# K042641: Chemview-10

- Pathway: 510(k) (Traditional)
- Applicant: Cenogenics Corp.
- Decided: Jan 7, 2005 after 102 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Roche Chemstrip® urinalysis reagent test strips: named in the summary without a submission number

## Indications for use
CHEMVIEW-10TM is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder. The product will be marketed to physicians' office laboratories, clinics, hospitals and reference laboratories.

Source page: https://510kreport.com/device/K042641
Methodology: https://510kreport.com/methodology