# K140654: Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 22, 2015 after 434 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- 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: 3 generations back to K934070 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls, Abbott Laboratories (2014) Summary page 5.

## Recalls of this device
- 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.
- May 22, 2019 · Class II · Z-1688-2020: Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.

## Indications for use
The Hemoglobin A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 4000 System. Hemoglobin A1c 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 A1c Calibrators are for use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 4000 System. The Hemoglobin A1c Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the Hemoglobin A1c assay on the ARCHITECT c 4000 System.

Source page: https://510kreport.com/device/K140654
Methodology: https://510kreport.com/methodology