# K992257: New Multiples Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Nov 24, 1999 after 141 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MULTISTIX® 10 SG Reagent Strips: named in the summary without a submission number
- (no number) MICROALBUSTIX™ Reagent Strips: named in the summary without a submission number
- (no number) CLINITEK® Microalbumin Reagent Strips: named in the summary without a submission number

## Most influential descendants
- K031947: Bayer Clinitek Status Analyzer (2003), 16 descendants of its own
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), 3 descendants of its own
- K070929: Acon U120 Urine Analyzer, Model U111-101 (2007), 3 descendants of its own
- K141874: Uriscan Optima (2015), 2 descendants of its own

## 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.

Source page: https://510kreport.com/device/K992257
Methodology: https://510kreport.com/methodology