# K131351: Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, LLC
- Decided: Aug 15, 2013 after 97 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931786 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113253: Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent, Alfa Wassermann Diagnostic Technologies, Inc. (2012)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- K930104: Ace Clinical Chemistry System, Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- K113436: Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent, Alfa Wassermann (2012) Summary page 10.
- K113382: Ace Alt Reagent, Alfa Wassermann (2012) Summary page 10.

## Recalls of this device
- Mar 5, 2014 · Class II · Z-1529-2014: Extremely low absorbance readings.

## Indications for use
The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. 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/K131351
Methodology: https://510kreport.com/methodology