 | 50 | 62 | 50 | 36 | 8 |
| Exact agreement | | 100% | 96% | 92% | 88% | 100% | 100% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% |
| Leukocytes | | Predicate device(WBC/μL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 15 | 70 | 125 | 500 |
| New device (WBC/μL) | 500 | | | 2 | 10 | 120 |
| | 75 | | 1 | 125 | 113 | 3 |
| | 25 | | 99 | 3 | | |
| | NEG | 391 | | | | |
| Total | | 391 | 100 | 130 | 123 | 123 |
| Exact agreement | | 100% | 99% | 96% | 92% | 98% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
{16}
| Blood | | Predicate device (RBC/ μL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 25 | 80 | 250 |
| New device (RBC/ μL) | 250 | | | | 3 | 58 |
| | 50 | | 1 | 6 | 57 | 1 |
| | 10 | | 32 | 62 | | |
| | NEG | 80 | | | | |
| Total | | 80 | 33 | 68 | 60 | 59 |
| Exact agreement | | 100% | 97% | 91% | 95% | 98% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
| Protein | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 15 | 30 | 100 | 300 | 1000 |
| New device (mg/dL) | 1000 | | | | | 2 | 16 |
| | 300 | | | | 2 | 39 | 1 |
| | 100 | | | 4 | 62 | | |
| | 30 | | 6 | 93 | 2 | | |
| | 15 | | 113 | 2 | | | |
| | NEG | 525 | | | | | |
| Total | | 525 | 119 | 99 | 66 | 41 | 17 |
| Exact agreement | | 100% | 95% | 94% | 94% | 95% | 94% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% |
| Nitrites | | Predicate device | |
| --- | --- | --- | --- |
| | | NEG | Pos |
| New device | Pos | | 310 |
| | Trace | | 95 |
| | NEG | 460 | |
| Total | | 462 | 405 |
| Exact agreement | | 100% | 100% |
| Within ± 1 Color Block | | 100% | 100% |
{17}
| Specific Gravity | | Predicate device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| New device | 1.030 | | | | | | 5 | 88 |
| | 1.025 | | | | | 6 | 89 | 2 |
| | 1.020 | | | | 8 | 166 | 3 | |
| | 1.015 | | | 6 | 132 | 8 | | |
| | 1.010 | | 8 | 151 | 8 | | | |
| | 1.005 | 1 | 114 | 8 | | | | |
| | 1.000 | 63 | 1 | | | | | |
| Total | | 64 | 123 | 165 | 148 | 180 | 97 | 90 |
| Exact agreement | | 98% | 93% | 92% | 89% | 92% | 92% | 98% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| pH | | Predicate device | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5 | 5.5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 | 9 |
| New device | 9 | | | | | | | | 13 | 10 |
| | 8 | | | | | | 18 | 35 | 14 | |
| | 7 | | | | 6 | 48 | 19 | | | |
| | 6.5 | | | 5 | 39 | 6 | | | | |
| | 6 | | 33 | 48 | 1 | | | | | |
| | 5 | 51 | 14 | | | | | | | |
| Total | | 51 | 47 | 53 | 46 | 54 | 37 | 35 | 27 | 10 |
| Exact agreement | | 100% | 100% | 91% | 85% | 89% | 100% | 100% | 100% | 100% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
{18}
19
| Ascorbic acid | | Predicate device | | |
| --- | --- | --- | --- | --- |
| | | NEG | 20 | 40 |
| New device (mg/dL) | 40 | | 2 | 38 |
| | 20 | | 67 | 3 |
| | NEG | 170 | | |
| Total | | 170 | 69 | 41 |
| Exact agreement | | 100% | 97% | 93% |
| Within ± 1 Color Block | | 100% | 100% | 100% |
## CYBOW Reader 720
| Urobilinogen | | Predicate device (mg/dL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Norm | 1 | 2 | 4 | 8 |
| New device (mg/dL) | 8 | | | | 5 | 35 |
| | 4 | | | 4 | 39 | 2 |
| | 2 | | 4 | 43 | 1 | |
| | 1 | | 45 | 1 | | |
| | 0.1 | 688 | | | | |
| Total | | 688 | 49 | 48 | 45 | 37 |
| Exact agreement | | 100% | 92% | 90% | 87% | 95% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
| Glucose | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 100 | 250 | 500 | 1000 | 2000 |
| New device (mg/dL) | 1000 | | | | 6 | 29 | 38 |
| | 500 | | | 6 | 51 | 3 | 1 |
| | 250 | | 3 | 56 | 5 | | |
| | 100 | | 61 | 2 | | | |
| | NEG | 606 | | | | | |
| Total | | 606 | 64 | 64 | 62 | 32 | 39 |
| Exact agreement | | 100% | 95% | 88% | 82% | 91% | 97% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 97% |
{19}
| Bilirubin | | Predicate device (mg/dL) | | | |
| --- | --- | --- | --- | --- | --- |
| | | NEG | 1 | 2 | 4 |
| New device (mg/dL) | 4 | | | | 16 |
| | 2 | | 6 | 33 | 2 |
| | 1 | | 49 | 5 | |
| | NEG | 756 | | | |
| Total | | 756 | 55 | 38 | 18 |
| Exact agreement | | 100% | 89% | 87% | 89% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% |
| Ketones | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 5 | 15 | 40 | 80 | 160 |
| New device (mg/dL) | 100 | | | | 9 | 34 | 8 |
| | 40 | | | | 41 | 2 | |
| | 15 | | 2 | 53 | | | |
| | 5 | | 48 | 9 | | | |
| | NEG | 661 | | | | | |
| Total | | 661 | 50 | 62 | 50 | 36 | 8 |
| Exact agreement | | 100% | 96% | 85% | 82% | 94% | 100% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% |
| Leukocytes | | Predicate device (WBC/μL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 15 | 70 | 125 | 500 |
| New device (WBC/ μL) | 500 | | | 2 | 10 | 113 |
| | 75 | | | 123 | 113 | 10 |
| | 25 | | 100 | 5 | 0 | |
| | NEG | 391 | | | | |
| Total | | 391 | 100 | 130 | 123 | 123 |
| Exact agreement | | 100% | 100% | 95% | 92% | 92% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
{20}
| Blood | | Predicate device (RBC/ μL) | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 10 | 25 | 80 | 250 |
| New device (RBC/ μL) | 250 | | | | 3 | 58 |
| | 50 | | 1 | 7 | 57 | 1 |
| | 10 | | 32 | 61 | | |
| | NEG | 80 | | | | |
| Total | | 80 | 33 | 68 | 60 | 59 |
| Exact agreement | | 100% | 97% | 90% | 95% | 98% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% |
| Protein | | Predicate device (mg/dL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | NEG | 15 | 30 | 100 | 300 | 1000 |
| New device (mg/dL) | 1000 | | | | | 2 | 16 |
| | 300 | | | | 4 | 38 | 1 |
| | 100 | | | 4 | 61 | 1 | |
| | 30 | | 12 | 93 | 2 | | |
| | 15 | | 106 | 2 | | | |
| | NEG | 525 | | | | | |
| Total | | 525 | 118 | 99 | 67 | 41 | 17 |
| Exact agreement | | 100% | 90% | 94% | 91% | 93% | 94% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% |
| Nitrites | | Predicate device | |
| --- | --- | --- | --- |
| | | NEG | Pos |
| New device | Pos | | 306 |
| | Trace | 2 | 99 |
| | NEG | 460 | 1 |
| Total | | 462 | 405 |
| Exact agreement | | 100% | 100% |
| Within ± 1 Color Block | | 100% | 100% |
{21}
| Specific gravity | | Predicate device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| New device | 1.030 | | | | | | 4 | 85 |
| | 1.025 | | | | | 5 | 89 | 5 |
| | 1.020 | | | | 9 | 169 | 4 | |
| | 1.015 | | | 11 | 131 | 6 | | |
| | 1.010 | | 10 | 138 | 8 | | | |
| | 1.005 | 6 | 109 | 16 | | | | |
| | 1.000 | 58 | 4 | | | | | |
| Total | | 64 | 123 | 165 | 148 | 180 | 97 | 90 |
| Exact agreement | | 91% | 89% | 84% | 89% | 94% | 92% | 94% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| pH | | Predicate device | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5 | 5.5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 | 9 |
| New device | 9 | | | | | | | 2 | 16 | 10 |
| | 8 | | | | | | 15 | 33 | 11 | |
| | 7 | | | | 4 | 49 | 22 | | | |
| | 6.5 | | | 5 | 41 | 5 | | | | |
| | 6 | | 29 | 48 | 1 | | | | | |
| | 5 | 51 | 18 | | | | | | | |
| Total | | 51 | 47 | 53 | 46 | 54 | 37 | 35 | 27 | 10 |
| Exact agreement | | 100% | 100% | 91% | 89% | 91% | 100% | 94% | 100% | 100% |
| Within ± 1 Color Block | | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| Ascorbic acid | | Predicate device | | |
| --- | --- | --- | --- | --- |
| | | NEG | 20 | 40 |
| New device (mg/dL) | 40 | | | 38 |
| | 20 | | 69 | 3 |
| | NEG | 170 | | |
| Total | | 170 | 69 | 41 |
| Exact agreement | | 100% | 100% | 93% |
| Within One Block | | 100% | 100% | 100% |
{22}
b. Matrix comparison:
Not applicable, the device is only intended for urine specimens.
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:
References for the analyte expected values are stated in the labeling based on literature.
N. Instrument Name:
CYBOW Reader 300 and CYBOW Reader 720
O. System Descriptions:
1. Modes of Operation:
Semi-automated. User performs test strip procedure then loads the test strip onto analyzer.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ x ☐ or No ☐
23
{23}
3. Specimen Identification:
Manual or by barcode reader
4. Specimen Sampling and Handling:
The instructions state that users should collect urine in clean, dry container and test as soon as possible.
5. Calibration:
Calibration strips are used for calibration. They are plastic white strips with defined reflectance characteristics. Calibration should be performed prior to first use of the analyzer and then every 4 weeks using the calibration strip provided with the analyzer. Each strip should only be used once. Users should contact Customer Service for information on obtaining additional strips.
6. Quality Control:
Recommendations for quality control are described in the labeling. Additionally, users should follow local, state and federal regulations.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
None
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.
24
