NEW MULTIPLES REAGENT STRIPS

K992257 · Bayer Corp. · JIR · Nov 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992257
• Device Name: NEW MULTIPLES REAGENT STRIPS
• Applicant: Bayer Corp.
• Product Code: JIR · Clinical Chemistry
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The reagent strips also measure physical characteristics, including acid-base balance and urine concentration. The test results can be used along with other diagnostic information to rule out certain disease states.

Device Story

Firm plastic reagent strips for urinalysis; contains pads for low-level protein (albumin), high-level protein, creatinine, blood, glucose, ketone, nitrite, pH, specific gravity, bilirubin, and urobilinogen. Input: urine specimen (random, overnight, or timed). Operation: manual dip and visual color chart comparison or instrumental reading via CLINITEK family of analyzers. Output: semi-quantitative results for analytes and protein-to-creatinine ratio. Used in point-of-care (clinics, physician offices) and centralized labs by professionals. Results assist clinicians in diagnosing kidney, metabolic, liver, and urinary tract conditions; used alongside other diagnostic data to rule out disease states.

Clinical Evidence

Clinical studies conducted in point-of-care and centralized laboratory settings by typical users. Performance of visual and instrumental (CLINITEK analyzers) readings compared to current MULTISTIX 10 SG Reagent Strips and standard laboratory methods. Results demonstrated that the device provides clinical results comparable to current test methods.

Technological Characteristics

Firm plastic strips with multiple reagent pads. Low-level protein assay uses dye-binding (high affinity dye: Bis(3',3"-diiodo-4',4"-dihydroxy-5',5"-dinitrophenyl)-3,4,5,6-tetrabromosulfonephthalein). Creatinine assay uses peroxidase-like activity of copper creatinine complexes catalyzing diisopropylbenzene dihydroperoxide and 3,3',5,5'-tetramethyl-benzidine. Instrumental reading via CLINITEK series analyzers.

Indications for Use

Indicated for at-risk patient groups to assist in diagnosis of kidney function, carbohydrate metabolism (e.g., diabetes), urinary tract infections, and liver function; measures urine physical characteristics. For professional use in point-of-care (physician offices, clinics) and centralized laboratory settings.

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

• MULTISTIX® 10 SG Reagent Strips
• MICROALBUSTIX™ Reagent Strips
• CLINITEK® Microalbumin Reagent Strips

Submission Summary (Full Text)

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## NOV 2 4 1999

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# 510(k) Safety and Effectiveness Summary

| Prepared: | July, 1999 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P. O. Box 70<br>Elkhart, Indiana 46515-0070 |
| Contact: | Syed Ataullah<br>Manager, Regulatory Compliance<br>219-262-6865 |
| Device: | Trade/Proprietary Name: "NEW MULTIPLES" Reagent Strips<br>Common/Usual Name: Multiple Reagent Strips for Urinalysis<br>Document Control Number: K99 2257 |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code - 75 JIR (Urinary protein or albumin) Class 1<br>75 JFY (Creatinine, enzymatic) Class 2 |
| Predicate Device(s): | MULTISTIX® 10 SG Reagent Strips<br>MICROALBUSTIX™ Reagent Strips<br>CLINITEK® Microalbumin Reagent Strips |

Device Description:

Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips for urinalysis that contain reagent areas for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, blood, glucose, ketone (acetoaceticacid), nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein-to-creatinine ratio is also determined. New Multiples Reagent Strips are manually dipped into a urine specimen and "read" visually using a color chart. "NEW MULTIPLES" Reagent Strips may also be read instrumentally, using the CIINITEK® family of Urine Chemistry Analyzers. The method is designed for use with random, overnight or timed specimens. Semi-quantitative results are available within one minute.

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Intended Use:

Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The reagent strips also measure physical characteristics, including acid-base balance and urine concentration. The test results can be used along with other diagnostic information to rule out certain disease states.

### Technological Characteristics:

Bayer's "NEW MULTIPLES" Reagent Strips include new reagent areas for determination of proteinuria. A new protein reagent allows "low level" detection of albumin at 15 mg/dL in addition to the current protein reagent used for detection of "high level" protein at 30 mg/dL. A new creatinine reagent is used that measures creatinine levels from 10 to 300 mg/dL. The protein-to-creatinine ratio is reported as Normal and Abnormal.

The assay for low level protein (albumin) is based on dye binding using the high affinity dye. Bis(3',3"-diiodo-4',4"-dihydroxy-5',5"-dinitrophenyl)-3,4,5,6tetrabromosulfonephthalein). At a constant pH, the development of a blue color is owing to the presence of albumin; the intensity of the color is proportional to the albumin concentration. The assay for creatinine is based on the peroxidase-like activity of copper creatinine complexes that catalyze the reaction of diisopropylbenzene dihydroperoxide and 3,3 ',5 '-tetramethyl-benzidine.

### Assessment of Performance:

The performance of Bayer's "NEW MULTIPLES" Reagent Strips was studied (visually and instumentally using a family of CLINITEK® Analyzers) in clinical setting by typical users. The results were compared to current MULTISTIX® 10 SG Reagent Strips and commonly used laboratory methods. The studies demonstrated that typical users in centralized and point-of-care laboratories can obtain clinical test results that are comparable to commonly used laboratory methods.

#### Conclusion:

Bayer's "NEW MULTIPLES" Reagent Strips have been developed for urinalysis with the currently used reagent areas and new protein-low, protein-high, and creatinine reagent pads. The "NEW MULTIPLES" Reagent Strips are for use in near-patient (point-of-care) and centralized laboratory locations. Studies show that the product provides clinical results comparable to other test methods in current clinical practice.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

NOV 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Sved Ataullah Manager, Regulatory Compliance Bayer Corporation Business Group Diagnostics 1884 Miles Avenue, P.O. Box 70 Elkhart, Indiana 46515-0070

Re: K992257

> Trade Name: "NEW MULTIPLES" Reagent Strips Regulatory Class: II Product Code: JFY, JIL Regulatory Class: I Product Code: JIR, CEN, JRE, JJB, JIO, JIN, JMT, CDM, KOO Dated: October 18, 1999 Received: October 20, 1999

Dear Mr. Ataullah:

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 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). 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. 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 OS 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.

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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 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/dsma/dsmamain.html".

Sincerely yours.

Steven Sutman

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): 长 992257

Device Name:

"NEW MULTIPLES" Reagent Strips

Indications for Use:

Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips that contain reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein to creatinine ratio is also determined. The strips are read visually by comparison to a color chart on the bottle label. The "NEW MULTIPLES" Reagent Strips can also be read instrumentally on the CLINITEK®50, CLINITEK® 100, CLINITEK® 200+ and CLINITEK® 500 Urine Chemistry Analyzers.

Bayer's "NEW MULTIPLES" Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The strips also measure physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. Bayer's "NEW MULTIPLES" Reagent Strips are for professional use in Point -Of-Care locations such as physicians offices or clinics and centralized laboratory locations such as in hospitals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Jean Coopy |
|---------------------------------------|------------|
| (Division Sign-Off) | |
| Division of Clinical Latora y Devices | |
| 510(k) Number | K992957 |

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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