# K170623: ACE Hemoglobin A1c (HbA1c) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, LLC
- Decided: Feb 27, 2018 after 363 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: 1 generation back to K951361 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951361: Dca 2000 System for Hemoglobin A1C, Heraeus Kulzer, Inc. (1995) Summary page 4.

## Indications for use
ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of percent hemoglobin A1c in venous whole blood collected in K2-EDTA tubes using the ACE Alera® and ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K170623
Methodology: https://510kreport.com/methodology