# K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann
- Decided: Aug 14, 2013 after 78 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951586 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930104: Ace Clinical Chemistry System, Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- K981377: Ace T4 Reagent T4 Calibrators, Schiapparelli Biosystems, Inc. (1998) Summary page 1.
- K113253: Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent, Alfa Wassermann Diagnostic Technologies, Inc. (2012) Summary page 1.
- K113382: Ace Alt Reagent, Alfa Wassermann (2012) Summary page 1.
- K113438: Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent, Alfa Wassermann Diagnostic Technologies, Inc. (2012) Summary page 1.
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent, Alfa Wassermann Diagnostic Technologies, Inc. (2012) Summary page 10.

## Indications for use
The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K131515
Methodology: https://510kreport.com/methodology