LDLC3 LDL-Cholesterol Gen.3

K143691 · Roche Diagnostics Operations (Rdo) · LBR · Jan 28, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143691
• Device Name: LDLC3 LDL-Cholesterol Gen.3
• Applicant: Roche Diagnostics Operations (Rdo)
• Product Code: LBR · Clinical Chemistry
• Decision Date: Jan 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The LDL-Cholesterol Gen. 3 assay is intended for use as an in vitro test for the quantitative determination of LDL-Cholesterol in human serum and plasma on Roche/Hitachi cobas c systems.

Device Story

LDLC3 LDL-Cholesterol Gen. 3 is a homogeneous enzyme colorimetric assay for quantitative measurement of LDL-cholesterol in human serum and plasma. Used on Roche/Hitachi cobas c clinical chemistry analyzers; operated by laboratory professionals. Principle: surfactants selectively solubilize LDL; cholesterol esterase and oxidase break down LDL-cholesterol; peroxidase reacts with 4-aminoantipyrine and EMSE to produce a red-purple dye. Color intensity, measured photometrically, is directly proportional to cholesterol concentration. Output provides quantitative LDL-cholesterol levels to assist clinicians in diagnosing and managing lipid disorders, atherosclerosis, and liver/renal diseases.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines: LoB (0.406 mg/dL), LoD (0.99 mg/dL), LoQ (2.28 mg/dL). Precision (CLSI EP5-A2) showed CVs 0.7-2.5%. Linearity (CLSI EP6-A) confirmed 3.87-549 mg/dL range. Method comparison (n=100) against predicate yielded Passing/Bablok regression y = 0.984x + 0.786, r = 0.999. Interference testing confirmed no significant impact from common drugs, VLDL, HDL, chylomicrons, or endogenous substances (hemoglobin, lipemia, bilirubin) within specified limits.

Technological Characteristics

Homogeneous enzyme colorimetric assay. Reagents: R1 (Bis-tris buffer, ascorbic oxidase, peroxidase, BSA) and R2 (MOPS buffer, EMSE, cholesterol esterase, cholesterol oxidase, peroxidase, BSA). Sensing: photometric measurement of red-purple dye intensity. Connectivity: designed for Roche/Hitachi cobas c systems. Software: uses Roche-validated biometric regression analysis tool for linearity verification.

Indications for Use

Indicated for quantitative determination of LDL-cholesterol in human serum and plasma for the diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Regulatory Classification

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 SUMMARY

510(k) #: k143691

This 510(k) was reviewed under 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.