# K032437: Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 8, 2003 after 62 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960546 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960546: Clinitek 50 Urine Chemistry Analyzer, Bayer Corp. (1996) Summary page 1.

## Indications for use
Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion I1 Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. ChemstripB 5 OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication of leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.

Source page: https://510kreport.com/device/K032437
Methodology: https://510kreport.com/methodology