# K112538: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Mar 29, 2012 after 210 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 K962186 (1996). 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)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 2.
- K971526: Ace HDL-C Reagent, Schiapparelli Biosystems, Inc. (1997) Summary page 2.
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls, Schiapparelli Biosystems, Inc. (1999) Summary page 2.

## Indications for use
ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. 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/K112538
Methodology: https://510kreport.com/methodology