CLINITEK MICROALBUMIN REAGENT STRIPS

K972706 · Bayer Corp. · CJG · Sep 9, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972706
• Device Name: CLINITEK MICROALBUMIN REAGENT STRIPS
• Applicant: Bayer Corp.
• Product Code: CJG · Clinical Chemistry
• Decision Date: Sep 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

CLINITEK® Microalbumin Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.

Device Story

CLINITEK® Microalbumin Reagent Strips are firm plastic strips with two reagent areas for detecting urinary albumin and creatinine. Used in point-of-care settings (clinics, physician offices, hospitals) by professional staff. Strips are dipped into urine specimens and read instrumentally by CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzers. The system measures albumin (20-40 mg/L) and creatinine, calculating an albumin-to-creatinine ratio. Results are displayed or printed within one minute. The device aids clinicians in identifying patients at risk for kidney damage by providing semi-quantitative screening results.

Clinical Evidence

Clinical performance was evaluated in decentralized, point-of-care laboratory settings by typical users. Results were compared against currently used methods for microalbumin and creatinine testing in urine. Studies demonstrated that the system provides clinical results substantially equivalent to existing methods.

Technological Characteristics

Firm plastic reagent strips. Albumin detection via dye binding (high affinity sulfonephthalein dye). Creatinine detection via peroxidase-like activity of copper creatinine complex (diisopropylbenzene dihydroperoxide and 3,3',5,5'-tetramethylbenzidine). Instrumental reading via CLINITEK® 50 or 100 analyzers. Detects albumin at 20-40 mg/L and albumin-to-creatinine ratio at 30-300 mg/g.

Indications for Use

Indicated for professional use in point-of-care settings to screen urine specimens for microalbuminuria as an aid in detecting patients at risk for kidney damage.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• Micral-Test® strips (Boehringer Mannheim Corporation)
• Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.)
• SPQII™ Reagent (INCSTAR Corp.)/Roche COBAS-FARA® II Analyzer/Ciba-Corning Express Plus
• Microprotein Reagent (Sigma Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical System/DuPont XL System
• Quantimetrics BGR Total Protein (Quantimetrics)/TECHNICON RA® 1000 Random Access Analyzer
• CX3 Creatinine Reagent (Beckman)/ Beckman CX3 SYNCHRON® Analyzer
• Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax Analytical System
• Miles Creatinine Reagent (Bayer)/TECHNICON RA 1000 Random Access Analyzer
• Dade® Creatinine Reagent/DuPont XL System
• DCA 2000+ Microalbumin/Creatinine Assay (Bayer)

Submission Summary (Full Text)

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SEP - 9 1991

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# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | July 17, 1997 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70<br>Elkhart, IN 46515<br>[phone] |
| Contact: | Rosanne M. Savol, R.A.C.<br>Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: CLINITEK® Microalbumin Reagent Strips<br>Common/Usual Name: Test for microalbumin in urine<br>Test for creatinine in urine |
| | Document Control Number: K97 |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code - 75 JIR (Urinary Protein or Albumin)<br>75 CGX (Alkaline Picrate, Colorimetry,<br>Creatinine) |
| Predicate Devices: | Micral-Test® strips (Boehringer Mannheim Corporation); Microalbumin<br>Assay/Array® Analyzer (Beckman Instruments Inc.);<br>SPQIITMReagent(INCSTARCorp.)/Roche COBAS-FARA® II<br>Analyzer/Ciba-Corning Express Plus; Microprotein Reagent (Sigma<br>Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical<br>System/DuPont XL System; Quantimetrics BGR Total Protein<br>(Quantimetrics)/TECHNICON RA® 1000 Random Access Analyzer;<br>CX3 Creatinine Reagent (Beckman)/ Beckman CX3 SYNCHRON®<br>Analyzer; Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax<br>Analytical System; Miles Creatinine Reagent (Bayer)/TECHNICON<br>RA 1000 Random Access Analyzer; Dade® Creatinine<br>Reagent/DuPont XL System; DCA 2000+ Microalbumin/Creatinine<br>Assay (Bayer) |

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#### Device Description:

CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.

### Intended Use:

CLINITEK® Microalbumin Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.

#### Technological Characteristics:

The CLINITEK® Microalbumin assay is a dip-and-read reagent strip allowing detection of urinary albumin at 20 to 40 mg/L, and the albumin-to-creatinine ratio of 30 to 300 mg/g. The albumin test is based on dye binding using a high affinity sulfonephthalein dye. At a constant pH, the development of a blue color is due to the presence of albumin. The creatinine test is based on the peroxidase-like activity of a copper creatinine complex that catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3 ,5 ,5 '-tetramethylbenzidine. The color of the reagent areas are read by the CLINITEK® 50 and CLINITEK® 100 instrument at specified times and the results are displayed or printed in clinically meaningful units.

### Assessment of Performance:

The performance of CLINITEK® Microalbumin Reagent Strips was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine in urine. The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods.

#### Conclusion:

CLINITEK® Microalbumin Reagent Strips for use with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers provide a convenient method for screening for microalbumin and creatinine in urine. Studies show that the system can be used in decentralized and point-of-care laboratories and provide clinical results comparable to other test methods in current clinical laboratory practice.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 9 1997

Rosanne M. Savol, R.A.C. . Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46514-0070

Re : K972706 CLINITEK® Microalbumin Reagent Strips Regulatory Class: II Product Code: CJG, JFY Dated: July 17, 1997 Received: July 21, 1997

Dear Ms. Savol:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existinq major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration Choroin" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Indications for Use:

CLINITEK® Microalbumin Reagent Strips

CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria) creatinine) in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| | <div> <img alt="Signature" src="signature.png" width="200"/> </div> <div> Division of Clinical Laboratory Devices </div> <div> 510(k) Number: K972726 </div> | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |
| | | Page® |