# K952337: Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Feb 9, 1996 after 266 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961824: Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin (1996), 1 descendant of its own
- K030553: Arkit HBA1C (2003), 0 descendants of its own
- K990992: Integra Reagent Cassette for Hemoglobin Alc (1999), 0 descendants of its own

## Recalls of this device
- Feb 15, 2005 · Not classified · Z-0650-05: The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Feb 15, 2005 · Not classified · Z-0651-05: The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

Source page: https://510kreport.com/device/K952337
Methodology: https://510kreport.com/methodology