BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

K963213 · Boehringer Mannheim Corp. · LBS · Oct 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963213
• Device Name: BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
• Applicant: Boehringer Mannheim Corp.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Boehringer Mannheim Direct HDL is intended for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

Device Story

In vitro diagnostic assay for quantitative HDL-C measurement in serum/plasma; utilizes PEG-modified cholesterol esterase and cholesterol oxidase enzymes with sulfated cyclodextrin; selective catalytic activity favors HDL over LDL, VLDL, and chylomicrons; performed in clinical laboratory settings; provides numerical concentration values to clinicians for lipid profile assessment and cardiovascular risk evaluation.

Clinical Evidence

Bench testing only. Method comparison study (n=110) vs. liquid HDL cholesterol assay showed slope 1.02, intercept 0.55, r=0.95 over range 4.8-74.4 mg/dl. Lower detection limit 3 mg/dl; linearity 0-185 mg/dl. Interference testing showed improved resistance to hemoglobin (>1000 mg/dl) and bilirubin (>65 mg/dl) compared to predicate.

Technological Characteristics

Enzymatic colorimetric assay; utilizes PEG-modified cholesterol esterase and cholesterol oxidase; sulfated cyclodextrin reagent; liquid-stable format; standalone diagnostic reagent system.

Indications for Use

Indicated for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma samples.

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.

Predicate Devices

• Boehringer Mannheim HDL Cholesterol

Submission Summary (Full Text)

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OCT 23 1996
510(k) Summary
K963013

Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1) Submitter name, address, contact
Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: John D. Stevens, RAC
Date Prepared: August 14, 1996

2) Device name
Proprietary name: Boehringer Mannheim Direct HDL-Cholesterol
Common name: HDL test

Classification name: LDL and VLDL precipitation, cholesterol via esterase-oxidase, HDL

3) Predicate device
We claim substantial equivalence to the Boehringer Mannheim HDL Cholesterol

4) Device Description
The Direct HDL test principle use PEG-modified enzymes and sulfated cyclodextrin. When cholesterol esterase and cholesterol oxidase enzymes are modified by PEG, they show selective catalytic activities toward lipoprotein fractions, with the reactivity increasing in the order LDL < VLDL ≈ chylomicrons < HDL.

5) Intended use
Boehringer Mannheim Direct HDL is intended for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

Continued on next page

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510(k) Summary, Continued

6) Comparison to predicate device, (cont.)

Performance Characteristics:

| Feature | Direct HDL | HDL Cholesterol |
| --- | --- | --- |
| Lower Detection Limit | 3 mg/dl | 3 mg/dl |
| Linearity | 0 - 185 mg/dl | 3 - 150 mg/dl |
| Method Comparison | vs. HDL Cholesterol liquid (Passing-Bablock)
n = 110
slope = 1.02
intercept = 0.55
Sy.x = 3.009
r = 0.95
range = 4.8 - 74.4 | vs. HDL Cholesterol powder (Passing-Bablock)
n = 75
slope = 1.008
intercept = 0.392
Sy.x = 0.597
r = 0.999
range = 6.6 - 125.6 |
| Interfering substances | hemoglobin > 1000 mg/dl
bilirubin > 65 mg/dl
lipemia > 600 mg/dl | hemoglobin > 79 mg/dl
bilirubin > 4 mg/dl
lipemia - not tested |