CLINITEK 50 URINE CHEMISTRY ANALYZER

K960546 · Bayer Corp. · KQO · Jun 12, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960546
• Device Name: CLINITEK 50 URINE CHEMISTRY ANALYZER
• Applicant: Bayer Corp.
• Product Code: KQO · Clinical Chemistry
• Decision Date: Jun 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.

Device Story

Portable reflectance spectrophotometer for physician office laboratories; analyzes reacted Bayer Reagent Strips. User manually dips strip into urine specimen; places strip on analyzer. Instrument times reactions; measures reflectance; converts data to clinically meaningful units corresponding to reagent strip color charts. Outputs displayed on instrument; printed; or transferred to laboratory computer for data management. Automates visual readout process; improves consistency; provides objective urinalysis results for clinical decision-making.

Clinical Evidence

In-house and clinical evaluations conducted to demonstrate performance equivalence to predicate devices and ease of operation for intended users. Results confirm device is equivalent in performance to predicates.

Technological Characteristics

Portable reflectance spectrophotometer. Measures reflectance off reacted reagent strips. Converts reflectance to clinically meaningful units. Connectivity via laboratory computer interface. Designed for physician office laboratories.

Indications for Use

Indicated for routine urinalysis in patients requiring testing for glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, specific gravity, and urine color.

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

• MULTISTIX® 10-SG Reagent Strips for Urinalysis (visual readout)
• CLINITEK® 200+ Urine Chemistry Analyzer
• CLINITEK® ATLAS Urine Chemistry Analyzer

Submission Summary (Full Text)

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Bayer Corporation, Business Group Diagnostics
CLINITEK® 50 Urine Chemistry Analyzer

510(k) Safety and Effectiveness Summary
Page 1 of 2

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: February 5, 1996
K960546

Submitter: Bayer Corporation, Business Group Diagnostics

Address: 1884 Miles Avenue, P. O. Box 70
Elkhart, IN 46515
[phone]

JUN 12 1996

Contact: Rosanne M. Savol, R.A.C.
Manager, Regulatory Affairs

Device: Trade Name: CLINITEK 50 Urine Chemistry Analyzer
Common Name: Urine chemistry analyzer
Document Control Number: K96

Classification Information: Division of Clinical Laboratory Devices
Panel - Clinical Chemistry and Toxicology
Classification Code -- 75 KQO (automated urinalysis system)

Predicate Devices: MULTISTIX® 10-SG Reagent Strips for Urinalysis
(visual readout)
CLINITEK® 200+ Urine Chemistry Analyzer
CLINITEK® ATLAS Urine Chemistry Analyzer

Device Description: The CLINITEK 50 Urine Chemistry Analyzer is a portable reflectance spectrophotometer that instrumentally measures the reflectance off a reacted Bayer Reagent Strip for Urinalysis. The CLINITEK 50 Urine Chemistry Analyzer displays and prints urinalysis results and can be connected to a laboratory computer for data management.

Intended Use: The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.

{1}

Bayer Corporation, Business Group Diagnostics
CLINITEK® 50 Urine Chemistry Analyzer

## Technological Characteristics:

The CLINITEK 50 Urine Chemistry Analyzer is a reflectance spectrophotometer. It has similar technological characteristics to other CLINITEK® Urine Chemistry Analyzers such as the CLINITEK 200+ and CLINITEK ATLAS Analyzers. It is a small, portable instrument which makes it suitable for physician office laboratories. The user manually dips a Bayer Reagent Strip into a urine specimen and places it on the CLINITEK 50 Urine Chemistry Analyzer. The instrument times the reactions on the strip, measures the reflectance off the strip and converts the results to clinically meaningful units that correspond to the color chart on the bottle label of the strip. The urinalysis results are displayed on the instrument and can be printed or transferred to a laboratory computer.

## Performance Studies:

Studies were conducted in-house and in clinical settings to demonstrate that the performance of the CLINITEK 50 Urine Chemistry Analyzer is equivalent to the predicate devices and that the intended user can easily operate the instrument and obtain urinalysis results.

## Conclusion:

The results of in-house and clinical evaluations of the CLINITEK 50 Urine Chemistry Analyzer demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use.