MODIFICATION TO DIADEXUS PLAC TEST

K040101 · Diadexus, Inc. · NOE · Feb 5, 2004 · Immunology

Device Facts

• Record ID: K040101
• Device Name: MODIFICATION TO DIADEXUS PLAC TEST
• Applicant: Diadexus, Inc.
• Product Code: NOE · Immunology
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Indications for Use

The diaDexus PLAC™ test is an enzyme immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein - associated phospholipase A2) in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease.

Device Story

The diaDexus PLAC test is an enzyme immunoassay (EIA) used to measure lipoprotein-associated phospholipase A2 (Lp-PLA2) levels in human plasma. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The test provides a quantitative result that clinicians use alongside standard clinical evaluations and risk assessments to help predict a patient's risk for coronary heart disease. The assay process involves standard immunoassay techniques to detect the specific enzyme in plasma samples, providing objective data to support cardiovascular risk stratification.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Immunometric assay technology; liquid-stable calibrators; room temperature operation. Kit components reduced by removing reconstitution buffer and sample diluent. No changes to fundamental scientific technology.

Indications for Use

Indicated for quantitative determination of Lp-PLA2 in human plasma to aid in predicting coronary heart disease risk in conjunction with clinical evaluation and patient risk assessment.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K040101

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 (labeling changes are permitted as long as they do not affect the intended use).

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 re-optimization of the test components so that the test is easier to use. The calibrators have been reformulated to be stable in liquid form and the sample pre-dilution step has been eliminated. The changes to the test remove two components from the kit (re-constitution buffer and sample diluent) and eliminate re-constitution and sample pre-dilution. Also, the test is performed at room temperature, thus eliminating the need for ice baths, or equivalent.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunometric assay technology, test protocol, performance, assay principle, expected values and reagents.

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.