ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

K122757 · Alfa Wassermann Diagnostic Technologies, Inc. · CHH · Oct 5, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122757
• Device Name: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Oct 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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. The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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. The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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. The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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.

Device Story

ACE Axcel Clinical Chemistry System reagents (Cholesterol, HDL-C, LDL-C, Triglycerides) perform quantitative in vitro diagnostic analysis of lipid profiles. System accepts serum or lithium heparin plasma samples; utilizes enzymatic colorimetric assays. Cholesterol/Triglycerides reagents use single-bottle enzymatic reactions; HDL-C/LDL-C reagents use two-bottle detergent-based selective solubilization. Reactions produce colored quinoneimine complexes measured via bichromatic spectrophotometry (absorbance increase proportional to analyte concentration). Operated by laboratory personnel in clinical or physician office settings. Output provides quantitative lipid concentrations to assist clinicians in diagnosing/treating metabolic, cardiovascular, and endocrine disorders.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per EP10-A3 (20 replicates per level). Matrix comparison studies per EP9-A2-IR compared serum vs. lithium heparin plasma across dynamic ranges; results showed high correlation (r > 0.99) and slopes near 1.0, confirming equivalence.

Technological Characteristics

Enzymatic colorimetric assays. Reagents contain enzymes (cholesterol oxidase, cholesterol esterase, peroxidase, lipase, glycerol kinase, glycerol phosphate oxidase), chromogens (4-aminoantipyrine, p-hydroxybenzoic acid, p-chlorophenol, DSBmT), and detergents. Bichromatic spectrophotometric detection. System is a clinical chemistry analyzer. No specific material standards or connectivity details provided.

Indications for Use

Indicated for quantitative determination of cholesterol, HDL-C, LDL-C, and triglycerides in serum and lithium heparin plasma. Used for diagnosis/treatment of lipid metabolism disorders, diabetes mellitus, atherosclerosis, nephrosis, liver/renal diseases, and endocrine disorders. Intended for clinical or physician office laboratory use.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k122757

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.