← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K122757 # 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 · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K122757 ## Device Facts - **Applicant:** Alfa Wassermann Diagnostic Technologies, Inc. - **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md) - **Decision Date:** Oct 5, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1175 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} # 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. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K122757](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K122757) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com