# K974491: Accu-Chek A1C Hemoglobin Test

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 13, 1998 after 166 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
Longest line of descent: 2 generations back to K861697 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934070: Tina-Quant Hemoglobin A1C, Boehringer Mannheim Corp. (1994) Summary page 1.
- K971919: Ezchek/Hba Blood Collection Kit, Flexsite Diagnostics, Inc. (1997) Summary page 1.

## Most influential descendants
- K983253: Precision A1C Home HBA1C Sample Collection Kit (1998), 0 descendants of its own

## Indications for use
The Accu-Chek A;.™ Hemoglobin Test is designed for use with BMC Hitachi reagents that measure glycosylated hemoglobin. The test has not been evaluated using any other methodology. The device is intended for at-home or in-office use to collect a whole blood sample. The product will be marketed over-the-counter. Test results should be evaluated together with a personal doctor. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient’s diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. This product is not indicated for the diagnosis of diabetes mellitus.

Source page: https://510kreport.com/device/K974491
Methodology: https://510kreport.com/methodology