# K984268: Variant II Hemoglobin A1C Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 17, 1998 after 17 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
Longest line of descent: 1 generation back to K926469 (1993). 1 ancestor in all.
21 later devices descend from it; 6 cite 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)
- K926469: Variant (TM) Hemoglobin a 1C Program, Bio-Rad (1993) Summary page 1.

## Most influential descendants
- 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
- K063400: Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 (2006), 2 descendants of its own

## Recalls of this device
- Jan 22, 2009 · Not classified · Z-1902-2010: Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
- Jan 22, 2009 · Not classified · Z-1901-2010: Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

## Indications for use
The VARIANT™ II Hemoglobin A, Program is intended for the determination of hemoglobin A in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The VARIANT™ II Hemoglobin A, Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K984268
Methodology: https://510kreport.com/methodology