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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% agreement"). However, it does present the results of comparison studies against a predicate device and states that "The results for overall percent agreement and within one level agreement met acceptance criteria." This implies that acceptable thresholds were achieved. Based on the presented data, we can infer the achieved performance. For specific analytes, the values vary, but they consistently show high exact match and very high agreement within +/- 1 block.

Analyte	Performance Metric	CLINITEK Novus Result (All Sites Combined)	Implied/Achieved Acceptance Criteria (based on "met acceptance criteria")
Bilirubin	% exact match (range)	64.4% - 99.8%	High % (exact match)
	% within 1 block (range)	98.2% - 100.0%	Very high % (within 1 block)
Blood	% exact match (range)	81.5% - 97.8%	High % (exact match)
	% within 1 block (range)	100.0% (except one at 99.7%)	Very high % (within 1 block)
Glucose	% exact match (range)	88.5% - 99.6%	High % (exact match)
	% within 1 block (range)	100.0%	Very high % (within 1 block)
Ketone	% exact match (range)	88.2% - 100.0%	High % (exact match)
	% within 1 block (range)	99.2% - 100.0%	Very high % (within 1 block)
Leukocyte	% exact match (range)	81.1% - 96.6%	High % (exact match)
	% within 1 block (range)	99.9% - 100.0%	Very high % (within 1 block)
Nitrite	% exact match (range)	99.3% - 100.0%	High % (exact match)
	% within 1 block (range)	100.0%	Very high % (within 1 block)
pH	% exact match (range)	45.4% - 99.8%	High % (exact match)
	% within 1 block (range)	97.5% - 100.0%	Very high % (within 1 block)
Protein	% exact match (range)	89.9% - 98.7%	High % (exact match)
	% within 1 block (range)	99.9% - 100.0%	Very high % (within 1 block)
Urobilinogen	% exact match (range) (sites 1-3)	85.6% - 99.9%	High % (exact match)
	% within 1 block (range) (sites 1-3)	100.0%	Very high % (within 1 block)
Urobilinogen	% exact match (range) (site 4)	93.8% - 100.0%	High % (exact match)
	% within 1 block (range) (site 4)	100.0%	Very high % (within 1 block)
Specific Gravity	R2	0.983	High R2 (correlation)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- For the method comparison study (comparing CLINITEK Novus to the predicate CLINITEK Atlas), up to 2773 specimens were tested across 3 sites for most analytes.
- For Urobilinogen, an additional fourth site was involved due to a high number of contrived samples in the initial three sites. This fourth site tested 261 samples (187 negative, and then 48, 10, 12, 4 for various positive levels).
Data Provenance: The document does not explicitly state the country of origin. The study was conducted "across 3 sites" (and later a fourth), implying a multi-center study within the scope of the device manufacturer's operations/clinical trials. It is a prospective comparison study as it compared the new device (CLINITEK Novus) against an existing predicate device (CLINITEK Atlas) using actual patient specimens.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The context of this device being an automated urine chemistry analyzer comparing its readings to a predicate automated urine chemistry analyzer suggests that the "ground truth" for the test set was established by the results from the predicate device (CLINITEK Atlas), not human experts. Therefore, the concept of a number of experts and their qualifications for establishing ground truth is not directly applicable in this context. The predicate device's established performance serves as the reference.

4. Adjudication Method for the Test Set

Since the comparison is primarily between two automated devices, and the "ground truth" is derived from the predicate device's readings, a typical adjudication method involving human readers (like 2+1 or 3+1 consensus) is not applicable. The data presented is a direct comparison of the readings obtained from the CLINITEK Novus analyzer against the readings obtained from the CLINITEK Atlas analyzer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance was not performed. This device is an automated in vitro diagnostic (IVD) analyzer, not an AI-powered image analysis tool meant to assist human readers. Its primary function is to automatically measure chemical parameters in urine.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?

Yes, the performance reported is a standalone performance of the CLINITEK Novus Automated Urine Chemistry Analyzer. It assesses the device's ability to accurately measure urine parameters independently, by comparing its results directly to those of a predicate automated device. There is no human-in-the-loop component in the reported performance evaluation.

7. The Type of Ground Truth Used

The primary "ground truth" used for the method comparison study was the results obtained from the predicate device, the CLINITEK Atlas Automated Urine Chemistry Analyzer. For the detection limit study, "ground truth" was established by spiking negative pooled human urine with known quantities of analytes.

8. The Sample Size for the Training Set

The document describes studies comparing the new device to a predicate device and analytical performance characteristics. It does not explicitly mention a "training set" or a machine learning/AI model training process for this IVD device. The description focuses on demonstrating substantial equivalence to a predicate device through analytical and method comparison studies. If the device uses algorithms derived from prior data, that information is not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" is not explicitly mentioned in the context of machine learning/AI for this device, the method for establishing its ground truth is not applicable/not provided in this document. The device's operation appears to be based on established reflectance photometry and refractive index principles for chemical analysis, rather than a learned model from a training set.

Summary

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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)

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.

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.2 Edgewater DriveNorwood, MA 02062
	Contact	Primary: Susan TibedoSenior Manager Regulatory Affairssusan.tibedo@siemens.com781-269-3888 TEL
		Secondary: Noor MalkiVP, Clinical, Regulatory and Quality - POC781-269-3401 TEL
	Date Summary Prepared	November 12, 2014
2.0	Device Information
	Proprietary Names	CLINITEK Novus® Automated Urine ChemistryAnalyzerCLINITEK Novus® 10 Urinalysis CassetteCLINITEK Novus® Calibration Kit
	Common Name	Automated Urine Chemistry Analyzer
	Main Classification Name	Automated urinalysis system21 CFR 862.2900, Class IProduct Code KQO

Subsequent Classifications

Classification
Device	RegulationSection	DeviceClass	ProductCode	Test
Automatedurinalysissystem	21 CFR 862.2900	1	KQO	Automated Urine ChemistryAnalyzer
Bilirubin	21 CFR 862.1115	1	JJB	Urinary bilirubin and its conjugates(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)test system
Ketone(acetoaceticacid)	21 CFR 862.1435	1	JIN	Ketones (non-quantitative) testsystem
Leukocytes	21 CFR 864.7675	1	LJX	Leukocyte peroxidase test

Page 1 of 19

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Classification
Device	RegulationSection	DeviceClass	ProductCode	Test
Nitrite	21 CFR 862.1510	1	JMT	Nitrite (non-quantitative) testsystem
pH	21 CFR 862.1550	1	CEN	Urinary pH (nonquantitative) testsystem
Protein	21 CFR 862.1645	1	JIR	Urinary protein or albumin (non-quantitative) test system
Specificgravity	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

Test results from the test pads are qualitative and semi-quantitative; specific gravity is measured by a refractometer assembly.

Analyte	Abbreviation	ConventionalSemi-Quantitative	SISemi-Quantitative	Qualitative
Bilirubin	BIL	Negative	Negative	Negative
		Small	Small	1+
		Moderate	Moderate	2+
		Large	Large	3+
Analyte	Abbreviation	ConventionalSemi-Quantitative	SISemi-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	ConventionalSemi-Quantitative	SISemi-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+
SpecificGravity(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
SpecificGravity(0.001 units)	SG	1.000 to <=1.099 in increments of 0.001
Urobilinogen	UROUBG (SI)	0.2 E.U./dL(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 DeviceCLINITEK Novus analyzer	Predicate DeviceCLINITEK Atlas analyzer
Intended Use	Automated Urine Chemistry Analyzerintended for professional in vitrodiagnostic use in clinical laboratories.The analyzer is intended for themeasurement of the followingcomponents in urine: bilirubin, blood(occult), glucose, ketone (acetoaceticacid), leukocytes, nitrite, pH, protein,urobilinogen and specific gravity.	Same
UrinalysisStripsAnalyticalMethod	Light is reflected at specificwavelengths from the test pad "readarea". Reported results depend uponthe degree of color change andintensity in the pad which is directlyrelated to the concentration of theanalyte in the urine.	Same
Feature	Candidate DeviceCLINITEK Novus analyzer	Predicate DeviceCLINITEK Atlas analyzer
SpecificGravity	Fiber optic refractive index method.	Same
InstrumentOpticalSystem	Two pairs of LEDs illuminate the testpads and a camera in the analyzerelectronically analyzes the color andintensity of the light reflected from thereacted test pads.	Reflectance photometerconsisting of halogen lamp,fiber optics and lens anddetector.Light travels onto a lenswhere it is focused onto thedetector, and the intensity isconverted into electricalimpulses to generateclinically meaningful units.
ReagentFormat	Cassette contains reagent test padsorganized in strips on a test card format.	Roll containing reagent testpads in strip format.
ReagentTest PadChemistry	Each reagent test pad consists ofimpregnated paper with chemicalsspecific to measuring the analyte.	Same
ReagentStorage andStability	Storage temperature: 15-30°CShelf life: 12 monthsOpen shelf life: 14 days	Same
CalibrationMethod	The system performs a cleaning cycleand dry pad calibration. Four, liquid,ready-to-use calibrators are used tocalibrate the SG sensor and certain testpads.	Same without dry padcalibration
QualityCheck	Conducts a quality check to assess if thetest pad has been exposed to highhumidity.	None
Data Storage	7,500 Patient results200 Calibration results400 Quality control results	1000 Patient results200 QC / calibrator results
Connectivity	LIS, HIS and remote-diagnosis ready.Optional module enables hospitalnetwork (such as HIS/LIS) connectivity.This also allows copying a selectedsetup across multiple instruments via thenetwork.	Same
Barcode	Internal barcode readerOptional handheld barcode reader -automatic entry of control lot andexpiration	Same
UserInterface	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 DeviceCLINITEK Novus Calibration Kit	Predicate DeviceCLINITEK Atlas CalibrationKit (K932674)
Intended Use	In vitro diagnostic product for thecalibration of CLINITEK AutomatedUrine 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 beforecalibration	Does not include a cleaning cycle before calibration
Stability	Shelf-life: 18 months stored at 2-8°COpen bottle: 18 months stored at 2-8°C	Same
Traceability	Calibrators have been tested usingmaterials or calibrated devices whichare traceable to the National Instituteof Standards and Technology inconformance with standard EN17511:2001.	Same
Value Assignment	Calibrators are prepared to achievetargeted analyte values. Thecalibrators have fixed values and arenot lot specific. Calibrators mustmeet internal specifications beforerelease.	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 BlockAgreement	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 BlockAgreement	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 BlockAgreement	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(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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InterferingSubstance	Initial ConcTested	BIL	BLO	GLU	KET	LEU	NIT	PRO	URO
Acetaminophen	40 mg/dL	None	None	None	None	None	None	None	None
Acetylcysteine	270 mg/dL	FalseNegative at135 mg/dL	FalseNegative at67.5 mg/dL	FalseNegative at67.5 mg/dL	FalsePositive at67.5 mg/dL	None	None	None	FalseNegative at67.5 mg/dL
Ascorbic Acid	100 mg/dL	FalseNegative at25 mg/dL	FalseNegative at25 mg/dL	FalseNegative at25 mg/dL	None	None	FalseNegative at100 mg/dL	None	None
AmmoniumChloride	200 mg/dL	None	None	None	None	None	None	None	None
Boric Acid	1000 mg/dL	None	None	None	FalseNegative at500 mg/dL	None	None	None	None
CalciumChloride	100 mg/dL	None	None	None	None	FalseNegative at100 mg/dL	None	None	None
Captopril	50 mg/dL	None	FalseNegative at12.5 mg/dL	None	FalsePositive at12.5 mg/dL	None	None	None	FalseNegative at25 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	FalseNegative at112.5 mg/dL	None	None	FalseNegative at37.5 mg/dL	None	FalsePositive at37.5 mg/dL	FalseNegative at75 mg/dL
Chloroquine	40 mg/dL	None	FalseNegative at40 mg/dL	None	None	FalseNegative at20 mg/dL	None	FalsePositive at20 mg/dL	None
InterferingSubstance	Initial ConcTested	BIL	BLO	GLU	KET	LEU	NIT	PRO	URO
Citric Acid	80 mg/dL	FalseNegative at40 mg/dL	None	None	None	None	None	None	None
Curcuma	300 mg/dL	FalseNegative at75 mg/dL	FalseNegative at75 mg/dL	None	FalsePositive at75 mg/dL	FalsePositive at75 mg/dL	FalsePositive at75 mg/dL	None	FalseNegative/Positive at75 mg/dL
Formalin	370 mg/dL	None	FalseNegative at185 mg/dL	None	FalseNegative at92.5 mg/dL	FalsePositive at92.5 mg/dL	FalseNegative at185 mg/dL	None	FalseNegative at92.5 mg/dL
Galactose	20 mg/dL	None	None	None	None	None	None	None	None
GentamicinSulfate	6 mg/dL	None	None	None	None	None	None	None	None
Glucose	5 g/dL	None	None	NA	None	FalseNegative at1250 mg/dL	None	None	FalseNegative at2500 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%	FalseNegative at1.3%	FalsePositive at0.65%	FalsePositive at1.3%	FalsePositive at1.3%	FalseNegative at0.65%	None	None	FalseNegative at0.65%
Hydrochloro-thiazide	6 mg/mL	None	None	None	None	None	None	None	FalseNegative at6 mg/dL
Indican	50 mg/dL	None	None	None	None	None	None	None	None
Imipenem	100 mg/dL	None	None	None	FalsePositive at50 mg/dL	None	None	None	None
InterferingSubstance	Initial ConcTested	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	FalseNegative at20 mg/dL
Levadopa	75 mg/dL	None	FalseNegative at18.8 mg/dL	None	FalsePositive at56 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	FalseNegative at100 mg/dL
Mesna	80 mg/dL	FalseNegative at20 mg/dL	FalseNegative at20 mg/dL	FalseNegative at20 mg/dL	FalsePositive at20 mg/dL	None	None	None	FalseNegative at20 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	FalseNegative at120 mg/dL
Oxalic Acid	95 mg/dL	None	None	None	None	None	FalseNegative at71 mg/dL	None	None
P-aminosalicyclicacid	250 mg/dL	None	None	None	None	None	None	None	FalseNegative at62.5 mg/dL
Penicillin	300 mg/dL	None	None	None	None	None	None	None	None
Pyridium	200 mg/dL	None	None	None	None	None	FalsePositive at50 mg/dL	FalsePositive at150 mg/dL	FalsePositive at100 mg/dL
InterferingSubstance	Initial ConcTested	BIL	BLO	GLU	KET	LEU	NIT	PRO	URO
PotassiumChloride	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	FalsePositive at30 mg/dL	None	None
Sodium Nitrite	3 mg/dL	None	None	None	None	None	NA	None	None
Sulfamethoxazole	70 mg/dL	None	None	None	None	None	None	None	FalseNegative at17.5 mg/dL
Tagamet	10 mg/dL	None	None	None	None	None	None	None	FalseNegative at5 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
MicrobialPeroxidase	NA	None	FalsePositive	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
CLINITEKNovusResult	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
CLINITEKNovusResult	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	100mg/dL	250mg/dL	500mg/dL	1000mg/dL
Negative		1563
	100mg/dL	7	147
CLINITEKNovusResult	250mg/dL		19	95
	500mg/dL			8	88	4
	1000mg/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*
CLINITEKNovusResult	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
CLINITEKNovusResult	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
CLINITEKNovusResult	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
CLINITEKNovusResult	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	30mg/dL	100mg/dL	300mg/dL	1000mg/dL
Negative		1511	2
CLINITEKNovusResult	Trace	24	207	4
	30mg/dL		20	184	3
	100mg/dL	1		7	145	1
	300mg/dL				7	77	8
	1000mg/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
CLINITEKNovusResult	0.2mg/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
		0.2mg/dL	1 mg/dL	2 mg/dL	4 mg/dL	8 mg/dL
CLINITEKNovusResult	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.

Regulation Number and Section

§ 862.2900 Automated urinalysis system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.