# K926469: Variant (TM) Hemoglobin a 1C Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Mar 29, 1993 after 91 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.
22 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984268: Variant II Hemoglobin A1C Program (1998), 21 descendants of its own
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU (2007), 11 descendants of its own
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), 4 descendants of its own
- K040872: Variant II Hemoglobin A1C (2004), 3 descendants of its own
- K090699: Variant II Turbo HBA1C Kit Kit-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730 (2009), 2 descendants of its own

Source page: https://510kreport.com/device/K926469
Methodology: https://510kreport.com/methodology