HDL-CHOLESTEROL PLUS 2ND GENERATION

K033610 · Roche Diagnostics Corp. · LBS · Dec 5, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033610
• Device Name: HDL-CHOLESTEROL PLUS 2ND GENERATION
• Applicant: Roche Diagnostics Corp.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Dec 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers.

Device Story

HDL-Cholesterol plus 2nd generation is an in-vitro diagnostic assay for use on automated clinical chemistry analyzers. The device uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons, rendering them resistant to PEG-modified enzymes. HDL-cholesterol is then determined enzymatically via cholesterol esterase and cholesterol oxidase coupled with PEG. The reaction produces a blue quinoneimine dye, the intensity of which is measured photometrically and is directly proportional to the HDL-cholesterol concentration. The assay is intended for clinical laboratory use to assist physicians in diagnosing and managing lipid-related conditions, including atherosclerosis, diabetes, and liver or renal diseases.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of modified reagents and matrix compatibility.

Technological Characteristics

In vitro diagnostic reagents (R1, R2) with modified buffer formulation; supports NH4 heparin plasma matrix. Fundamental scientific technology unchanged.

Indications for Use

Indicated for the direct quantitative determination of HDL-C in human serum and plasma to aid in the diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and liver/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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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of a minor name change, NH4 heparin plasma as an acceptable matrix, and changes to the buffer formulation of the two reagents R1 and R2.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and formulation.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.