HDL-Cholesterol Gen.4

K162593 · Roche Diagnostics Operations (Rdo) · LBS · Oct 19, 2016 · Clinical Chemistry

Device Facts

• Record ID: K162593
• Device Name: HDL-Cholesterol Gen.4
• Applicant: Roche Diagnostics Operations (Rdo)
• Product Code: LBS · Clinical Chemistry
• Decision Date: Oct 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems. 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.

Device Story

Homogeneous enzymatic colorimetric assay; utilizes polyanions and detergent to form water-soluble complexes with non-HDL lipoproteins (LDL, VLDL, chylomicrons), blocking their reaction with cholesterol esterase (CHER) and cholesterol oxidase (CHOD). HDL-cholesterol reacts with CHER and CHOD to produce hydrogen peroxide; peroxidase reacts with 4-amino-antipyrine and EMSE to form a dye. Color intensity, measured photometrically, is directly proportional to HDL-cholesterol concentration. Used in clinical laboratories on Roche/Hitachi cobas c systems; operated by laboratory technicians. Output provides quantitative HDL-cholesterol concentration (mg/dL) to assist clinicians in diagnosing and managing lipid disorders, atherosclerosis, and metabolic diseases.

Clinical Evidence

Bench testing only. Performance validated via precision (CLSI EP5-A3), LoB/LoD/LoQ (CLSI EP17-A2), linearity (CLSI EP6-A), and interference studies (hemolysis, lipemia, icterus, triglycerides, and drugs). Method comparison against predicate (n=111) showed Passing Bablok regression y = 0.956x - 0.949 (r=0.995). Matrix comparison confirmed performance across serum, plasma (Li-heparin, K2/K3-EDTA), and gel separation tubes.

Technological Characteristics

Homogeneous enzymatic colorimetric assay. Reagents include TAPSO/Bis-Tris buffers, cholesterol esterase, cholesterol oxidase, peroxidase, 4-amino-antipyrine, EMSE, polyanions, and detergents. Photometric detection principle. Designed for use on Roche/Hitachi cobas c systems. Measuring range 3.09-150 mg/dL. Refrigerated storage (2-8°C).

Indications for Use

Indicated for quantitative determination of HDL-cholesterol in human serum and plasma for patients requiring assessment of lipid disorders, including diabetes mellitus, atherosclerosis, and liver or 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) #: K162593

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.