# K062658: Primus A1CARE Assay

- Pathway: 510(k) (Traditional)
- Applicant: Primus Corp.
- Decided: Nov 26, 2007 after 446 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: 1 generation back to K891235 (1989). 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)
- K891235: Primus Model CLC 330, Primus, Inc. (1989) Summary page 1.

## Indications for use
The Primus Alcare Assay A1c test, for use with the TRIstat Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K062658
Methodology: https://510kreport.com/methodology