# K003280: Variant II Total GHB

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 19, 2000 after 61 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program (2006), 1 descendant of its own
- K130860: Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K003280
Methodology: https://510kreport.com/methodology