Direct HDL Cholesterol (HDL)

K153435 · Randox Laboratories, Ltd. · LBS · Jan 8, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153435
• Device Name: Direct HDL Cholesterol (HDL)
• Applicant: Randox Laboratories, Ltd.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

Device Story

Direct HDL Cholesterol (HDL) is an in vitro diagnostic reagent kit for quantitative measurement of HDL cholesterol in serum and plasma. Used in clinical laboratories on RX Daytona plus and RX Imola systems. Principle of operation: two-step enzymatic endpoint method. Step 1: elimination of chylomicron, VLDL, and LDL cholesterol via cholesterol esterase, cholesterol oxidase, and catalase. Step 2: specific measurement of HDL cholesterol released by detergents in Reagent 2, producing a quinone imine dye measured at 600 nm. Intensity is directly proportional to cholesterol concentration. Results assist clinicians in diagnosing lipid disorders, diabetes, atherosclerosis, and renal/liver diseases, and assessing cardiovascular risk. Device is operated by laboratory technicians. Output is a quantitative concentration value (mg/dL) used to inform clinical management of lipid profiles.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=80, CVs 3.4-4.6%). Linearity per CLSI EP6-A (r=0.998, range 20-129 mg/dL). LoD 0.73 mg/dL; LoQ 7.1 mg/dL. Interference testing showed no significant interference for hemoglobin, bilirubin, triglycerides, Intralipid, or ascorbic acid. Method comparison (N=103) against predicate yielded Y=1.01x-0.75 (r=0.994). Matrix comparison (N=45) between serum and lithium heparin plasma yielded Y=0.99x+2.18 (r=0.993).

Technological Characteristics

Enzymatic endpoint assay. Reagents: R1 (Good's buffer, cholesterol esterase, cholesterol oxidase, catalase, ascorbate oxidase) and R2 (Good's buffer, 4-aminoantipyrine, peroxidase, sodium azide, surfactants). Photometric detection at 600 nm. Standalone reagent kit for use on automated clinical chemistry analyzers (RX Daytona plus/RX Imola).

Indications for Use

Indicated for the quantitative in vitro determination of HDL Cholesterol in serum and plasma for patients requiring assessment of lipid disorders, diabetes mellitus, atherosclerosis, liver/renal diseases, and cardiovascular disease risk. Rx Only.

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) #: K153435

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.