# K063306: Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls, Model C2-72

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann, Inc.
- Decided: Apr 17, 2007 after 167 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Tosoh Bioscience, Inc. A1c 2.2 Plus Automated Glycohemoglobin Assay: named in the summary without a submission number
- (no number) General Atomics, Inc. Hemoglobin A1c Enzymatic Assay: named in the summary without a submission number

## Most influential descendants
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent (2012), 1 descendant of its own
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (2013), 0 descendants of its own

## Indications for use
ACE® Hemoglobin Alc (HbAlc) Reagent is intended for the quantitative determination of hemoglobin Alc (itmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Alc using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only. The pmol HbAlc and total hemoglobin (THb) values generated are intended for use in the calculation of the HbAlc/THb ratio and cannot be used individually for diagnostic purposes. Hemoglobin Alc Calibrators are intended for use in the performance of both a multi-point calibration for hemoglobin Al c and a single-point calibration of total hemoglobin on the ACE® clinical chemistry system, for the quantitative determination of percent (%) hemoglobin Alc in whole blood. For in vitro diagnostic use only. Hemoglobin Al c Controls are intended to reliably monitor the accuracy and precision of quantitative determinations of hemoglobin Al c on the ACE® clinical chemistry system. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K063306
Methodology: https://510kreport.com/methodology