# K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Aug 6, 2012 after 259 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 K951586 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 2.
- K063306: Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls, Model C2-72, Alfa Wassermann, Inc. (2007) Summary page 2.
- K981375: Ace T Uptake Reagent TU Calibrators, Schiapparelli Biosystems, Inc. (1998) Summary page 2.
- K981377: Ace T4 Reagent T4 Calibrators, Schiapparelli Biosystems, Inc. (1998) Summary page 2.
- K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set, Kamiya Biomedical Co. (2005) Summary page 2.

## Most influential descendants
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (2013), 0 descendants of its own

## Indications for use
ACE Hemoglobin Ale (HbAlIc) Reagent is intended for the quantitative determination of hemoglobin AlIe (pmol/l and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Ale using the ACE Axcel Clinical Chemistry System. The 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 ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sties of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K113437
Methodology: https://510kreport.com/methodology