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

Intended 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 2004

Robert L. Wolfert, Ph.D. Vice President of Diagnostics diaDexus, Inc. 343 Oyster Point Blvd South San Francisco, CA 94080

Re: k040101

> Trade/Device Name: diaDexus PLAC'M test Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: NOE Dated: January 19, 2004 Received: January 21, 2004

Dear Dr. Wolfert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Jean M. Cooper MS, DVM.

Yean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K040101 "Special" |
|---------------------------|----------------------------------|
| Device Name: | diaDexus PLAC ^TM test |

## 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.

Please do not WRITE BELOW THIS LINE - CONTINUE on another Page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benam for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K040101

Prescription Use
(Per 21 CFR 801.109
or
Over-The-Counter Use