# K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 28, 2014 after 392 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934070 (1994). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130002: Tina-Quant HBA1C Gen. 2 Test System, Roche Diagnostics (2013). Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K052101: C.F.a.S. (Calibrator for Automated Systems) HBA1C, Roche Diagnostics (2005) Summary page 2.
- K103099: Precicontrol HBA1C Norm; Precicontrol HBA1C Path, Roche Diagnostics (2010) Summary page 2.

## Most influential descendants
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (2017), 1 descendant of its own
- K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (2021), 0 descendants of its own
- K173206: SEKURE HbA1c Assay (2018), 0 descendants of its own
- K140654: Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (2015), 0 descendants of its own

## Recalls of this device
- Jun 9, 2022 · Class II · Z-1455-2022: There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- Jun 9, 2022 · Class II · Z-1454-2022: There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- Apr 30, 2014 · Class II · Z-0135-2015: HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from 

## Indications for use
The Hemoglobin A Ic assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin Ale (NGSP) or HbAlc fraction mmol/mol (]FCC) in human whole blood and hemolysate on the ARCHITECT c 8000 System. Hemoglobin A Ic measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The Hemoglobin Ale Calibrators are for use in the calibration of the Hemoglobin Ale assay on the ARCHITECT c 8000 System. The Hemoglobin Ale Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT c 8000 System.

Source page: https://510kreport.com/device/K130255
Methodology: https://510kreport.com/methodology