# K121842: Architect HBA1C, Architect HBA1C, and Architect HBA1C

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Dec 12, 2012 after 170 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972265 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072686: Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls, Axis-Shield Diagnostics, Ltd. (2008) Summary page 1.

## Recalls of this device
- Apr 9, 2019 · Class III · Z-1356-2019: Devices were delivered without the required dry ice.

## Indications for use
Reagents: The ARCHITECT HbAlc assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin Alc (HbAlc) in human whole blood on the ARCHITECT i System. Percent HbAlc measurements are used for monitoring long term glycemic control in diabetic patients. Calibrators: The ARCHITECT HbAlc Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemnoglobin Alc (HbAlc) in human whole blood.

Source page: https://510kreport.com/device/K121842
Methodology: https://510kreport.com/methodology