CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
Device Facts
| Record ID | K140717 |
|---|---|
| Device Name | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT |
| Applicant | Siemens Healthcare Diagnostics |
| Product Code | KQO · Clinical Chemistry |
| Decision Date | Nov 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2900 |
| Device Class | Class 1 |
Indications for Use
The CLINITEK Novus® Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus Cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus 10 Urinalysis Cassette is intended for the semi-quantitative measurement of the following parameters in urine: bilirubin, blood (occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein, color, and urobilinogen. These measurements are used to assist diagnosis in the following areas: - Carbohydrate metabolism (such as diabetes mellitus) - Kidney function - Liver function - Metabolic disorders - Urinary tract infection For in vitro diagnostic use. The CLINITEK Novus® Calibration Kit is intended to be used with the CLINITEK Novus Urinalysis Cassette to calibrate the CLINITEK Novus Automated Urine Chemistry Analyzer. This product is for professional in vitro diagnostic use.
Device Story
The CLINITEK Novus is a fully automated batch urine chemistry analyzer for clinical laboratories. It processes urine samples from barcoded tubes using a sampling pipette that dispenses urine onto reagent test pads (CLINITEK Novus 10 Cassette) and an SG sensor. The system uses a CMOS digital imager to record color and intensity of light reflected from reacted test pads, illuminated by two pairs of LEDs. Specific gravity is measured via a fiber optic refractive index method; clarity is determined by light transmission and scattering. The system performs automated rinse cycles between samples. Results are displayed on the instrument, printed, or sent to a Laboratory Information System (LIS). The device assists clinicians in diagnosing metabolic disorders, kidney/liver function, and UTIs. It includes a 3-point calibration process using a dedicated calibration kit. The system provides semi-quantitative and qualitative results, improving workflow efficiency in high-volume clinical settings.
Clinical Evidence
Bench testing only. Performance evaluated via precision/reproducibility studies (3 analyzers, 10 days, 3 levels of controls) and method comparison against the predicate (3 sites, up to 2773 specimens). Results showed high agreement (exact match and within ±1 block) across all analytes. Analytical sensitivity (limit of detection) and specificity (interference testing with various substances) were established. No clinical prospective/retrospective studies on patient outcomes were required.
Technological Characteristics
System uses a CMOS digital imager for reflectance photometry and fiber optic refractive index sensing for specific gravity. Reagents are provided in a test card cassette format. Connectivity includes LIS integration. Calibration is performed using a 4-solution liquid kit. Software includes automated cleaning cycles and humidity quality checks. Complies with CLSI EP7-A2 for interference testing.
Indications for Use
Indicated for professional in vitro diagnostic use in clinical laboratories to assist in the diagnosis of carbohydrate metabolism disorders (e.g., diabetes mellitus), kidney function, liver function, metabolic disorders, and urinary tract infections via semi-quantitative measurement of urine analytes.
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 Atlas Automated Urine Chemistry Analyzer (k932674)
Related Devices
- K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT · Iris International Inc., A Division of Iris Iris I · Mar 23, 2011
- K063390 — URINE CHEMISTRY ANALYZER UR-50 · Ind Diagnostic, Inc. · Mar 1, 2007
- K051526 — URITEK-720+ URINE ANALYZER · Teco Diagnostics · Aug 16, 2005
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k140717
B. Purpose for Submission:
New device
C. Measurand:
Urine bilirubin, blood, glucose, protein, ketone, leukocytes, nitrite, pH, urobilinogen, and specific gravity, color, and clarity.
D. Type of Test:
Qualitative and semi-quantitative urinalysis
E. Applicant:
Siemens Healthcare Diagnostics
F. Proprietary and Established Names:
CLINITEK Novus Automated Urine Chemistry Analyzer
CLINITEK Novus 10 Urinalysis Cassette
CLINITEK Novus Calibration Kit
G. Regulatory Information:
| Regulation Description | Product Code | Device Class | Regulation |
| --- | --- | --- | --- |
| Occult blood test | JIO | II | 21 CFR § 864.6550 |
| Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR § 862.1340 |
| Urinary protein (non-quantitative) test system | JIR | I | 21 CFR § 862.1645 |
| 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 |
| Leukocyte peroxidase test | LJX | I | 21 CFR § 864.7675 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR § 862.1510 |
| Urinary pH (non-quantitative) test system | CEN | I | 21 CFR § 862.1550 |
| Refractometer for clinical use (specific | JRE | I | 21 CFR § 862.2800 |
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| gravity) | | | |
| --- | --- | --- | --- |
| Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR § 862.1785 |
| Automated urinalysis system | KQO | I | 21 CFR § 862.2900 |
| Calibrator | JIX | II | 21 CFR § 862.1150 |
Panel- Chemistry (75), (81) Hematology
## H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The CLINITEK Novus Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus 10 Urinalysis Cassette is intended for the semi-quantitative measurement of the following parameters in urine: bilirubin, blood (occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein, color, and urobilinogen.
These measurements are used to assist diagnosis in the following areas:
- Carbohydrate metabolism (such as diabetes mellitus)
- Kidney function
- Liver function
- Metabolic disorders
- Urinary tract infection
For in vitro diagnostic use.
The CLINITEK Novus Calibration Kit is intended to be used with the CLINITEK Novus Urinalysis Cassette to calibrate the CLINITEK Novus Automated Urine Chemistry analyzer. This product is for professional in vitro diagnostic use.
3. Special conditions for use statement(s):
For prescription use only in central clinical laboratory settings.
4. Special instrument requirements:
CLINITEK Novus Automated Urine Chemistry Analyzer
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I. Device Description:
The CLINITEK Novus system is a fully automated urine chemistry analyzer that is designed for use with the CLINITEK Novus 10 Urinalysis Cassette which contains reagent test pads organized in strips on a test card format. The system measures urine Bilirubin, Blood, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, and Urobilinogen, Specific Gravity, Color, and Clarity. The CLINITEK Novus system is a batch urine analyzer that can test up to 20 sample racks of 10 samples each. The system also has STAT testing capabilities. Sample identification is accomplished using appropriately barcoded tubes and an internal barcode reader. The sampling mechanism pipettes a small quantity of urine onto each test pad of the test card and onto the SG sensor for the measurement of specific gravity and clarity. Rinse cycles are automatically performed between each patient sample. Reflectance measurements from the sampled pads are converted to results that are displayed on the instrument, or may be sent to a printer or laboratory information system (LIS). The Novus reports qualitative and semi-quantitative values for the test pad parameters and uses a refractometer to measure specific gravity.
The calibration process uses a 3-point calibration, including baseline adjustments for each test pad, clarity, and the SG measurement. The CLINITEK Novus Calibration Kit contains four solutions that are used for calibrating the SG sensor, clarity, and reflectance. The system also performs a cleaning cycle and dry pad calibration.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Siemens Healthcare Diagnostics CLINITEK Atlas Automated Urine Chemistry Analyzer
2. Predicate 510(k) number(s):
k932674
3. Comparison with predicate:
Analyzer and Cassette
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device
CLINITEK Novus | Predicate Device
CLINITEK Atlas
(k932764) |
| Intended Use | Automated urine chemistry analyzer intended for professional in vitro diagnostic use in clinical laboratories. The analyzer is intended for the measurement of the following components in urine: bilirubin, blood | Same |
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| Differences | | |
| --- | --- | --- |
| Item | Candidate Device CLINITEK Novus | Predicate Device CLINITEK Atlas (k932764) |
| Instrument Optical System | Two pairs of LEDs illuminate the test pads and a camera in the analyzer electronically analyzes the color and intensity of the light reflected from the reacted test pads. | Reflectance photometer consisting of halogen lamp, fiber optics and lens and detector. Light travels onto a lens where it is focused onto the detector and the intensity is converted into electrical impulses to generate clinically meaningful units. |
| Reagent Format | Cassette contains reagent test pads organized in strips on a test card format. | Roll containing reagent strips. |
| Quality Check | Conducts a quality check to assess if the test pad has been exposed to high humidity. | None |
| Cleaning cycle | Includes a cleaning cycle before calibration | Does not include a cleaning cycle before calibration |
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Calibrators
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate Device
CLINITEK Novus
Calibration Kit | Predicate Device
CLINITEK Atlas Calibration Kit
(k932764) |
| Intended Use | In vitro diagnostic product for the calibration of CLINITEK Automated Urine Chemistry Analyzer | Same |
| Preparation | Ready to use | Same |
| Matrix | Liquid | Same |
| Number of calibrators | Four: Calibrator #1, #2, #3, and #4 | Same |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline, Second Edition.
L. Test Principle:
The CLINITEK Novus analyzer utilizes an optical system that has a complementary metal oxide semiconductor (CMOS) digital imager. The concentration of each analyte is measured by the color change that develops when a sample is deposited on a test pad. The imager records the color and intensity of the light reflected off the reacted test pads, which are illuminated by two pairs of LED lights. The optical system converts this data into measured values for the analytes.
Specific gravity is determined by the fiber optic refractive index method. The SG sensor measures the amount of light passing through the fiber optic at one end. Because the refractive index is proportional to specific gravity, the light measured correlates to the specific gravity of the sample yielding a quantitative result. To determine urine clarity, light is projected into the sample via a series of optical fibers. The quantities of transmitted and scattered light are correlated to the clarity of the sample.
A chemical reaction between the analytes in the urine and each test pad on the CLINITEK Novus 10 Urinalysis Cassette causes a change in color that is used to determine the concentration of the following urine analytes: bilirubin, blood, glucose, leukocytes, nitrite, pH, protein, color and urobilinogen. The chemical reactions are described below:
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| Analyte | Test Principle |
| --- | --- |
| Bilirubin | Based on the coupling of bilirubin with diazotized dichloroaniline in a strongly acid medium. |
| Blood | Based on the peroxidase-like activity of hemoglobin, which catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3’,5,5’-tetramethylbenzidine. |
| Glucose | Based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the oxidative coupling of 4-amino-antipyrine and 4-methylcatechol by hydrogen peroxide. |
| Ketone | Based on the reaction of nitroprusside with acetoacetic acid. |
| Leukocytes | Granulocytic leukocytes contain esterases that catalyze the hydrolysis of the derivatized pyrrole amino acid ester to liberate 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt. |
| Nitrite | Based upon the conversion of nitrate (derived from the diet) to nitrite by the action of Gram negative bacteria in the urine. At the acid pH of the test area, nitrite in the urine reacts with ρ-arsanilic acid to form a diazonium compound. This diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h)quinolin-3-ol. |
| pH | Based on a double indicator principle that gives a broad range of colors covering the entire urinary pH range. |
| Protein | Based on the protein-error-of-indicators principle. At a constant pH, the presence of protein causes a change in the color of the indicator. |
| Urobilinogen | Based on the Ehrlich reaction in which ρ-diethylaminobenzaldehyde in conjunction with a color enhancer reacts with urobilinogen in a strongly acid medium. |
| Color | Color is determined by comparing a specific non-reactive test pad to the same pad wetted with the urine sample. The reflectance of the wet pad is compared to the reflectance of the dry pad. |
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision was evaluated at one site using three CLINITEK Novus analyzers and a single lot of Novus Cassettes for ten days, two runs each day, two replicates per run, on each of the three analyzers for each sample (N = 120). Test samples consisted of three commercially available urinalysis controls: a negative control, a low-mid positive control, and a high-positive control. The two positive controls were diluted and spiked in order to cover the test pad measuring range of each analyte. The targeted output blocks are shown below:
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| Test Analyte | Control Limits | | |
| --- | --- | --- | --- |
| | Negative Control | Low-Mid Positive Control | High Positive Control |
| Bilirubin | Negative | Moderate | Large |
| Blood | Negative | Trace | Large |
| Glucose | Negative | 100 mg/dL | 1000 mg/dL |
| Ketone | Negative | 15 mg/dL | 80 mg/dL |
| Leukocyte | Negative | Small | Large |
| Nitrite | Negative | Positive | Positive |
| pH | ≤6.5 | 7.0-8.0 | >9.0 |
| Protein | Negative | 30 mg/dL | 300 mg/dL |
| SG | ≤1.005 | 1.006 – 1.019 | ≥1.020 |
| Urobilinogen | < 1 mg/dL | 2 mg/dL | 4 mg/dL |
The results of the precision study are summarized in the tables below:
Percent Agreement for Negative Control
| Analyte | Control Limits | Exact Block Agreement (%) | Agreement within ±1 Block (%) |
| --- | --- | --- | --- |
| Bilirubin | Negative | 120/120 (100%) | 120/120 (100%) |
| Blood | Negative | 119/120 (99.2%) | 120/120 (100%) |
| Glucose | Negative | 120/120 (100%) | 120/120 (100%) |
| Ketone | Negative | 120/120 (100%) | 120/120 (100%) |
| Leukocyte | Negative | 120/120 (100%) | 120/120 (100%) |
| Nitrite | Negative | 120/120 (100%) | 120/120 (100%) |
| pH | < 6.5 | 120/120 (100%) | 120/120 (100%) |
| Protein | Negative | 120/120 (100%) | 120/120 (100%) |
| SG | < 1.005 | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | < 1 mg/dL | 114/120 (95%) | 120/120 (100%) |
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Percent Agreement for Low Positive Control:
| Analyte | Control Limits | Exact Block Agreement (%) | Agreement within ±1 Block (%) |
| --- | --- | --- | --- |
| Bilirubin | Moderate | 120/120 (100%) | 120/120 (100%) |
| Blood | Trace | 120/120 (100%) | 120/120 (100%) |
| Glucose | 100 mg/dL | 119/120 (99.2%) | 120/120 (100%) |
| Ketone | 15 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Leukocyte | Small | 109/120 (90.8%) | 120/120 (100%) |
| pH | 7.0-8.0 | 120/120 (100%) | 120/120 (100%) |
| Protein | 30 mg/dL | 120/120 (100%) | 120/120 (100%) |
| SG | 1.006 – 1.019 | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | 2 mg/dL | 120/120 (100%) | 120/120 (100%) |
Percent Agreement for High Positive Control
| Analyte | Control Limits | Exact Block Agreement (%) | Agreement within ±1 Block (%) |
| --- | --- | --- | --- |
| Bilirubin | Large | 120/120 (100%) | 120/120 (100%) |
| Blood | Large | 120/120 (100%) | 120/120 (100%) |
| Glucose | 1000 mg/dL | 117/120 (97.5%) | 120/120 (100%) |
| Ketone | 80 mg/dL | 108/120 (90%) | 120/120 (100%) |
| Leukocyte | Large | 120/120 (100%) | 120/120 (100%) |
| Nitrite | Positive | 120/120 (100%) | 120/120 (100%) |
| pH | >9.0 | 120/120 (100%) | 120/120 (100%) |
| Protein | 300 mg/dL | 120/120 (100%) | 120/120 (100%) |
| SG | >/= 1.020 | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | 4 mg/dL | 115/120 (95.8%) | 120/120 (100%) |
b. Linearity/assay reportable range:
The percent recovery for each analyte was evaluated using a negative urine pool that was spiked with known concentrations of each analyte at each color block increment on the Novus 10 Cassette. Leukocytes were tested in low specific gravity urine (< 1.015) as well as in a buffer with a high specific gravity (1.016 – 1.021) because leukocytes are not stable in contrived urine samples with high specific gravity (>1.015). All samples were tested on an FDA cleared urine analyzer to confirm the
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expected analyte concentration of the test samples. Each sample was tested in replicates of 12 using three CLINITEK Novus analyzers and one Novus Cassette lot on three separate days (N=108). Nitrite was excluded from the study because it only yields a negative and positive result. Nitrite positive and negative cutoffs are evaluated in the sensitivity study below. Recovery was calculated using the Novus results compared to the expected results for each of the known concentrations for each color block. The formula used was:
# of clinical block outputs that match the expected value of the sample tested X 100
Total number of samples tested at the expected value
Results were as follows:
| Analyte | Block Output | Concentration tested | %Exact Match |
| --- | --- | --- | --- |
| Bilirubin | Negative | 0 mg/dL | 100% (108/108) |
| | Small | 0.75 mg/dL | 100% (108/108) |
| | Moderate | 1.5 mg/dL | 98.2% (106/108) |
| | Large | 5 mg/dL | 100% (108/108) |
| Blood | Negative | 0 mg/dL | 100% (109/109) |
| | Trace | 0.026 mg/dL | 79.6% (86/108) |
| | Small | 0.065 mg/dL | 97.3% (106/109) |
| | Moderate | 0.160 mg/dL | 100% (109/109) |
| | Large | 0.400 mg/dL | 93.5% (108/108) |
| Glucose | Negative | 0 mg/dL | 100% (108/108) |
| | 100 mg/dL | 50 mg/dL | 100% (108/108) |
| | 250 mg/dL | 140 mg/dL | 100% (108/108) |
| | 500 mg/dL | 390 mg/dL | 100% (108/108) |
| | 1000 mg/dL | 1125 mg/dL | 99.1% (107/108) |
| Ketone | Negative | 0 mg/dL | 100% (108/108) |
| | Trace | 6.3 mg/dL | 100% (108/108) |
| | 40 mg/dL | 43.8 mg/dL | 100% (108/108) |
| | 80 mg/dL | 90 mg/dL | 100% (108/108) |
| | 160 mg/dL | 190 mg/dL | 98.9% (89/90) |
| pH | 5.0 | 5.0 | 98.2% (106/108) |
| | 5.5 | 5.5 | 98.2% (106/108) |
| | 6.0 | 5.9 | 98.2% (106/108) |
| | 6.5 | 6.4 | 98.1% (105/107) |
| | 7.0 | 6.9 | 98.1% (106/107) |
| | 7.5 | 7.5 | 98.1% (106/107) |
| | 8.0 | 8.0 | 97.2% (104/107) |
| | 8.5 | 8.5 | 95.3% (102/107) |
| | >9.0 | 9.5 | 98.1% (104/106) |
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| Analyte | Block Output | Concentration tested | %Exact Match |
| --- | --- | --- | --- |
| Protein | Negative | 0 mg/dL | 100% (108/108) |
| | Trace | 16 mg/dL | 100% (108/108) |
| | 30 mg/dL | 33 mg/dL | 98.2% (106/108) |
| | 100 mg/dL | 95 mg/dL | 98.2% (106/108) |
| | 300 mg/dL | 375 mg/dL | 98.2% (106/108) |
| | 1000 mg/dL | 1500 mg/dL | 99.1% (106/107) |
| Urobilinogen | 0.2 mg/dL | 0 mg/dL | 100% (108/108) |
| | 1 mg/dL | 1.1 mg/dL | 100% (108/108) |
| | 2 mg/dL | 2.3 mg/dL | 99.1% (106/107) |
| | 4 mg/dL | 4.5 mg/dL | 90.7% (97/107) |
| | 8 mg/dL | 9 mg/dL | 100% (107/107) |
| Leukocyte (Low/Med SG Urine) (≤ 1.015) | Negative | 0 cells/μL | 100% (108/108) |
| | Trace | 12 cells/μL | 97.2% (105/108) |
| | Small | 22 cells/μL | 88.9% (96/108) |
| | Moderate | 40 cells/μL | 99.1% (107/108) |
| | Large | 100 cells/μL | 100% (108/108) |
| Leukocyte (High SG Buffer) 1.016-1.021 | Negative | 0 cells/μL | 100% (108/108) |
| | Trace | 5 cells/μL | 71.3% (77/108) |
| | Small | 12 cells/μL | 98.2% (106/108) |
| | Moderate | 30 cells/μL | 99.1% (107/108) |
| | Large | 70 cells/μL | 83.0% (83/100) |
Specific Gravity: Specific gravity linearity was evaluated across the physiological range, 1.000-1.050, by performing a correlation analysis. Forty-four clinical samples were measured on the CLINITEK Novus and on a refractometer and the results were analyzed by linear and Deming regression. The results are summarized below:
| SG Linearity | Slope | Intercept | r-squared |
| --- | --- | --- | --- |
| Linear Regression | 1.09 | -0.0951 | 0.995 |
| Deming Regression | 1.098 | -0.098 | N/A |
The linearity study has demonstrated that the device is able to detect the claimed measuring range stated in the below chart for each of the analytes.
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| Analyte | CLINITEK Novus Output Block | Measuring Range |
| --- | --- | --- |
| Bilirubin | Negative | 0.0 - 0.5 mg/dL |
| | Small | 0.5 - 1.20 mg/dL |
| | Moderate | 1.20 - 2.70 mg/dL |
| | Large | > 2.70 mg/dL |
| Blood | Negative | 0.0 - 0.013 mg/dL |
| | Trace | 0.013 - 0.026 mg/dL |
| | Small | 0.026 - 0.072 mg/dL |
| | Moderate | 0.072 - 0.3 mg/dL |
| | Large | > 0.3 mg/dL |
| Glucose | Negative | 0.0 - 36.0 mg/dL |
| | 100 mg/dL | 36.0 - 110 mg/dL |
| | 250 mg/dL | 110 - 276 mg/dL |
| | 500 mg/dL | 276 - 820 mg/dL |
| | 1000 mg/dL | > 820 mg/dL |
| Ketone | Negative | 0.0 - 3.60 mg/dL |
| | Trace | 3.60 - 9.0 mg/dL |
| | 15 mg/dL | 9.0 - 35 mg/dL |
| | 40 mg/dL | 35 - 77 mg/dL |
| | 80 mg/dL | 77 - 156 mg/dL |
| | 160 mg/dL | > 156 mg/dL |
| Leukocytes | Negative | 0.0 - 6.0 cells/uL |
| | Trace | 6.0 - 10.8 cells/uL |
| | Small | 10.8 - 24.2 cells/uL |
| | Moderate | 24.2 - 91 cells/uL |
| | Large | > 91 cells/uL |
| Nitrite | Negative | 0.0 - 0.06 mg/dL |
| | Positive | > 0.06 mg/dL |
| pH | 5 | < 5.3 |
| | 5.5 | 5.3 - 5.7 |
| | 6 | 5.7 - 6.1 |
| | 6.5 | 6.1 - 6.6 |
| | 7 | 6.6 - 7.1 |
| | 7.5 | 7.1 - 7.7 |
| | 8 | 7.7 - 8.3 |
| | 8.5 | 8.3 - 8.7 |
| | 9 | > 8.7 |
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| Protein | Negative | 0.0 - 10.8 mg/dL |
| --- | --- | --- |
| | Trace | 10.8 - 18.0 mg/dL |
| | 30 mg/dL | 18.0 - 43.2 mg/dL |
| | 100 mg/dL | 43.2 - 140 mg/dL |
| | 300 mg/dL | 140 - 1000 mg/dL |
| | 1000 mg/dL | > 1000 mg/dL |
| Urobilinogen | 0.2 mg/dL | 0.0 - 0.24 mg/dL |
| | 1 mg/dL | 0.24 - 1.90 mg/dL |
| | 2 mg/dL | 1.90 - 3.9 mg/dL |
| | 4 mg/dL | 3.9 - 6.24 mg/dL |
| | 8 mg/dL | > 6.24 mg/dL |
| SG | N/A | 1.000-1.099 |
c. Traceability, Stability, Expected values (controls, calibrators, or meth
Traceability:
The CLINITEK Novus Calibrators have been tested using materials or calibrated devices which are traceable to the National Institute of Standards and Technology in conformance with standard EN ISO 17511:2001
Value assignment:
The CLINITEK Novus Calibrators are prepared to achieve the targeted analyte values listed below. The calibrators have fixed values which are not lot specific. Siemens Healthcare performs a value and performance assessment and the calibrators must meet internal specifications before release. The expected values for CLINITEK Novus Calibrators 1-4 are summarized below. Calibrators not utilized for a particular reagent on the CLINITEK Novus are noted as not applicable.
| Reagent | Expected Value by CLINITEK Novus Calibrator | | | |
| --- | --- | --- | --- | --- |
| | CAL 1 | CAL 2 | CAL 3 | CAL 4 |
| Bilirubin | Negative | NA | NA | NA |
| Glucose | NA | Negative | ≥ 1000mg/dL | NA |
| Ketone | NA | Negative | NA | NA |
| Leukocytes | NA | NA | Negative | NA |
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| Blood | NA | Negative | NA | NA |
| --- | --- | --- | --- | --- |
| Nitrite | Negative | NA | NA | NA |
| pH | 6.4-7.0 | 4.5-6.5 | 6.0-6.3 | NA |
| Protein | Negative | NA | ≥ 300mg/dL | NA |
| SG | 1.004-1.008 | 1.04-1.05 | 1.020-1.026 | NA |
| Urobilinogen | NA | 0.2 mg/dL | NA | NA |
| Color | Yellow | Yellow | Yellow | NA |
| Clarity | NA | NA | NA | Turbid Abs 0.177-0.235 |
Stability:
The shelf-life and open-vial stability and storage study protocols and acceptance criteria were reviewed and found to be adequate for the CLINITEK Novus 10 Urinalysis Cassettes and the CLINITEK Novus Calibrator Kit. The stability studies support the following sponsor's stability claims:
CLINITEK Novus 10 Urinalysis Cassettes:
Shelf-life Stability: The CLINITEK Novus 10 Urinalysis Cassettes are stable for 52 weeks when stored at temperatures between 16° C and 30° C.
Onboard Stability: The CLINITEK Novus 10 Urinalysis Cassettes are stable up to 14 days when opened and in use on the analyzer.
CLINITEK Novus Calibrator Kit:
Shelf-life claims: Un-opened calibrators can be stored at 2-8°C until the expiration date or for 18 months.
Open-vial claims: The recommended storage condition for in-use calibrators is 2-8 °C and is stable for 18 months after opening. Labeling indicates not to freeze the calibrator materials.
Controls: The sponsor recommends the use of the CLINITEK Atlas Urine Controls, previously cleared in k923674, for use on the CLINITEK Novus analyzer or other commercially available urinalysis controls.
d. Detection limit:
The sponsor performed a color block cutoff study to evaluate the performance at each color block for each analyte on the Novus 10 Urinalysis Cassettes. Urine samples for
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each analyte were prepared by spiking a negative urine pool with a minimum of 5 sample concentrations of each analyte across the measuring range for each test pad. The samples were tested on three CLINITEK Novus analyzers with two different lots of Novus 10 Urinalysis Cassettes. The cutoff concentration for each color block was defined as the lowest sample concentration at which $>55\%$ of the test results are positive for each color block.
The results are presented in the table below.
| Analyte | Block Output | Block Cut-off Concentration | % Positive Results at the Cutoff Concentration |
| --- | --- | --- | --- |
| Bilirubin | Small | 0.5 mg/dL | 56% |
| | Moderate | 1.20 mg/dL | 94% |
| | Large | 2.70 mg/dL | 100% |
| Blood | Trace | 0.013 mg/dL | 100% |
| | Small | 0.026 mg/dL | 56% |
| | Moderate | 0.072 mg/dL | 83% |
| | Large | 0.300 mg/dL | 89% |
| Glucose | 100 mg/dL | 36 mg/dL | 89% |
| | 250 mg/dL | 110 mg/dL | 78% |
| | 500 mg/dL | 276 mg/dL | 94% |
| | 1000 mg/dL | 820 mg/dL | 89% |
| Ketone | Trace | 3.60 mg/dL | 89% |
| | 15 mg/dL | 9.0 mg/dL | 56% |
| | 40 mg/dL | 35 mg/dL | 100% |
| | 80 mg/dL | 77 mg/dL | 94% |
| | 160 mg/dL | 156 mg/dL | 56% |
| Leukocyte | Trace | 6.0 cells/mcL | 72% |
| | Small | 10.8 cells/mcL | 72% |
| | Moderate | 22.0 cells/mcL | 89% |
| | Large | 63 cells/mcL | 56% |
| Nitrite | Positive | 0.06 mg/dL | 78% |
| pH | 5.0 | 5.0 | 100% |
| | 5.5 | 5.3 | 56% |
| | 6.0 | 5.7 | 78% |
| | 6.5 | 6.1 | 100% |
| | 7.0 | 6.6 | 100% |
| | 7.5 | 7.1 | 94% |
| | 8.0 | 7.7 | 61% |
| | 8.5 | 8.3 | 72% |
| | >9.0 | 8.7 | 61% |
| | Trace | 10.8 mg/dL | 78% |
| | 30 mg/dL | 18.0 mg/dL | 72% |
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| Protein | 100 mg/dL | 43.2 mg/dL | 94% |
| --- | --- | --- | --- |
| | 300 mg/dL | 140 mg/dL | 67% |
| | 1000 mg/dL | 1000 mg/dL | 56% |
| Urobilogen | 1 mg/dL | 0.24 mg/dL | 61% |
| | 2 mg/dL | 1.90 mg/dL | 100% |
| | 4 mg/dL | 3.9 mg/dL | 61% |
| | 8 mg/dL | 6.2 mg/dL | 56% |
e. Analytical specificity:
Interfering substance studies were performed to evaluate the effect of potential interferents on test results of the urine chemistry test strips. Testing was performed using two human urine samples with analyte concentrations of negative and low positive, respectively, and spiked with interferents. Samples were tested in replicates of 12, and interference was defined as a change in output of $\pm 1$ color block in comparison to the unspiked control sample. For pH, interference was defined as a change of $\pm 2$ color blocks between the spiked and unspiked control sample.
The substances tested at the highest concentration listed below did not interfere with the measurement of any of the CLINITEK Novus analytes:
| Substance tested | Highest concentration of substance tested which demonstrated no interference. |
| --- | --- |
| Acetaminophen | 40 mg/dL |
| Ammonium Chloride | 200 mg/dL |
| Cefoxitin | 66 mg/dL |
| Cephalosporin | 80 mg/dL |
| Citric Acid | 80 mg/dL |
| Galactose | 20 mg/dL |
| Gentamicin Sulfate | 6 mg/dL |
| Glycine | 400 mg/dL |
| Glyburide | 15 ug/mL |
| Hemoglobin | 5 mg/dL |
| Imipenem | 100 mg/dL |
| Indican | 50 mg/dL |
| Keflex | 150 mg/dL |
| Keflin | 50 mg/dL |
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The following table shows the substances which did interfere with one or more of the Novus analytes. Results are expressed as the lowest concentration of interfering substance that exhibited interference and the resulting change in output of colorblock:
| Analyte | Concentration of Substance at which Interference was observed | Change in Color block Output |
| --- | --- | --- |
| Bilirubin | Acetylcysteine ≥ 135 mg/dL, Ascorbic Acid ≥ 25 mg/dL, Citric acid ≥ 40 mg/dL, Curcuma ≥ 75 mg/dL, Hypochlorite ≥1.3%, MESNA ≥ 20 mg/dL | -1 |
| Blood | Acetylcysteine ≥ 67.5 mg/dL, Ascorbic Acid ≥ 25 mg/dL, Formalin ≥ 185 mg/dL, Captopril ≥ 12.5 mg/dL, Clorhexidine ≥ 113 mg/dL, Chloroquine ≥ 40 mg/dL, MESNA ≥ 20 mg/dL, Levodopa ≥ 19 mg/dL, Curcuma 75 mg/dL | -1 |
| | Hypochlorite ≥ 0.7%, Microbial peroxidase | +1 |
| Glucose | Acetylcysteine ≥ 67.5 mg/dL, Ascorbic Acid ≥ 25 mg/dL, MESNA ≥ 20 mg/dL | -1 |
| | Hypochlorite ≥ 1.3% | +1 |
| Ketone | Boric Acid ≥ 500 mg/dL, Formalin ≥ 93 mg/dL, Hypochlorite ≥ 1.3% | -1 |
| | Acetylcysteine ≥ 67.5 mg/dL, Captopril ≥ 12.5 mg/dL, MESNA ≥ 20 mg/dL, Curcuma ≥ 75 mg/dL, Hydrochlorothiazide ≥ 150 mg/dL, Imipenem ≥ 50 mg/dL, Levadopa ≥ 56 mg/dL | +1 |
| Leukocyte | Calcium Chloride ≥ 100 mg/dL, Boric Acid ≥ 500 | -1 |
| | Hypochlorite ≥ 0.7%, Microbial peroxidase | |
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| | mg/dL, Glucose ≥ 1250 mg/dL, Chloroquine ≥ 20 mg/dL, Clorhexidine ≥37.5 mg/dL, Curcuma≥ 75 mg/dL hypochlorite ≥ 0.7%, Urine specific gravity >1.015* | |
| --- | --- | --- |
| | Formalin ≥ 93 mg/dL, Curcuma ≥ 75 mg/dL | +1 |
| Nitrite | Ascorbic Acid ≥ 100 mg/dL, Lodine ≥ 100 mg/dL, Formalin ≥ 185mg/dL, Oxalic Acid ≥ 75 mg/dL | -1 |
| | Curcuma ≥ 75 mg/dL, Riboflavin ≥ 30 mg/dL, Pyridium ≥ 50 mg/dL | +1 |
| Protein | | |
| | Chlorhexidine ≥ 38 mg/dL, Chloroquine ≥ 20 mg/dL, Pyridium ≥ 150 mg/dL | +1 |
| Urobilinogen | Acetylcysteine ≥ 67.5mg/dL, Captopril ≥ 25 mg/dL, Chlorhexidine ≥75 mg/dL, Formalin ≥ 93 mg/dL, Hypochlorite ≥0.7%, Glucose ≥ 2500 mg/dL, Hydrochlorothiazide ≥ 6 mg/dL, Lactose ≥ 20 mg/dL, Meropenem ≥ 100 mg/dL, P-aminosalicylic acid ≥ 62.5 mg/dL, MESNA ≥ 20 mg/dL, Tagamet ≥ 5 g/dL, Sulfamethoxazole ≥ 17.5 mg/dL | -1 |
| | Pyridium ≥ 100 mg/dL, Curcuma ≥ 75 mg/dL | +1 |
| pH | No negative or positive interference was observed from the substances tested. | - |
*The high specific gravity of a sample acts by inhibiting the color development of the leukocyte reagent by decreasing the activity of the esterase from leukocyte cells. The CLINITEK Novus uses an algorithm intended to partially compensate for the negative impact a high specific gravity sample has on the color development.
pH Interference:
Urine samples were evaluated at increased pH of $>9.0$ . Alkaline urine with a pH value of $>9.0$ did not demonstrate interfering effects on any of the test analytes.
Specific Gravity interference:
Literature was cited for known interferents with specific gravity (SG) test results. The labeling states the following: Measurement of specific gravity by refractometry may be influenced by high levels of urinary glucose and protein which can cause under-estimation of the actual specific gravity.
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Carryover:
Carryover studies were performed to assess the amount of sample carried over by the CLINITEK Novus analyzer from one specimen reaction into subsequent specimen reactions. Results of the carryover testing for the urine chemistry analytes demonstrated no detectable carryover by the CLINITEK Novus analyzer.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
Patient urine samples were collected and evaluated at three clinical sites comparing the results from the CLINITEK Novus to the CLINITEK Atlas. A total of 2773 specimens consisting of fresh, refrigerated, and frozen samples were analyzed on the candidate and predicate devices for the following analytes: bilirubin, blood, creatinine, glucose, ketone, leukocytes, nitrite, pH, urobilinogen and specific gravity. The results for overall percent agreement and within one level agreement are summarized in the tables below.
| | LEU | CLINITEK Atlas | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Neg | Trace | Small | Mod | Large |
| CLINITEK Novus | Neg | 1600 | 5 | 1 | | |
| | Trace | 79 | 80 | 13 | | |
| | Small | 1 | 10 | 129 | 3 | |
| | Mod | | | 16 | 85 | 5 |
| | Large | | | | 6 | 157 |
| Total | | 1680 | 95 | 159 | 94 | 162 |
| % Agreement (exact match) | | 95.0% | 85.7% | 81.1% | 90.4% | 96.6% |
| % Agreement (±1 color block) | | 99.9% | 100% | 99.7% | 100% | 100% |
| | NIT | CLINITEK Atlas | |
| --- | --- | --- | --- |
| | | Negative | Positive |
| CLINITEK Novus | Negative | 1707 | 0 |
| | Positive | 12 | 399 |
| Total | | 1719 | 399 |
| % Agreement (exact match) | | 99.3% | 100% |
| % Agreement (±1 color block) | | 100% | 100% |
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| | Ketone mg/dl | CLINITEK Atlas | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Neg | Trace | 15 | 40 | 80 | 160 |
| CLINITEK Novus | Neg | 1670 | 14 | | 1* | | |
| | Trace | 2 | 158 | 9 | | | |
| | 15 | | 2 | 82 | 6 | | |
| | 40 | | | 2 | 117 | 1 | |
| | 80 | | | | | 66 | |
| | 160 | | | | | 5 | 28 |
| Total | | 1672 | 174 | 93 | 124 | 72 | 28 |
| % Agreement (exact match) | | 99.9 % | 90.8% | 88.2% | 94.4% | 91.7% | 100% |
| % Agreement (±1 color block) | | 100% | 100% | 100% | 99.2% | 100% | 100% |
*This false negative result was due to color interference caused by high hemoglobin content in sample.
| | BLD | CLINITEK Atlas | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Negative | Trace | Small | Moderate | Large |
| CLINITEK Novus | Negative | 1498 | 4 | 1 | | |
| | Trace | 34 | 97 | 12 | | |
| | Small | 1 | 18 | 127 | 10 | |
| | Moderate | | | 5 | 125 | 14 |
| | Large | | | | 1 | 204 |
| Total | | 1523 | 119 | 145 | 136 | 218 |
| % Agreement (exact match) | | 97.8% | 81.5% | 87.6% | 91.9% | 93.6% |
| % Agreement (±1 color block) | | 100% | 100.0% | 99.7% | 100% | 100% |
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To evaluate the performance of the CLINITEK Novus system given the difference in some results (below) compared to the predicate device, 1033 of the samples from the method comparison study were also tested using the Ictotest, an alternative qualitative method for bilirubin in urine. The Ictotest has a single cutoff of approximately $0.05\mathrm{mg / dL}$ .
| | BIL | CLINITEK Atlas | | | |
| --- | --- | --- | --- | --- | --- |
| | | Negative | Small | Moderate | Large |
| CLINITEK Novus | Negative | 2234 | 1041 | 12 | 13 |
| | Small | 55 | 190 | 15 | 14 |
| | Moderate | | 1 | 112 | 7 |
| | Large | | | | 102 |
| Total | | 2239 | 295 | 128 | 111 |
| % Agreement (exact match) | | 99.8% | 64.4% | 87.5% | 91.9% |
| % Agreement (±1 color block) | | 100.0% | 100.0% | 99.2% | 98.2% |
${}^{1}$ 93 of the 104 samples in this category were negative by the Ictotest.
2 This sample was positive by the Ictotest.
3 This sample was negative by the Ictotest.
4 This sample was negative by the Ictotest.
5 3 of 5 samples were tests by Ictotest. All 3 samples tested were negative by the Ictotest.
| | URO mg/dL | CLINITEK Atlas | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0.2 mg/dL | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8 mg/dL |
| CLINITEK Novus | 0.2 mg/dL | 1982 | 53 | | | |
| | 1 mg/dL | 2 | 327 | 15 | | |
| | 2 mg/dL | | 2 | 209 | 10 | |
| | 4 mg/dL | | | 5 | 116 | 3 |
| | 8 mg/dL | | | | 4 | 45 |
| Total | | 1984 | 382 | 229 | 130 | 48 |
| % Agreement (exact match) | | 99.9% | 85.6% | 91.3% | 89.2% | 93.8% |
| % Agreement (±1 color block) | | 100% | 100% | 100% | 100% | 100% |
An additional urobilinogen method comparison study was performed at a fourth site using 261 specimens. Results are summarized in the following table.
| | URO mg/dL | CLINITEK Atlas | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0.2 mg/dL | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8 mg/dL |
| | 0.2 mg/dL | 187 | | | | |
| | 1 mg/dL | | 46 | | | |
| | 2 mg/dL | | | 10 | | |
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| | 4 mg/dL | | | | 12 | 4 |
| --- | --- | --- | --- | --- | --- | --- |
| | 8 mg/dL | | | | | 4 |
| Total | | 187 | 48 | 10 | 12 | 4 |
| % Agreement (exact match) | | 100% | 95.8% | 100% | 100% | 100% |
| % Agreement (±1 color block) | | 100% | 100% | 100% | 100% | 100% |
| | | CLINITEK Atlas | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | PRO mg/dL | Neg | 15 mg/dL | 30 mg/dL | 100 mg/dL | 300 mg/dL | 1000 mg/dL |
| | Negative | 1511 | 2 | | | | |
| CLINITEK Novus | 15 mg/dL | 24 | 207 | 4 | | | |
| | 30 mg/dL | | 20 | 184 | 3 | | |
| | 100 mg/dL | 1 | | 7 | 145 | 1 | |
| | 300 mg/dL | | | | 7 | 77 | 8 |
| | 1000 mg/dL | | | | | | 71 |
| Total | | 1536 | 229 | 195 | 155 | 78 | 79 |
| % Agreement (exact match) | | 98.4% | 90.4% | 94.4% | 93.3% | 98.7% | 89.9% |
| % Agreement (±1 color block) | | 99.9% | 100% | 100% | 100% | 100% | 100% |
| | GLU mg/dL | CLINITEK Atlas | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Negative | 100 | 250 | 500 | 1000 |
| CLINITEK Novus | Negative | 1563 | | | | |
| | 100 | 7 | 147 | | | |
| | 250 | | 19 | 95 | | |
| | 500 | | | 8 | 88 | 4 |
| | 1000 | | | | 4 | 183 |
| Total | | 1570 | 166 | 103 | 92 | 187 |
| % Agreement (exact match) | | 99.6% | 88.5% | 92.2% | 95.7% | 97.9% |
| % Agreement (±1 color block) | | 100% | 100% | 100% | 100% | 100% |
| | pH | CLINITEK Atlas | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| CLINITEK Novus | 5.0 | 85 | 121 | | | | | | |
| | 5.5 | 1 | 203 | 213 | | | | | |
| | 6.0 | | 1 | 426 | 19 | | | | |
| | 6.5 | | | 26 | 399 | 10 | | | |
| | 7.0 | | | | 33 | 376 | 2 | | |
| | 7.5 | | | | | 106 | 178 | | |
| | 8.0 | | | 1 | | | 64 | 44 | 1 |
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| | 8.5 | | | | | | 1 | 51 | 49 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | >9.0 | | | | | | | 2 | 361 |
| Total | | 86 | 325 | 666 | 451 | 492 | 245 | 97 | 411 |
| % Agreement(exact match) | | 98.8% | 62.5% | 64.0% | 88.5% | 76.4% | 72.7% | 45.4% | 99.8% |
| % Agreement(±1 color block) | | 100% | 100% | 99.9% | 100% | 100% | 99.6% | 97.5% | 100% |
An additional method comparison study for pH was performed using a pH meter as the comparator to support the accuracy of samples with pH $\geq 8.0$ . Confirmatory pH Meter results from 514 specimens that recovered pH $\geq 8.0$ on the CLINITEK Atlas analyzer were used in the calculations. The correlation between the Novus and pH meter showed a $79.4\%$ exact agreement and a $98.1\%$ within one level agreement for pH measurement.
Specific Gravity Method Comparison:
The specific gravity results obtained on the CLINITEK Novus were compared to the specific gravity results obtained on the CLINITEK Atlas. The test range of the samples used for the specific gravity method comparison was: 1.000 to 1.095. The Deming regression analysis is summarized in the table below:
| Analyte | Clinical Site | N | Linear Regression Results |
| --- | --- | --- | --- |
| Specific Gravity | 1 | 628 | y = 1.008x - 0.007, R² = 0.989 |
| | 2 | 624 | y = 1.011x - 0.011, R² = 0.973 |
| | 3 | 741 | y = 1.033x - 0.032, R² = 0.991 |
| | Combined | 1993 | y=1.020x-0.019, R² = 0.983 |
# Color and Clarity Method Comparison
The accuracy of the CLINITEK Novus urine color detection was evaluated by comparing color results from the Novus to the Data Color Mercury 2000, a reference method traceable to the International Color Consortium. Color samples were prepared using non-colored (clear) pooled human urine samples $(\mathrm{SG} = 1.006$ and $\mathrm{pH} = 6.7)$ by adding pigments to produce four samples each of the five CLINITEK Novus block output colors of yellow, dark yellow, orange, red, and green. Each of the colored urine samples was read using three Novus analyzers and the DataColor Mercury 2000. The DataColor Mercury 2000 measurements were converted to HSV color coordinates. The DataColor hue data was compared to the color well to assign color labels to each sample that aligns with the block outputs of the CLINITEK Novus. The results are summarized in the correlation chart below:
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Color Results for CLINITEK Novus vs Reference Method
| CLINITEK Novus Result | Reference Method | | | | |
| --- | --- | --- | --- | --- | --- |
| | Red | Orange | Yellow | Dark Yellow | Green |
| Red | 12 | | | | |
| Orange | | 12 | | | |
| Yellow | | | 11 | | |
| Dark Yellow | | | 1 | 12 | |
| Green | | | | | 12 |
| Grand Total | 12 | 12 | 12 | 12 | 12 |
| Exact Agreement | 100% | 100% | 91.6% | 100% | 100% |
The CLINITEK Novus accuracy in determining urine clarity was evaluated by comparing the clarity results obtained by the device to visually read urine samples. A total of 48 urine samples were obtained with equal distribution across the three categories: clear, cloudy, and turbid. Clarity was read visually by one operator. Samples were then tested for clarity on each of three Novus analyzers. Results from the visual read and analyzer were compared and the results are summarized in the table below:
Clarity Results for CLINITEK Novus vs Visual
| CLINITEK Novus Result | Visual | | |
| --- | --- | --- | --- |
| | Clear | Cloudy | Turbid |
| Clear | 47 | 3 | |
| Cloudy | 1 | 37 | |
| Turbid | | 8 | 48 |
| Grand Total | 48 | 48 | 48 |
| Exact Agreement | 98% | 77% | 100% |
b. Matrix comparison:
Not applicable. The device is for urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
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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:
The sponsor based the CLINITEK Novus reference intervals on literature references. Complete details of the expected analyte values are provided in the labeling.
| Analyte | Expected Values |
| --- | --- |
| Blood | Negative |
| Glucose | Negative |
| Protein | Negative to trace |
| Bilirubin | Negative |
| Ketones | Negative |
| Leukocyte | Negative |
| Nitrite | Negative |
| Urobilinogen | Up to 1.0 mg/dL |
| pH | 5.0-8.0 |
| Specific gravity | 1.016-1.022 (normal fluid intake) |
| Color | Pale yellow to dark yellow |
N. Instrument Name:
CLINITEK Novus Automated Urine Chemistry Analyzer
O. System Descriptions:
1. Modes of Operation:
Single and continuous testing.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X ☐ or No ☐
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3. Specimen Identification:
An internal barcode reader scans the barcode labels on the sample tubes in the racks or sample identification may be entered manually using the touch screen keyboard.
4. Specimen Sampling and Handling:
The CLINITEK Novus system can analyze multiple samples. The sample pipette aspirates a sample from the sample tube and dispenses sample onto each test pad.
5. Calibration:
The system uses four liquid calibration solutions to perform a calibration reflectance check. The calibrators have a fixed value with no lot specific values. A calibration must be performed when a new lot of reagent cassette is loaded onto the system or a new cassette of the same lot is loaded and the calibration is older than 24 hours.
6. Quality Control:
Recommendations for testing quality control are in the labeling. The sponsor recommends that laboratories routinely test at least two levels (negative/low and positive) of an appropriate commercially available control to confirm performance of the urinalysis cassette. Controls may also be randomly placed in each batch of samples tested. Each laboratory should establish its own goals for acceptable standards of performance, and should question handling and testing procedures if these standards are not met.
P. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
Q. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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