# K012829: Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Corp.
- Decided: Nov 2, 2001 after 71 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis. UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.

Source page: https://510kreport.com/device/K012829
Methodology: https://510kreport.com/methodology