MICROALBUSTIX REAGENT STRIPS

K982219 · Bayer Corp. · JIR · Aug 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982219
• Device Name: MICROALBUSTIX REAGENT STRIPS
• Applicant: Bayer Corp.
• Product Code: JIR · Clinical Chemistry
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

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

Device Story

MICROALBUSTIX Reagent Strips are firm plastic strips with two reagent areas for detecting microalbumin and creatinine in urine. The device is used in point-of-care settings (clinics, physician offices, hospitals) by professional healthcare staff. The user dips the strip into a urine specimen and performs a visual comparison of the strip's color against a provided color chart on the label. The albumin test utilizes a high-affinity sulfonephthalein dye (blue color development proportional to albumin concentration). The creatinine test utilizes the peroxidase-like activity of a copper creatinine complex to catalyze a reaction between diisopropylbenzene dihydroperoxide and 3,3',5'-tetramethylbenzidine. An albumin-to-creatinine ratio is determined using a reference table in the package insert. Results are semi-quantitative and available within one minute. The output assists clinicians in identifying patients at risk for kidney damage, facilitating early clinical decision-making.

Clinical Evidence

Performance evaluated in clinical settings by typical users in decentralized, point-of-care laboratories. Results compared to currently used methods for microalbumin and creatinine in urine. Studies demonstrated that users can obtain clinical test results substantially equivalent to current methods.

Technological Characteristics

Firm plastic dip-and-read reagent strips. Albumin detection: dye binding (sulfonephthalein). Creatinine detection: enzymatic (peroxidase-like activity of copper creatinine complex). Visual readout via color chart comparison. Albumin-to-creatinine ratio determined via lookup table. No electronic components or software.

Indications for Use

Indicated for professional screening of urine specimens for microalbuminuria to aid in detecting patients at risk for kidney damage. Provides semi-quantitative results for albumin, creatinine, and albumin-to-creatinine ratio.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Predicate Devices

• CLINITEK® Microalbumin Reagent Strips
• Micral-Test® strips (Roche/Boehringer Mannheim Corporation)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 1 2 1998

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

f

{

KG8219

Page 1 of 2

| 510(k) SAFETY AND EFFECTIVENESS SUMMARY | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared: | June 23, 1998 |
| 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: MICROALBUSTIX™ Reagent Strips<br>Common/Usual Name: Test for albumin in urine<br>Test for creatinine in urine |
| Document Control Number: | K98 |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology |
| Classification Code | 75 CJG (Urinary Albumin, dye binding)<br>75 JFY (Creatinine, enzymatic) |
| Predicate Devices: | CLINITEK® Microalbumin Reagent Strips<br>Manufactured by Bayer Corporation<br>Micral-Test® strips (Roche/Boehringer Mannheim Corporation) |
| Device Description: | MICROALBUSTIX Reagent Strips are firm plastic strips that contain two<br>reagent areas to test for microalbumin (low concentration of albumin) and<br>creatinine in urine. MICROALBUSTIX Reagent Strips are dipped into a<br>urine specimen and "read" visually by comparing the color of the strip to a<br>color chart on the label. In addition to providing an albumin and a creatinine<br>result, an albumin-to-creatinine ratio can also be determined. Semi-<br>quantitative results are available within one minute. |
| Intended Use: | MICROALBUSTIX Reagent Strips are for screening urine specimens for<br>microalbuminuria as an aid in the detection of patients at risk for developing<br>kidney damage. MICROALBUSTIX Reagent Strips are for professional use<br>in point-of-care testing locations such as physician office laboratories, clinics,<br>and hospitals. |

{1}------------------------------------------------

Technological Characteristics:

MICROALBUSTIX Reagent Strips are dip-and-read reagent strips to detection 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 '-tetramethylbenzidine. The color of the reagent areas are read visually by comparing to a color chart on the label. The albumin-tocreatinine ratio is determined according to a table in the package insert.

## Assessment of Performance:

The performance of MICROALBUSTIX 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:

MICROALBUSTIX Reagent Strips 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 2 1998

Rosanne Savol, R.A.C. Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515-0070

K982219 Re : MICROALBUSTIX™ Reagent Strips Regulatory Class: I & II Product Code: JIR, JFY Dated: June 23, 1998 Received: June 24, 1998

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 The general controls provisions of the Act 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulations.

{3}------------------------------------------------

Page 2

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 premarket notification" (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 Litman

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

{4}------------------------------------------------

## 510(k) Number (if known):

Device Name:

## MICROALBUSTIX™ Reagent Strips

Indications for Use: MICROALBUSTIX 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-tocreatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips provide semi-quantitative results and can be used for screening urine specimens for microalbuminuria as an aid in the detection of persons at risk for developing kidney damage. MICROALBUSTIX Reagent Strips are for professional use.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Page 8

P. Bernhardt (for A. Montgomery)
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number