Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated urine chemistry analyzer that uses optical detection and refractometry. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on traditional analytical and method comparison metrics.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) device used to analyze urine and assist in the diagnosis of various conditions, not to treat them.

Diagnostic

Yes

The device is explicitly stated to "assist diagnosis" for various conditions such as diabetes mellitus, kidney function issues, liver function issues, metabolic disorders, and urinary tract infections. It is also labeled for "in vitro diagnostic use."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "fully automated urine chemistry analyzer" and mentions hardware components like a "refractometer assembly" and an "optical system with a digital imager." This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use." and "This product is for professional in vitro diagnostic use."
Nature of the Device: The device analyzes urine samples to measure various chemical parameters. This process is performed in vitro (outside of the living body) on biological specimens for diagnostic purposes.
Intended Use: The measurements are used to "assist diagnosis" in various medical areas, which is a core function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

JIO, KQO, JJB, JIL, JIN, LJX, JMT, CEN, JIR, JRE, CDM, JIX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratory (for professional in vitro diagnostic use)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Method comparison study comparing the clinical results of the CLINITEK Novus analyzer to the predicate device.
Sample size: Up to 2773
Study Sites: 3 major sites and an additional 4th site for Urobilinogen (URO)
Key results: The results for overall percent agreement and within one level agreement met acceptance criteria.

Key Metrics from the Method Comparison Studies (exact match and within 1 block agreement):

Bilirubin (BIL):
- % exact match: Negative 99.8%, Small 64.4%, Moderate 87.5%, Large 91.9%
- % within 1 block: Negative 100.0%, Small 100.0%, Moderate 99.2%, Large 98.2%
Blood (BLO):
- % exact match: Negative 97.8%, Trace 81.5%, Small 87.6%, Moderate 91.9%, Large 93.6%
- % within 1 block: Negative 100.0%, Trace 100.0%, Small 99.7%, Moderate 100.0%, Large 100.0%
Glucose (GLU):
- % exact match: Negative 99.6%, 100 mg/dL 88.5%, 250 mg/dL 92.2%, 500 mg/dL 95.7%, 1000 mg/dL 97.9%
- % within 1 block: Negative 100.0%, 100 mg/dL 100.0%, 250 mg/dL 100.0%, 500 mg/dL 100.0%, 1000 mg/dL 100.0%
Ketone (KET):
- % exact match: Negative 99.9%, Trace 90.8%, 15 mg/dL 88.2%, 40 mg/dL 94.4%, 80 mg/dL 91.7%, 160 mg/dL 100.0%
- % within 1 block: Negative 100.0%, Trace 100.0%, 15 mg/dL 100.0%, 40 mg/dL 99.2%, 80 mg/dL 100.0%, 160 mg/dL 100.0%
Leukocyte (LEU):
- % exact match: Negative 95.0%, Trace 85.7%, Small 81.1%, Moderate 90.4%, Large 96.6%
- % within 1 block: Negative 99.9%, Trace 100.0%, Small 99.7%, Moderate 100.0%, Large 100.0%
Nitrite (NIT):
- % exact match: Negative 99.3%, Positive 100.0%
- % within 1 block: Negative 100.0%, Positive 100.0%
pH:
- % exact match: 5 (98.8%), 5.5 (62.5%), 6 (64.0%), 6.5 (88.5%), 7 (76.4%), 7.5 (72.7%), 8 (45.4%), 8.5 (99.8%)
- % within 1 block: 5 (100.0%), 5.5 (100.0%), 6 (99.9%), 6.5 (100.0%), 7 (100.0%), 7.5 (99.6%), 8 (97.5%), 8.5 (100.0%)
Protein (PRO):
- % exact match: Negative 98.4%, Trace 90.4%, 30 mg/dL 94.4%, 100 mg/dL 93.5%, 300 mg/dL 98.7%, 1000 mg/dL 89.9%
- % within 1 block: Negative 99.9%, Trace 100.0%, 30 mg/dL 100.0%, 100 mg/dL 100.0%, 300 mg/dL 100.0%, 1000 mg/dL 100.0%
Urobilinogen (URO) - Sites 1-3:
- % exact match: 0.2 mg/dL 99.9%, 1 mg/dL 85.6%, 2 mg/dL 91.3%, 4 mg/dL 89.2%, 8 mg/dL 93.8%
- % within 1 block: 0.2 mg/dL 100.0%, 1 mg/dL 100.0%, 2 mg/dL 100.0%, 4 mg/dL 100.0%, 8 mg/dL 100.0%
Urobilinogen (URO) - Site 4:
- % exact match: 0.2 mg/dL 100.0%, 1 mg/dL 95.8%, 2 mg/dL 100.0%, 4 mg/dL 100.0%, 8 mg/dL 100.0%
- % within 1 level: 0.2 mg/dL 100.0%, 1 mg/dL 100.0%, 2 mg/dL 100.0%, 4 mg/dL 100.0%, 8 mg/dL 100.0%

Overall Specific Gravity Slope and Intercept:

Overall (N=1993): R2 0.983, Slope 1.020, Intercept -0.019

Key Metrics

Precision / Reproducibility:

Bilirubin (BIL):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- Moderate Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- Large Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Blood (BLO):
- Low/Negative Control: Exact Block Agreement 99.2%, Agreement within ±1 Block 100%
- Trace Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- Large Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Glucose (GLU):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- 100 mg/dL Control: Exact Block Agreement 99.2%, Agreement within ±1 Block 100%
- 1000 mg/dL Control: Exact Block Agreement 97.5%, Agreement within ±1 Block 100%
Ketone (KET):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- 15 mg/dL Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- 80 mg/dL Control: Exact Block Agreement 90%, Agreement within ±1 Block 100%
Leukocyte (LEU):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- Small Control: Exact Block Agreement 90.8%, Agreement within ±1 Block 100%
- Large Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Nitrite (NIT):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- Positive Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
pH:
- 9.0 Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Protein (PRO):
- Low/Negative Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- 30 mg/dL Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
- 300 mg/dL Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Specific Gravity (SG):
- /= 1.020 Control: Exact Block Agreement 100%, Agreement within ±1 Block 100%
Urobilinogen (URO):
*

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.

Summary

0

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 Drive
Norwood, MA 02062
	Contact	Primary: Susan Tibedo
Senior Manager Regulatory Affairs
susan.tibedo@siemens.com
781-269-3888 TEL
		Secondary: Noor Malki
VP, Clinical, Regulatory and Quality - POC
781-269-3401 TEL
	Date Summary Prepared	November 12, 2014
2.0	Device Information
	Proprietary Names	CLINITEK Novus® Automated Urine Chemistry
Analyzer
CLINITEK Novus® 10 Urinalysis Cassette
CLINITEK Novus® Calibration Kit
	Common Name	Automated Urine Chemistry Analyzer
	Main Classification Name	Automated urinalysis system
21 CFR 862.2900, Class I
Product Code KQO

Subsequent Classifications

Classification
Device	Regulation
Section	Device
Class	Product
Code	Test
Automated
urinalysis
system	21 CFR 862.2900	1	KQO	Automated Urine Chemistry
Analyzer
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
(acetoacetic
acid)	21 CFR 862.1435	1	JIN	Ketones (non-quantitative) test
system
Leukocytes	21 CFR 864.7675	1	LJX	Leukocyte peroxidase test

Page 1 of 19

4

Classification
Device	Regulation
Section	Device
Class	Product
Code	Test
Nitrite	21 CFR 862.1510	1	JMT	Nitrite (non-quantitative) test
system
pH	21 CFR 862.1550	1	CEN	Urinary pH (nonquantitative) test
system
Protein	21 CFR 862.1645	1	JIR	Urinary protein or albumin (non-quantitative) test system
Specific
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 Semi-Quantitative | SI
Semi-Quantitative | Qualitative |
|--------------------------------------| | Bilirubin | BIL | | | | | | | Analyte Semi-Quantitative | SI
Semi-Quantitative | Qualitative |
| Blood | BLO | | | | | | | | | | | Glucose | GLU | | | | | | | | | Ketone | KET | | | | | | | | | | | Leukocyte | LEU | | | | | | | | | Nitrite | NIT | | | pH | pH | | | | | | | | | | | | | | | | | Analyte Semi-Quantitative | SI
Semi-Quantitative | Qualitative |
| Protein | PRO | | | | | | | | | | | Specific
Gravity
(0.005 units) | SG | =1.030 | Specific
Gravity
(0.001 units) | SG | Color | COL | | | | | | | | | | | Clarity | CLA | | | | | | | Abbreviation | Conventional
-----------------|-----------------------------------------|-------------------------|-------------|
| Negative | Negative | Negative |
| Small | Small | 1+ |
| Moderate | Moderate | 2+ |
| Large | Large | 3+ |
| Abbreviation | Conventional
| Negative | Negative | Negative |
| Trace | Trace | Trace |
| NHT | NHT | NHT |
| Small | Small | 1+ |
| Moderate | Moderate | 2+ |
| Large | Large | 3+ |
| 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+ |
| 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+ |
| 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+ |
| Negative | Negative | Negative |
| Positive | Positive | Positive |
| 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 |
| Abbreviation | Conventional
| 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+ |
| >=1.030 | >=1.030 |
| 1.000 to =8 E.U./dL | >=131µmol/L | >=8 E.U./dL |
| Yellow | Yellow | Yellow |
| Dark Yellow | Dark Yellow | Dark Yellow |
| Orange | Orange | Orange |
| Red | Red | Red |
| Green | Green | Green |
| Other | Other | Other |
| Clear | Clear | Clear |
| Cloudy | Cloudy | Cloudy |
| Turbid | Turbid | Turbid |
| Sl. Cloudy | Sl. Cloudy | Sl. Cloudy |

5

6

7

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
CLINITEK Novus analyzer | Predicate Device
CLINITEK Atlas analyzer |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
(occult), glucose, ketone (acetoacetic
acid), leukocytes, nitrite, pH, protein,
urobilinogen and specific gravity. | Same |
| Urinalysis
Strips
Analytical
Method | Light is reflected at specific
wavelengths from the test pad "read
area". Reported results depend upon
the degree of color change and
intensity in the pad which is directly
related to the concentration of the
analyte in the urine. | Same |
| Feature | Candidate Device
CLINITEK Novus analyzer | Predicate Device
CLINITEK Atlas analyzer |
| Specific
Gravity | Fiber optic refractive index method. | Same |
| 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 test
pads in strip format. |
| Reagent
Test Pad
Chemistry | Each reagent test pad consists of
impregnated paper with chemicals
specific to measuring the analyte. | Same |
| Reagent
Storage and
Stability | Storage temperature: 15-30°C
Shelf life: 12 months
Open shelf life: 14 days | Same |
| Calibration
Method | The system performs a cleaning cycle
and dry pad calibration. Four, liquid,
ready-to-use calibrators are used to
calibrate the SG sensor and certain test
pads. | Same without dry pad
calibration |
| Quality
Check | Conducts a quality check to assess if the
test pad has been exposed to high
humidity. | None |
| Data Storage | 7,500 Patient results
200 Calibration results
400 Quality control results | 1000 Patient results
200 QC / calibrator results |
| Connectivity | LIS, HIS and remote-diagnosis ready.
Optional module enables hospital
network (such as HIS/LIS) connectivity.
This also allows copying a selected
setup across multiple instruments via the
network. | Same |
| Barcode | Internal barcode reader
Optional handheld barcode reader -
automatic entry of control lot and
expiration | Same |
| User
Interface | Integrated color touch screen | Keypad and 12-line display |

8

6.0 Summary Comparison of Technological Characteristics

9

Calibrators

Similarities and Differences

| Feature | Candidate Device
CLINITEK Novus Calibration Kit | Predicate Device
CLINITEK Atlas Calibration
Kit (K932674) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 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 |
| Cleaning cycle | Includes a cleaning cycle before
calibration | Does not include a cleaning cycle before calibration |
| Stability | Shelf-life: 18 months stored at 2-8°C
Open bottle: 18 months stored at 2-8°C | Same |
| Traceability | 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
17511:2001. | Same |
| Value Assignment | Calibrators are prepared to achieve
targeted analyte values. The
calibrators have fixed values and are
not lot specific. Calibrators must
meet internal specifications before
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.

10

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	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:

12

| Interfering
Substance | Initial Conc
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
Negative at
135 mg/dL | False
Negative at
67.5 mg/dL | False
Negative at
67.5 mg/dL | False
Positive at
67.5 mg/dL | None | None | None | False
Negative at
67.5 mg/dL |
| Ascorbic Acid | 100 mg/dL | False
Negative at
25 mg/dL | False
Negative at
25 mg/dL | False
Negative at
25 mg/dL | None | None | False
Negative at
100 mg/dL | None | None |
| Ammonium
Chloride | 200 mg/dL | None | None | None | None | None | None | None | None |
| Boric Acid | 1000 mg/dL | None | None | None | False
Negative at
500 mg/dL | None | None | None | None |
| Calcium
Chloride | 100 mg/dL | None | None | None | None | False
Negative at
100 mg/dL | None | None | None |
| Captopril | 50 mg/dL | None | False
Negative at
12.5 mg/dL | None | False
Positive at
12.5 mg/dL | None | None | None | False
Negative at
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
Negative at
112.5 mg/dL | None | None | False
Negative at
37.5 mg/dL | None | False
Positive at
37.5 mg/dL | False
Negative at
75 mg/dL |
| Chloroquine | 40 mg/dL | None | False
Negative at
40 mg/dL | None | None | False
Negative at
20 mg/dL | None | False
Positive at
20 mg/dL | None |
| Interfering
Substance | Initial Conc
Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
| Citric Acid | 80 mg/dL | False
Negative at
40 mg/dL | None | None | None | None | None | None | None |
| Curcuma | 300 mg/dL | False
Negative at
75 mg/dL | False
Negative at
75 mg/dL | None | False
Positive at
75 mg/dL | False
Positive at
75 mg/dL | False
Positive at
75 mg/dL | None | False
Negative
/Positive at
75 mg/dL |
| Formalin | 370 mg/dL | None | False
Negative at
185 mg/dL | None | False
Negative at
92.5 mg/dL | False
Positive at
92.5 mg/dL | False
Negative at
185 mg/dL | None | False
Negative at
92.5 mg/dL |
| Galactose | 20 mg/dL | None | None | None | None | None | None | None | None |
| Gentamicin
Sulfate | 6 mg/dL | None | None | None | None | None | None | None | None |
| Glucose | 5 g/dL | None | None | NA | None | False
Negative at
1250 mg/dL | None | None | False
Negative at
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
Negative at
1.3% | False
Positive at
0.65% | False
Positive at
1.3% | False
Positive at
1.3% | False
Negative at
0.65% | None | None | False
Negative at
0.65% |
| Hydrochloro-
thiazide | 6 mg/mL | None | None | None | None | None | None | None | False
Negative at
6 mg/dL |
| Indican | 50 mg/dL | None | None | None | None | None | None | None | None |
| Imipenem | 100 mg/dL | None | None | None | False
Positive at
50 mg/dL | None | None | None | None |
| Interfering
Substance | Initial Conc
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
Negative at
20 mg/dL |
| Levadopa | 75 mg/dL | None | False
Negative at
18.8 mg/dL | None | False
Positive at
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
Negative at
100 mg/dL |
| Mesna | 80 mg/dL | False
Negative at
20 mg/dL | False
Negative at
20 mg/dL | False
Negative at
20 mg/dL | False
Positive at
20 mg/dL | None | None | None | False
Negative at
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
Negative at
120 mg/dL |
| Oxalic Acid | 95 mg/dL | None | None | None | None | None | False
Negative at
71 mg/dL | None | None |
| P-
aminosalicyclic
acid | 250 mg/dL | None | None | None | None | None | None | None | False
Negative at
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
Positive at
50 mg/dL | False
Positive at
150 mg/dL | False
Positive at
100 mg/dL |
| Interfering
Substance | Initial Conc
Tested | BIL | BLO | GLU | KET | LEU | NIT | PRO | URO |
| Potassium
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
Positive at
30 mg/dL | None | None |
| Sodium Nitrite | 3 mg/dL | None | None | None | None | None | NA | None | None |
| Sulfamethoxaz
ole | 70 mg/dL | None | None | None | None | None | None | None | False
Negative at
17.5 mg/dL |
| Tagamet | 10 mg/dL | None | None | None | None | None | None | None | False
Negative at
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
Peroxidase | NA | None | False
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
Novus
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
Novus
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
mg/dL	250
mg/dL	500
mg/dL	1000
mg/dL
Negative		1563
	100
mg/dL	7	147
CLINITEK
Novus
Result	250
mg/dL		19	95
	500
mg/dL			8	88	4
	1000
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
Novus
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
Novus
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
Novus
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
Novus
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
mg/dL	100
mg/dL	300
mg/dL	1000
mg/dL
Negative		1511	2
CLINITEK
Novus
Result	Trace	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
% 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
Novus
Result	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
% 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
mg/dL	1 mg/dL	2 mg/dL	4 mg/dL	8 mg/dL
CLINITEK
Novus
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.