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 |
Intended 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2014
SIEMENS HEALTHCARE DIAGNOSTICS, INC. SUSAN TIBEDO SR. MANAGER REGULATORY AFFAIRS 2 EDGEWATER DRIVE NORWOOD MA 02062
Re: K140717
Trade/Device Name: CLINITEK Novus Automated Urine Chemistry Analyzer CLINITEK Novus 10 Urinalysis Cassette, CLINITEK Novus Calibration Kit Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: II Product Code: JIO, KQO, JJB, JIL, JIN, LJX, JMT, CEN, JIR, JRE, CDM, JIX Dated: September 29, 2014 Received: October 1, 2014
Dear Ms. Susan Tibedo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) k140717
Device Name CLINITEK Novus® Automated Urine Chemistry Analyzer CLINITEK Novus® 10 Urinalysis Cassette CLINITEK Novus® Calibration Kit
Indications for Use (Describe)
The CLINITEK Novus® Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument. 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 seniquantitative 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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary (k140717)
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 1.0 | Submitter Information | |
|-----|--------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | Owner | Siemens Healthcare Diagnostics, Inc.<br>2 Edgewater Drive<br>Norwood, MA 02062 |
| | Contact | Primary: Susan Tibedo<br>Senior Manager Regulatory Affairs<br>susan.tibedo@siemens.com<br>781-269-3888 TEL |
| | | Secondary: Noor Malki<br>VP, Clinical, Regulatory and Quality - POC<br>781-269-3401 TEL |
| | Date Summary Prepared | November 12, 2014 |
| 2.0 | Device Information | |
| | Proprietary Names | CLINITEK Novus® Automated Urine Chemistry<br>Analyzer<br>CLINITEK Novus® 10 Urinalysis Cassette<br>CLINITEK Novus® Calibration Kit |
| | Common Name | Automated Urine Chemistry Analyzer |
| | Main Classification Name | Automated urinalysis system<br>21 CFR 862.2900, Class I<br>Product Code KQO |
# Subsequent Classifications
| Classification | | | | |
|-----------------------------------|-----------------------|-----------------|-----------------|------------------------------------------------------------------------|
| Device | Regulation<br>Section | Device<br>Class | Product<br>Code | Test |
| Automated<br>urinalysis<br>system | 21 CFR 862.2900 | 1 | KQO | Automated Urine Chemistry<br>Analyzer |
| Bilirubin | 21 CFR 862.1115 | 1 | JJB | Urinary bilirubin and its conjugates<br>(non-quantitative) test system |
| Blood (occult) | 21 CFR 864.6550 | 2 | JIO | Occult blood test |
| Glucose | 21 CFR 862.1340 | 2 | JIL | Urinary glucose (non-quantitative)<br>test system |
| Ketone<br>(acetoacetic<br>acid) | 21 CFR 862.1435 | 1 | JIN | Ketones (non-quantitative) test<br>system |
| Leukocytes | 21 CFR 864.7675 | 1 | LJX | Leukocyte peroxidase test |
Page 1 of 19
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| Classification | | | | |
|---------------------|-----------------------|-----------------|-----------------|-----------------------------------------------------------|
| Device | Regulation<br>Section | Device<br>Class | Product<br>Code | Test |
| Nitrite | 21 CFR 862.1510 | 1 | JMT | Nitrite (non-quantitative) test<br>system |
| pH | 21 CFR 862.1550 | 1 | CEN | Urinary pH (nonquantitative) test<br>system |
| Protein | 21 CFR 862.1645 | 1 | JIR | Urinary protein or albumin (non-quantitative) test system |
| Specific<br>gravity | 21 CFR 862.2800 | 1 | JRE | Refractometer for clinical use |
| Urobilinogen | 21 CFR 862.1785 | 1 | CDM | Urinary urobilinogen (non-quantitative) test system |
| Calibrator | 21 CFR 862.1150 | 2 | JIX | Calibrator, multi-analyte mixture |
#### 3.0 Predicate Device
| | Predicate |
|---------------|------------------------------------|
| Device Name | CLINITEK Atlas |
| Common Name | Automated Urine Chemistry Analyzer |
| 510(k) Number | K932674 |
| Manufacturer | Siemens Healthcare Diagnostics |
#### 4.0 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. The analyzer automates the process of urine strip testing by dispensing urine samples onto a test pad, and then by reading the color and intensity of light reflected from the reacted test pads, converts the results into clinically meaningful units.
Test results from the test pads are qualitative and semi-quantitative; specific gravity is measured by a refractometer assembly.
| Analyte | Abbreviation | Conventional<br>Semi-Quantitative | SI<br>Semi-Quantitative | Qualitative |
|--------------------------------------|-----------------|-----------------------------------------|-------------------------|-------------|
| Bilirubin | BIL | Negative | Negative | Negative |
| | | Small | Small | 1+ |
| | | Moderate | Moderate | 2+ |
| | | Large | Large | 3+ |
| Analyte | Abbreviation | Conventional<br>Semi-Quantitative | SI<br>Semi-Quantitative | Qualitative |
| Blood | BLO | Negative | Negative | Negative |
| | | Trace | Trace | Trace |
| | | NHT | NHT | NHT |
| | | Small | Small | 1+ |
| | | Moderate | Moderate | 2+ |
| | | Large | Large | 3+ |
| Glucose | GLU | Negative | Negative | Negative |
| | | 100 mg/dL | 5.5 mmol/L | Trace |
| | | 250 mg/dL | 14 mmol/L | 1+ |
| | | 500 mg/dL | 28 mmol/L | 2+ |
| | | 1000 mg/dL | >=55 mmol/L | 3+ |
| Ketone | KET | Negative | Negative | Negative |
| | | Trace | Trace | Trace |
| | | 15 mg/dL | 1.5 mmol/L | 1+ |
| | | 40 mg/dL | 3.9 mmol/L | 2+ |
| | | 80 mg/dL | 7.8 mmol/L | 3+ |
| | | >=160 mg/dL | >=15.6 mmol/L | 4+ |
| Leukocyte | LEU | Negative | Ca 15 cells/µL | Negative |
| | | Trace | Ca 15 cells/µL | Trace |
| | | Small | Ca 70 cells/µL | 1+ |
| | | Moderate | Ca 125 cells/µL | 2+ |
| | | Large | Ca 500 cells/µL | 3+ |
| Nitrite | NIT | Negative | Negative | Negative |
| | | Positive | Positive | Positive |
| pH | pH | 5.0 | 5.0 | 5.0 |
| | | 5.5 | 5.5 | 5.5 |
| | | 6.0 | 6.0 | 6.0 |
| | | 6.5 | 6.5 | 6.5 |
| | | 7.0 | 7.0 | 7.0 |
| | | 7.5 | 7.5 | 7.5 |
| | | 8.0 | 8.0 | 8.0 |
| | | 8.5 | 8.5 | 8.5 |
| | | >=9.0 | >=9.0 | >=9.0 |
| Analyte | Abbreviation | Conventional<br>Semi-Quantitative | SI<br>Semi-Quantitative | Qualitative |
| Protein | PRO | Negative | Negative | Negative |
| | | Trace | Trace | Trace |
| | | 30 mg/dL | 0.3 g/L | 1+ |
| | | 100 mg/dL | 1.0 g/L | 2+ |
| | | 300 mg/dL | 3.0 g/L | 3+ |
| | | >=1000 mg/dL | >=10.0 g/L | 4+ |
| Specific<br>Gravity<br>(0.005 units) | SG | <=1.005 | <=1.005 | <=1.005 |
| | | 1.010 | 1.010 | 1.010 |
| | | 1.015 | 1.015 | 1.015 |
| | | 1.020 | 1.020 | 1.020 |
| | | 1.025 | 1.025 | 1.025 |
| | | >=1.030 | >=1.030 | >=1.030 |
| Specific<br>Gravity<br>(0.001 units) | SG | 1.000 to <=1.099 in increments of 0.001 | | |
| Urobilinogen | URO<br>UBG (SI) | 0.2 E.U./dL<br>(mg/dL) | 3.2 µmol/L | 0.2 E.U./dL |
| | | 1 E.U./dL | 16 µmol/L | 1 E.U./dL |
| | | 2 E.U./dL | 33 µmol/L | 2 E.U./dL |
| | | 4 E.U./dL | 66 µmol/L | 4 E.U./dL |
| | | >=8 E.U./dL | >=131µmol/L | >=8 E.U./dL |
| Color | COL | Yellow | Yellow | Yellow |
| | | Dark Yellow | Dark Yellow | Dark Yellow |
| | | Orange | Orange | Orange |
| | | Red | Red | Red |
| | | Green | Green | Green |
| | | Other | Other | Other |
| Clarity | CLA | Clear | Clear | Clear |
| | | Cloudy | Cloudy | Cloudy |
| | | Turbid | Turbid | Turbid |
| | | Sl. Cloudy | Sl. Cloudy | Sl. Cloudy |
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#### 5.0 Intended Use Statement
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.
| 6.0 | Summary Comparison of Technological Characteristics | | | |
|-----|-----------------------------------------------------|--|--|--|
|-----|-----------------------------------------------------|--|--|--|
| Feature | Candidate Device<br>CLINITEK Novus analyzer | Predicate Device<br>CLINITEK Atlas analyzer |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Automated Urine Chemistry Analyzer<br>intended for professional in vitro<br>diagnostic use in clinical laboratories.<br><br>The analyzer is intended for the<br>measurement of the following<br>components in urine: bilirubin, blood<br>(occult), glucose, ketone (acetoacetic<br>acid), leukocytes, nitrite, pH, protein,<br>urobilinogen and specific gravity. | Same |
| Urinalysis<br>Strips<br>Analytical<br>Method | Light is reflected at specific<br>wavelengths from the test pad "read<br>area". Reported results depend upon<br>the degree of color change and<br>intensity in the pad which is directly<br>related to the concentration of the<br>analyte in the urine. | Same |
| Feature | Candidate Device<br>CLINITEK Novus analyzer | Predicate Device<br>CLINITEK Atlas analyzer |
| Specific<br>Gravity | Fiber optic refractive index method. | Same |
| Instrument<br>Optical<br>System | Two pairs of LEDs illuminate the test<br>pads and a camera in the analyzer<br>electronically analyzes the color and<br>intensity of the light reflected from the<br>reacted test pads. | Reflectance photometer<br>consisting of halogen lamp,<br>fiber optics and lens and<br>detector.<br>Light travels onto a lens<br>where it is focused onto the<br>detector, and the intensity is<br>converted into electrical<br>impulses to generate<br>clinically meaningful units. |
| Reagent<br>Format | Cassette contains reagent test pads<br>organized in strips on a test card format. | Roll containing reagent test<br>pads in strip format. |
| Reagent<br>Test Pad<br>Chemistry | Each reagent test pad consists of<br>impregnated paper with chemicals<br>specific to measuring the analyte. | Same |
| Reagent<br>Storage and<br>Stability | Storage temperature: 15-30°C<br>Shelf life: 12 months<br>Open shelf life: 14 days | Same |
| Calibration<br>Method | The system performs a cleaning cycle<br>and dry pad calibration. Four, liquid,<br>ready-to-use calibrators are used to<br>calibrate the SG sensor and certain test<br>pads. | Same without dry pad<br>calibration |
| Quality<br>Check | Conducts a quality check to assess if the<br>test pad has been exposed to high<br>humidity. | None |
| Data Storage | 7,500 Patient results<br>200 Calibration results<br>400 Quality control results | 1000 Patient results<br>200 QC / calibrator results |
| Connectivity | LIS, HIS and remote-diagnosis ready.<br>Optional module enables hospital<br>network (such as HIS/LIS) connectivity.<br>This also allows copying a selected<br>setup across multiple instruments via the<br>network. | Same |
| Barcode | Internal barcode reader<br>Optional handheld barcode reader -<br>automatic entry of control lot and<br>expiration | Same |
| User<br>Interface | Integrated color touch screen | Keypad and 12-line display |
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#### 6.0 Summary Comparison of Technological Characteristics
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# Calibrators
#### Similarities and Differences
| Feature | Candidate Device<br>CLINITEK Novus Calibration Kit | Predicate Device<br>CLINITEK Atlas Calibration<br>Kit (k932674) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | In vitro diagnostic product for the<br>calibration of CLINITEK Automated<br>Urine Chemistry Analyzer | Same |
| Preparation | Ready to use | Same |
| Matrix | Liquid | Same |
| Number of calibrators | Four: Calibrator #1, #2, #3 and #4 | Same |
| Cleaning cycle | Includes a cleaning cycle before<br>calibration | Does not include a cleaning cycle before calibration |
| Stability | Shelf-life: 18 months stored at 2-8°C<br>Open bottle: 18 months stored at 2-8°C | Same |
| Traceability | Calibrators have been tested using<br>materials or calibrated devices which<br>are traceable to the National Institute<br>of Standards and Technology in<br>conformance with standard EN<br>17511:2001. | Same |
| Value Assignment | Calibrators are prepared to achieve<br>targeted analyte values. The<br>calibrators have fixed values and are<br>not lot specific. Calibrators must<br>meet internal specifications before<br>release. | Same |
#### 7.0 Test Principle
The CLINITEK Novus analyzer utilizes an optical system that has a 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 tested pads, which are illuminated by two pairs of LED lights. The optical system converts this data into clinically meaningful results.
Specific gravity (SG) 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.
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#### 8.0 Performance Characteristics
### Analytical Performance
### a. Precision / Reproducibility
Precision was evaluated on 3 CLINITEK Novus analyzers over 10 days of testing. Two runs per day were completed with 2 replicates per run across 1 lot of CLINITEK Novus reagent urinalysis cassettes. Commercially available controls were used providing a high positive control, a low clinically significant positive control and a negative control for evaluating the percent agreement. The results are shown in the following tables:
| 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 | < 1.0 mg/dL | 114/120 (95%) | 120/120 (100%) |
#### Table 1. Reproducibility (Within Device) for Low / Negative Control
#### Table 2. Reproducibility (Within Device) for Low Positive Control
| Analyte | Control Limits | Exact Block<br>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%) |
| рн | 7.0-8.0 | 120/120 (100%) | 120/120 (100%) |
| Protein | 30 mg/dL | 120/120 (100%) | 120/120 (100%) |
| ട്ട | 1.006 — 1.019 | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | 2 mg/dL | 120/120 (100%) | 120/120 (100%) |
#### Table 3. Reproducibility (Within Device) High Positive Control
| Analyte | Control Limits | Exact Block<br>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%) |
Siemens Healthcare Diagnostics CLINITEK Novus® Automated Urine Chemistry Analyzer / Traditional 510(k) Page 8 of 19
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| Analyte | Control Limits | Exact Block<br>Agreement | Agreement within ±1 Block |
|--------------|----------------|--------------------------|---------------------------|
| 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%) |
| Table 3. Reproducibility (Within Device) High Positive Control | | |
|----------------------------------------------------------------|--|--|
### b. Detection Limit
The sensitivity of the CLINITEK Novus urinalysis cassette reagents was evaluated by spiking negative pooled human urine with known quantity of analytes. The analytes were spiked at multiple concentrations around the transition value from negative to positive. Multiple samples were tested at each concentration on the CLINITEK Novus analyzer. Sensitivity was defined as the concentration in which ≥ 55% of the results were positive. The lower limits of analyte detection for each reagent test are shown in the following table:
| Analyte | Limit of Detection<br>(Sensitivity) |
|--------------|-------------------------------------|
| Bilirubin | 0.5 mg/dL |
| Blood | 0.013 mg/dL |
| Glucose | 36 mg/dL |
| Ketone | 3.6 mg/dL |
| Leukocyte | 6.0 cells/µL |
| Nitrite | 0.06 mg/dL |
| Protein | 10.8 mg/dL |
| Urobilinogen | 0.24 mg/dL |
### c. Analytical Specificity
Urine samples were spiked with a high concentration of potentially interfering substances. Substances that resulted in a change in the reported clinical block output were serially diluted to determine the concentration at which the substance interfered. The results are in the following table:
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| Interfering<br>Substance | Initial Conc<br>Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
|-------------------------------|------------------------|-----------------------------------|-------------------------------------|------------------------------------|------------------------------------|------------------------------------|-----------------------------------|------------------------------------|-----------------------------------------------|
| Acetaminophen | 40 mg/dL | None | None | None | None | None | None | None | None |
| Acetylcysteine | 270 mg/dL | False<br>Negative at<br>135 mg/dL | False<br>Negative at<br>67.5 mg/dL | False<br>Negative at<br>67.5 mg/dL | False<br>Positive at<br>67.5 mg/dL | None | None | None | False<br>Negative at<br>67.5 mg/dL |
| Ascorbic Acid | 100 mg/dL | False<br>Negative at<br>25 mg/dL | False<br>Negative at<br>25 mg/dL | False<br>Negative at<br>25 mg/dL | None | None | False<br>Negative at<br>100 mg/dL | None | None |
| Ammonium<br>Chloride | 200 mg/dL | None | None | None | None | None | None | None | None |
| Boric Acid | 1000 mg/dL | None | None | None | False<br>Negative at<br>500 mg/dL | None | None | None | None |
| Calcium<br>Chloride | 100 mg/dL | None | None | None | None | False<br>Negative at<br>100 mg/dL | None | None | None |
| Captopril | 50 mg/dL | None | False<br>Negative at<br>12.5 mg/dL | None | False<br>Positive at<br>12.5 mg/dL | None | None | None | False<br>Negative at<br>25 mg/dL |
| Cefoxitin | 66 mg/dL | None | None | None | None | None | None | None | None |
| Cephalosporin | 80 mg/dL | None | None | None | None | None | None | None | None |
| Chlorhexidine | 150 mg/dL | None | False<br>Negative at<br>112.5 mg/dL | None | None | False<br>Negative at<br>37.5 mg/dL | None | False<br>Positive at<br>37.5 mg/dL | False<br>Negative at<br>75 mg/dL |
| Chloroquine | 40 mg/dL | None | False<br>Negative at<br>40 mg/dL | None | None | False<br>Negative at<br>20 mg/dL | None | False<br>Positive at<br>20 mg/dL | None |
| Interfering<br>Substance | Initial Conc<br>Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
| Citric Acid | 80 mg/dL | False<br>Negative at<br>40 mg/dL | None | None | None | None | None | None | None |
| Curcuma | 300 mg/dL | False<br>Negative at<br>75 mg/dL | False<br>Negative at<br>75 mg/dL | None | False<br>Positive at<br>75 mg/dL | False<br>Positive at<br>75 mg/dL | False<br>Positive at<br>75 mg/dL | None | False<br>Negative<br>/Positive at<br>75 mg/dL |
| Formalin | 370 mg/dL | None | False<br>Negative at<br>185 mg/dL | None | False<br>Negative at<br>92.5 mg/dL | False<br>Positive at<br>92.5 mg/dL | False<br>Negative at<br>185 mg/dL | None | False<br>Negative at<br>92.5 mg/dL |
| Galactose | 20 mg/dL | None | None | None | None | None | None | None | None |
| Gentamicin<br>Sulfate | 6 mg/dL | None | None | None | None | None | None | None | None |
| Glucose | 5 g/dL | None | None | NA | None | False<br>Negative at<br>1250 mg/dL | None | None | False<br>Negative at<br>2500 mg/dL |
| Glycine | 400 mg/dL | None | None | None | None | None | None | None | None |
| Glyburide | 15 ug/mL | None | None | None | None | None | None | None | None |
| Hemoglobin | 5 mg/dL | None | None | None | None | None | None | None | None |
| Hypochlorite | 2.60% | False<br>Negative at<br>1.3% | False<br>Positive at<br>0.65% | False<br>Positive at<br>1.3% | False<br>Positive at<br>1.3% | False<br>Negative at<br>0.65% | None | None | False<br>Negative at<br>0.65% |
| Hydrochloro-<br>thiazide | 6 mg/mL | None | None | None | None | None | None | None | False<br>Negative at<br>6 mg/dL |
| Indican | 50 mg/dL | None | None | None | None | None | None | None | None |
| Imipenem | 100 mg/dL | None | None | None | False<br>Positive at<br>50 mg/dL | None | None | None | None |
| Interfering<br>Substance | Initial Conc<br>Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
| Keflex | 150 mg/dL | None | None | None | None | None | None | None | None |
| Keflin | 50 mg/dL | None | None | None | None | None | None | None | None |
| Lactose | 20 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>20 mg/dL |
| Levadopa | 75 mg/dL | None | False<br>Negative at<br>18.8 mg/dL | None | False<br>Positive at<br>56 mg/dL | None | None | None | None |
| Lodine | 100 mg/dL | None | None | None | None | None | None | None | None |
| Meropenem | 100 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>100 mg/dL |
| Mesna | 80 mg/dL | False<br>Negative at<br>20 mg/dL | False<br>Negative at<br>20 mg/dL | False<br>Negative at<br>20 mg/dL | False<br>Positive at<br>20 mg/dL | None | None | None | False<br>Negative at<br>20 mg/dL |
| Metformin | 4 mg/mL | None | None | None | None | None | None | None | None |
| Nitrofurantoin | 120 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>120 mg/dL |
| Oxalic Acid | 95 mg/dL | None | None | None | None | None | False<br>Negative at<br>71 mg/dL | None | None |
| P-<br>aminosalicyclic<br>acid | 250 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>62.5 mg/dL |
| Penicillin | 300 mg/dL | None | None | None | None | None | None | None | None |
| Pyridium | 200 mg/dL | None | None | None | None | None | False<br>Positive at<br>50 mg/dL | False<br>Positive at<br>150 mg/dL | False<br>Positive at<br>100 mg/dL |
| Interfering<br>Substance | Initial Conc<br>Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
| Potassium<br>Chloride | 1200 mg/dL | None | None | None | None | None | None | None | None |
| Quinidine | 30 mg/dL | None | None | None | None | None | None | None | None |
| Riboflavin | 120 mg/dL | None | None | None | None | None | False<br>Positive at<br>30 mg/dL | None | None |
| Sodium Nitrite | 3 mg/dL | None | None | None | None | None | NA | None | None |
| Sulfamethoxaz<br>ole | 70 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>17.5 mg/dL |
| Tagamet | 10 mg/dL | None | None | None | None | None | None | None | False<br>Negative at<br>5 mg/dL |
| Tetracycline | 12 mg/dL | None | None | None | None | None | None | None | None |
| pH > 9 | NA | None | None | None | None | None | None | None | None |
| Microbial<br>Peroxidase | NA | None | False<br>Positive | None | None | None | None | None | None |
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
# Comparison Studies
d. Method Comparison with Predicate Device
The method comparison study compared the clinical results of the CLINITEK Novus analyzer to the predicate device. The study was conducted across 3 sites with up to 2773 specimens tested. The results for overall percent agreement and within one level agreement met acceptance criteria. In the following tables, results are shown for all sites combined.
| BIL | Predicate Result | | | | |
|-----------------------------|------------------|--------|----------|-------|-------|
| | Negative | Small | Moderate | Large | |
| CLINITEK<br>Novus<br>Result | Negative | 2234 | 104 | 1 | 1 |
| | Small | 5 | 190 | 15 | 1 |
| | Moderate | | 1 | 112 | 7 |
| | Large | | | | 102 |
| Total | | 2239 | 295 | 128 | 111 |
| % exact match | | 99.8% | 64.4% | 87.5% | 91.9% |
| % within 1 block | | 100.0% | 100.0% | 99.2% | 98.2% |
| BLO | | Predicate Result | | | | |
|-----------------------------|-----------|------------------|--------|-------|----------|--------|
| | | Negative | Trace | Small | Moderate | Large |
| CLINITEK<br>Novus<br>Result | Negative | 1489 | 4 | 1 | | |
| | Trace/NHT | 34 | 97 | 12 | | |
| | Small | | 18 | 127 | 10 | |
| | Moderate | | | 5 | 125 | 14 |
| | Large | | | | 1 | 204 |
| Total | | 1523 | 119 | 145 | 136 | 218 |
| % exact match | | 97.8% | 81.5% | 87.6% | 91.9% | 93.6% |
| % within 1 block | | 100.0% | 100.0% | 99.7% | 100.0% | 100.0% |
{17}------------------------------------------------
| GLU | | Predicate Result | | | | |
|-----------------------------|---------------|------------------|--------------|--------------|--------------|---------------|
| | | Negative | 100<br>mg/dL | 250<br>mg/dL | 500<br>mg/dL | 1000<br>mg/dL |
| Negative | | 1563 | | | | |
| | 100<br>mg/dL | 7 | 147 | | | |
| CLINITEK<br>Novus<br>Result | 250<br>mg/dL | | 19 | 95 | | |
| | 500<br>mg/dL | | | 8 | 88 | 4 |
| | 1000<br>mg/dL | | | | 4 | 183 |
| Total | | 1570 | 166 | 103 | 92 | 187 |
| % exact match | | 99.6% | 88.5% | 92.2% | 95.7% | 97.9% |
| % within 1 block | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| KET | | Predicate Result | | | | | |
|-----------------------------|-----------|------------------|--------|----------|----------|----------|-----------|
| | | Negative | Trace | 15 mg/dL | 40 mg/dL | 80 mg/dL | 160 mg/dL |
| | Negative | 1670 | 14 | | 1* | | |
| CLINITEK<br>Novus<br>Result | Trace | 2 | 158 | 9 | | | |
| | 15 mg/dL | | 2 | 82 | 6 | | |
| | 40 mg/dL | | | 2 | 117 | 1 | |
| | 80 mg/dL | | | | | 66 | |
| | 160 mg/dL | | | | | 5 | 28 |
| Total | | 1672 | 174 | 93 | 124 | 72 | 28 |
| % exact match | | 99.9% | 90.8% | 88.2% | 94.4% | 91.7% | 100.0% |
| % within 1 block | | 100.0% | 100.0% | 100.0% | 99.2% | 100.0% | 100.0% |
* This is a highly colored sample. Predicate labeling cautions testing of highly colored samples as they may yield a falsely elevated result.
{18}------------------------------------------------
| LEU | | CLINITEK Atlas Result | | | | |
|-----------------------------|----------|-----------------------|--------|-------|----------|--------|
| | | Negative | Trace | Small | Moderate | Large |
| CLINITEK<br>Novus<br>Result | Negative | 1600 | 5 | 1 | | |
| | Trace | 79 | 80 | 13 | | |
| | Small | 1 | 10 | 129 | 3 | |
| | Moderate | | | 16 | 85 | 5 |
| | Large | | | | 6 | 157 |
| Total | | 1680 | 95 | 159 | 94 | 162 |
| % exact match | | 95.0% | 85.7% | 81.1% | 90.4% | 96.6% |
| % within 1 block | | 99.9% | 100.0% | 99.7% | 100.0% | 100.0% |
| NIT | Predicate Result | |
|-----------------------------|------------------|----------|
| | Negative | Positive |
| CLINITEK<br>Novus<br>Result | 1707 | |
| | 12 | 399 |
| Total | 1719 | 399 |
| % exact match | 99.3% | 100.0% |
| % within 1 block | 100.0% | 100.0% |
| pH* | Predicate Result | | | | | | | | |
|-----------------------------|------------------|--------|--------|-------|--------|--------|-------|-------|--------|
| | 5 | 5.5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 | |
| CLINITEK<br>Novus<br>Result | 5 | 85 | 121 | | | | | | |
| | 5.5 | 1 | 203 | 213 | | | | | |
| | 6 | | 1 | 426 | 19 | | | | |
| | 6.5 | | | 26 | 399 | 10 | | | |
| | 7 | | | | 33 | 376 | 2 | | |
| | 7.5 | | | | | 106 | 178 | | |
| | 8 | | | 1 | | | 64 | 44 | 1 |
| | 8.5 | | | | | | 1 | 51 | 49 |
| | >=9.0 | | | | | | | 2 | 361 |
| Total | | 86 | 325 | 666 | 451 | 492 | 245 | 97 | 411 |
| % exact match | | 98.8% | 62.5% | 64.0% | 88.5% | 76.4% | 72.7% | 45.4% | 99.8% |
| % within 1 block | | 100.0% | 100.0% | 99.9% | 100.0% | 100.0% | 99.6% | 97.5% | 100.0% |
*Results on CLINITEK Novus of ≥8.5 were considered a match to a pH of 8.5 on the predicate.
{19}------------------------------------------------
| PRO | | Predicate Result | | | | | |
|-----------------------------|---------------|------------------|--------|-------------|--------------|--------------|---------------|
| | | Negative | Trace | 30<br>mg/dL | 100<br>mg/dL | 300<br>mg/dL | 1000<br>mg/dL |
| Negative | | 1511 | 2 | | | | |
| CLINITEK<br>Novus<br>Result | Trace | 24 | 207 | 4 | | | |
| | 30<br>mg/dL | | 20 | 184 | 3 | | |
| | 100<br>mg/dL | 1 | | 7 | 145 | 1 | |
| | 300<br>mg/dL | | | | 7 | 77 | 8 |
| | 1000<br>mg/dL | | | | | | 71 |
| Total | | 1536 | 229 | 195 | 155 | 78 | 79 |
| % exact match | | 98.4% | 90.4% | 94.4% | 93.5% | 98.7% | 89.9% |
| % within 1 block | | 99.9% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| URO | | Predicate Result | | | | |
|-----------------------------|--------------|------------------|---------|---------|---------|--------|
| | | 0.2 mg/dL | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8mg/dL |
| CLINITEK<br>Novus<br>Result | 0.2<br>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 |
| % exact match | | 99.9% | 85.6% | 91.3% | 89.2% | 93.8% |
| % within 1 block | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
{20}------------------------------------------------
As the number of contrived samples for URO exceeded 15%, testing was also performed at a fourth site. For this fourth site, less than 5% of the samples were contrived. Results are in the following table:
| URO | | Predicate Result | | | | |
|-----------------------------|-----------|------------------|---------|---------|---------|---------|
| | | 0.2<br>mg/dL | 1 mg/dL | 2 mg/dL | 4 mg/dL | 8 mg/dL |
| CLINITEK<br>Novus<br>Result | 0.2 mg/dL | 187 | 2 | | | |
| | 1 mg/dL | | 46 | | | |
| | 2 mg/dL | | | 10 | | |
| | 4 mg/dL | | | | 12 | |
| | 8 mg/dL | | | | | 4 |
| Total | | 187 | 48 | 10 | 12 | 4 |
| % exact match | | 100.0% | 95.8% | 100.0% | 100.0% | 100.0% |
| % within 1 level | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
#### Overall Specific Gravity Slope and Intercept
| Site | N | R2 | Slope | Intercept |
|---------|------|-------|-------|-----------|
| Overall | 1993 | 0.983 | 1.020 | -0.019 |
- c. Matrix Comparison
Not applicable. The device is for urine samples only.
# Clinical Studies
a. Clinical Sensitivity Not applicable
b. Clinical Specificity Not applicable
# Clinical Cut-off
Not applicable
# Expected Values / Reference Range
Complete details of the expected analyte values are provided in the labeling.
#### 9.0 Instrument Name:
CLINITEK Novus Automated Urine Chemistry Analyzer
{21}------------------------------------------------
#### 10.0 System Descriptions
### Modes of Operation
Single and continuous testing.
# 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.
# Specimen Sampling and Handling
The CLINITEK Novus system can analyze multiple sample pipette aspirates a sample from the sample tube and dispenses sample onto each test pad.
# Calibration
The CLINITEK Novus 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.
The calibrators are identical to those cleared in K932674.
# Quality Control
Recommendations for testing quality control are in the labeling. Routinely test at least 2 levels (negative/low and positive) of an appropriate commercially available control to confirm performance of the CLINITEK Novus urinalysis cassette. Controls may also be randomly placed in each batch of samples tested. Each laboratory should establish its own qoals for acceptable standards of performance, and should question handling and testing procedures if these standards are not met.
The CLINITEK Atlas controls, cleared in K932674, may be used with the CLINITEK Novus automated urine chemistry analyzer.
# Other Supportive Instrument Performance Characteristics Data Not Covered in the "Performance Characteristics" Section above:
None
#### 11.0 Conclusion
The results of these studies demonstrate that the CLINITEK Novus automated urine chemistry analyzer and CLINITEK Novus 10 urinalysis cassette is similar to the predicate in both Technological Characteristics and Intended Use. The data presented is a summary of external clinical evaluation, internal laboratory evaluation, and software development information. The CLINITEK Novus performance was shown to be substantially equivalent to the predicate urinalysis device.
