(16 days)
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.
Not Found
This is a 510(k) premarket notification for an in vitro diagnostic device, the diaDexus PLAC™ test, which is an enzyme immunoassay. The information provided in the document focuses on the regulatory aspects of the device's clearance and does not contain the details requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a clinical study proving device performance.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance letter, not a clinical study report.
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).