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.

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.

AI/ML Overview

The provided document describes a 510(k) submission for "NEW MULTIPLES" Reagent Strips for urinalysis. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance thresholds with numerical data, such as sensitivity, specificity, or agreement percentages against a gold standard. Instead, it offers a general statement about performance assessment.

Here's a breakdown of the information that can be extracted or inferred based on your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

MISSING: The document does not explicitly state numerical acceptance criteria (e.g., "The device must achieve >90% sensitivity"). It only generically states that performance was comparable.

Reported Device Performance (General Statements):

Parameter Tested	Reported Device Performance
Overall	"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."
Overall	"Studies show that the product provides clinical results comparable to other test methods in current clinical practice."
Protein (low, high) & Creatinine	New reagent areas for these analytes were incorporated, and their performance is encompassed by the general statements above.

2. Sample Size Used for the Test Set and Data Provenance

MISSING: The document does not specify the sample size (number of urine specimens) used for the performance assessment.

Data Provenance: The study was conducted "in clinical setting by typical users." This suggests prospective data collection, likely within US-based healthcare settings given the FDA submission. The document doesn't explicitly state the country of origin, but it's implied to be within the jurisdiction of the submitting company (Bayer Corporation, Elkhart, Indiana, USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

MISSING: The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions comparison to "commonly used laboratory methods." This implies that the ground truth was established by these reference methods, likely performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

MISSING: The document does not describe any adjudication method (e.g., 2+1, 3+1, none). The comparison was made against "commonly used laboratory methods."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

NO: The document does not describe a multi-reader, multi-case comparative effectiveness study with or without AI assistance. The device is a reagent strip for urinalysis, not an AI-powered diagnostic tool. The "readers" are either humans performing visual interpretation or the CLINITEK® Urine Chemistry Analyzers. The comparison is between the "NEW MULTIPLES" Reagent Strips (read visually or instrumentally) and "current MULTISTIX® 10 SG Reagent Strips and commonly used laboratory methods."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

YES (conceptually, for instrumental reading): The device can be "read instrumentally, using the CLINITEK® family of Urine Chemistry Analyzers." When read instrumentally, this represents an "algorithm only" performance (the analyzer's internal algorithms interpreting the color changes). The performance of this instrumental reading was compared to existing methods.

7. Type of Ground Truth Used

The ground truth was established by "commonly used laboratory methods." This implies various laboratory reference tests relevant to each analyte (e.g., quantitative protein assays, enzymatic creatinine assays, culture for UTI, etc.) rather than expert consensus on visual interpretation, pathology, or outcomes data directly.

8. Sample Size for the Training Set

NOT APPLICABLE / MISSING: The document does not describe a "training set" in the context of machine learning or AI. The product is a chemical reagent strip. The development process would involve extensive R&D and formulation optimization, but not typically a "training set" for an learnable algorithm.

9. How the Ground Truth for the Training Set Was Established

NOT APPLICABLE / MISSING: As there's no mention of a training set in the AI sense, this information is not provided. The development of the reagent strips involved chemical principles and optimizations rather than data-driven algorithm training.

Summary

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NOV 2 4 1999

Page 1 of 2

510(k) Safety and Effectiveness Summary

Prepared:	July, 1999
Submitter:	Bayer Corporation, Business Group Diagnostics
Address:	1884 Miles Avenue, P. O. Box 70Elkhart, Indiana 46515-0070
Contact:	Syed AtaullahManager, Regulatory Compliance219-262-6865
Device:	Trade/Proprietary Name: "NEW MULTIPLES" Reagent StripsCommon/Usual Name: Multiple Reagent Strips for UrinalysisDocument Control Number: K99 2257
Classification:	Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 JIR (Urinary protein or albumin) Class 175 JFY (Creatinine, enzymatic) Class 2
Predicate Device(s):	MULTISTIX® 10 SG Reagent StripsMICROALBUSTIX™ Reagent StripsCLINITEK® Microalbumin Reagent Strips

Device Description:

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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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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

(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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Regulation Number and Section

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.