# K990992: Integra Reagent Cassette for Hemoglobin Alc

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 30, 1999 after 190 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860894 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961824: Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
For the quantitative determination of Hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K990992
Methodology: https://510kreport.com/methodology