# K031042: Atac Hemoglobin A1C Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Nov 3, 2003 after 216 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bayer Hemoglobin A1C reagent: named in the summary without a submission number

## Indications for use
The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C in blood. Hemoglobin A1C results are used to assess the level of control of a patient’s diabetes. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K031042
Methodology: https://510kreport.com/methodology