# K992921: Primus Liquid Control for GHB/Alc Level I and Level II

- Pathway: 510(k) (Traditional)
- Applicant: Primus Corp.
- Decided: Nov 12, 1999 after 74 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K050961: RNA1C Control for Nycocard HBA1C (2005), 0 descendants of its own

## Indications for use
Evaluate glycated hemoglobin test accuracy In vitro diagnostic use only

Source page: https://510kreport.com/device/K992921
Methodology: https://510kreport.com/methodology