(16 days)
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No
The summary describes a laboratory test (enzyme immunoassay) for a specific biomarker. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic test for predicting risk and does not provide therapy or treatment.
Yes
The device is used "as an aid in predicting risk for coronary heart disease," which is a diagnostic purpose.
No
The 510(k) summary describes a laboratory test (enzyme immunoassay) for measuring a specific substance in human plasma. This involves physical reagents and laboratory equipment, not just software.
Yes, based on the provided information, the diaDexus PLAC™ test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test is for the "quantitative determination of Lp-PLA2... in human plasma". This indicates that the test is performed on a biological sample (plasma) taken from the human body.
- Purpose: The purpose is to be used "as an aid in predicting risk for coronary heart disease". This is a diagnostic purpose, providing information about a patient's health status or risk.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The diaDexus PLAC™ test fits this definition.
N/A
Intended Use / 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.
Product codes
NOE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
2
| 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