BAYER CLINITEK STATUS ANALYZER

K031947 · Bayer Healthcare, LLC · KQO · Dec 19, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031947
• Device Name: BAYER CLINITEK STATUS ANALYZER
• Applicant: Bayer Healthcare, LLC
• Product Code: KQO · Clinical Chemistry
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix brand reagent strips), for testing in the clinical laboratory. The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

Device Story

Portable urine chemistry analyzer; reads Bayer Multistix reagent test strips; performs semi-quantitative assays for 12 analytes. Input: reagent test strip; processing: automated optical reading of strip color changes; output: semi-quantitative results displayed on screen in one minute; hardcopy printout available. Used in clinical laboratory settings; operated by laboratory personnel. Features internal printer, serial interface, and battery/AC power. Performs automated self-test and calibration using internal white plastic calibration bar before each test. Provides rapid, standardized urinalysis results to assist clinicians in patient diagnosis and monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Portable urine chemistry analyzer; optical sensing principle for reagent strip analysis; includes internal printer, touch screen interface, and serial computer interface. Operates on AC or battery power. Features automated self-test and calibration using an internal white plastic calibration bar. Designed for use with Bayer Multistix brand reagent strips.

Indications for Use

Indicated for use in clinical laboratories for the semi-quantitative measurement of 12 urine analytes (glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin, and creatinine) using Bayer Multistix brand reagent strips.

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 50 (K960546)
• Multistix Pro (K992257)
• Multistix 10 SG (K905396)
• Clinitek Microalbumin (K972706)

Submission Summary (Full Text)

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K031947

DEC I 9 2003

# Appendix A Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitters Information

2.

| Contact person: | Mary E. Gray, RAC<br>NPT Regulatory Affairs Manager | |
|------------------------|-----------------------------------------------------------------------------------------------------|--|
| Address: | Bayer Healthcare, LLC<br>A subsidiary of Bayer Corporation<br>63 North Street<br>Medfield, MA 02052 | |
| Phone: | [phone] | |
| e-mail address: | [e-mail] | |
| Date Summary Prepared: | June 20, 2003 | |
| Device Information | | |
| Proprietary Name: | Clinitek Status Urinalysis Instrument | |
| Common Name: | Urine chemistry analyzer | |
| Classification Name: | Automated urinalysis system | |
| Classification Number: | 21 CFR 862.2900, Class I | |
| Classification Panel: | Clinical Chemistry and Clinical Toxicology | |

### 3. Predicate Device Information

| Device Name: | Clinitek 50 | Multistix Pro | Multistix 10 SG | Clinitek<br>Microalbumin |
|-------------------|--------------------------|----------------------|----------------------|--------------------------|
| Manufacturer: | Bayer<br>Healthcare, LLC | Bayer<br>Corporation | Bayer<br>Corporation | Bayer<br>Corporation |
| 510(k)<br>Number: | # K960546 | # K992257 | # K905396 | # K972706 |

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## Appendix A Summary of Safety and Effectiveness

#### 4. Device Description

The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Baver urine reagent test strips (Multistix® brand). for testing in the clinical laboratory.

The Clinitek Status reports semi-quantitatively assays for 12 urine analytes [albumin (protein-low), bilirubin, blood (occult), creatinine, glucose, ketone, leukocyte, nitrite, pH, protein (protein-high), specific gravity, and urobilinogen). Reagent strip results are automatically displayed on the Clinitek Status in one (1) minute. A printed hardcopy can also be created either from the results screen or recalled from memory.

The analyzer features a display, internal printer, a serial computer interface, and either electrical outlet or battery operation. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument.

The instrument performs a "self-test" and calibration each time the instrument is turned on. Each time a test is run the analyzer re-calibrates using a white plastic calibration bar located at the back of the test strip table.

#### 5. Statement of Intended Use

The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix® brand reagent strips), for testing in the clinical laboratory.

The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

#### 6. Summary of Technological Characteristics

The Clinitek Status instrument is similar in technological characteristics, device performance and intended use therefore is substantially equivalent to the predicate devices, the Clinitek 50 (# K960546), visual Multistix 10SG (# K905396), Clinitek Microalbumin (# K972706) and Multistix PRO 10LS (# K992257).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2003

Mary E. Gray, RAC NPT Regulatory Affairs Manager Baver HealthCare LLC Diagnostics Division 63 North Street Medfield, MA 02052

Re: k031947

Trade/Device Name: Bayer Clinitek Status® Urine Chemistry Analyzer Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIL, JIP, KQO Dated: October 8, 2003 Received: October 9, 2003

Dear Ms. Gray:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part º20).

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This letter will allow you to begin marketing your device as described in your Section 510{k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K031947

Bayer Clinitek Status® Urine Chemistry Analyzer Device Name:

Indications for Use:

The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix brand reagent strips), for testing in the clinical laboratory.

The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) RC: 1947

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