← Product Code [MRR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRR) · K241800

# Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (K241800)

_Siemens Healthcare Diagnostics, Inc. · MRR · Jul 26, 2024 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRR/K241800

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics, Inc.
- **Product Code:** [MRR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRR.md)
- **Decision Date:** Jul 26, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1475
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for Use

Atellica® CH HDL Cholesterol (HDLC) assay The Atellica® CH HDL Cholesterol (HDLC) assay is for in vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) using the Atellica® CH Analyzer. HDLC measurements are used in the diagnosis and treatment of atherosclerosis. Atellica® CH LDL Cholesterol (LDLC) assay The Atellica® CH LDL Cholesterol (LDLC) assay is for in vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin) using the Atellica® CH Analyzer. LDLC measurements are used in the diagnosis and treatment of atherosclerosis.

## Device Story

Atellica CH HDL and LDL assays are in vitro diagnostic reagents for use on the Atellica CH Analyzer. The HDLC assay uses an accelerator selective detergent method; non-HDL cholesterol is consumed by an enzyme reaction; a second reagent solubilizes HDL for colorimetric measurement. The LDLC assay is a homogeneous assay; detergent 1 solubilizes non-LDL particles for enzymatic consumption; detergent 2 solubilizes LDL particles for colorimetric measurement via peroxidase reaction with DSBmT and 4-aminoantipyrine. Output is a quantitative cholesterol concentration (mg/dL) measured via bichromatic endpoint technique. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing and managing atherosclerosis and lipid disorders. Benefits include direct measurement without off-line pretreatment or centrifugation.

## Clinical Evidence

Bench testing only. Studies performed per CLSI guidelines (EP05-A3, EP07-ED3, EP09C-ED3, EP17-A2). Precision (repeatability/within-lab CVs < 3%), linearity, and interference (HIL) verified. Method comparison against predicate devices showed high correlation (r ≥ 0.996). No clinical prospective/retrospective studies conducted.

## Technological Characteristics

Two-reagent enzymatic colorimetric assays. HDLC uses accelerator selective detergent; LDLC uses two-detergent system. Measurement via bichromatic endpoint (545/694 nm). Standardized to NCEP reference methods. Compatible with serum, lithium heparin, sodium heparin, and EDTA plasma. Software-controlled analysis on Atellica CH Analyzer.

## Regulatory Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: K241800

This 510(k) was reviewed under the OHT7/OHT8 OIR's Triage-Quick Review 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRR/K241800](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRR/K241800)

**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).

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