# K112015: Premier HB9210 HBA1C Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Primus Corporation Dba Trinity Biotech
- Decided: Nov 22, 2011 after 132 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 Premier Hb921 0 System is intended for the quantitative measurement of hemoglobin Aic (HbAlc) in human capillary and venous whole blood. HbAlc is used for the monitoring of tong-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K112015
Methodology: https://510kreport.com/methodology