(40 days)
Not Found
No
The description details a standard enzyme immunoassay and mentions "appropriate calibration curve fitting software" for interpolation, which is a common statistical method and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic test used to predict risk for coronary heart disease and ischemic stroke by measuring Lp-PLA2 levels, not to treat or prevent a disease.
Yes
The device is described as an "enzyme immunoassay for the quantitative determination of Lp-PLA2...to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis." This directly indicates its use for diagnostic purposes.
No
The device description clearly outlines a physical test kit containing reagents, microwell strips, and other laboratory components, indicating it is a hardware-based diagnostic test, not software-only. While it mentions "appropriate calibration curve fitting software" for data interpolation, this software is a component used with the physical test kit, not the primary device itself.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Lp-PLA2... in human plasma and serum." This involves testing biological samples taken from the body.
- Device Description: The description details a "test kit" containing reagents, antibodies, and microwell strips designed for performing laboratory tests on these samples.
- Methodology: The test is based on a "sandwich enzyme immunoassay," a common laboratory technique for analyzing biological samples.
- Performance Studies: The performance studies describe analytical characteristics like sensitivity, linearity, precision, and correlation, which are typical evaluations for IVD devices.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
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 and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
Product codes (comma separated list FDA assigned to the subject device)
NQE
Device Description
The diaDexus PLAC® test kit contains Lp-PLA2 calibrators, monoclonal anti-Lp-PLA2 (4B4) antibody conjugated to horseradish peroxidase, monoclonal anti-Lp-PLA2 (2C10) antibody-coated microwell strips with a stripwell frame, various buffers and related reagents, and a package insert. Each stripwell can be used for performing only one set of tests (i.e. single use). One plate may accommodate up to 40 clinical samples when assayed in duplicate. The kit expiration date and storage conditions are indicated on the package. The diaDexus PLAC® test is based on the standard principle of a sandwich enzyme immunoassay using two specific monoclonal antibodies. A set of LD-PLA2 calibrators is used to plot a standard curve of absorbance (y-axis) versus Lp-PLA2 concentration in ng/mL (x-axis) from which the Lp-PLA2 concentration in the test sample can be determined. The concentration of Lp-PLA2 in each sample and control is then interpolated from the standard curve using a point-to-point curve fit with appropriate calibration curve fitting software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new clinical data was generated. The modified PLAC test has the same performance characteristics and clinical utility as the cleared PLAC test (K050523).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity (Detection Limit): The minimum detection limit is 2.4 ng/mL, as calculated by interpolation of the mean plus two standard deviations of 16 replicates of the 0 ng/mL Lp-PLA2 calibrator.
Linearity/Assay Range: 120 - 782 ng/mL
Precision: Intra-assay precision (n=80) ranged from 4.3 %CV to 6.3 %CV throughout assay range. Total precision (n=80) ranged from 5.7 %CV to 11.0 %CV throughout assay range.
Correlation: The modified PLAC test compared to the cleared PLAC test in a correlation regression resulted in an r value of 0.91 with a slope of 1.02.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
SEP 1 1 2006
diaDexus, Inc. PLAC® Test Special 510(k) K062234
510(k) Summary diaDexus PLAC® Test
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K062234
General Information
| Name and Address of Applicant: | diaDexus, Inc.
343 Oyster Point Blvd.
South San Francisco, CA 94080 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | diaDexus PLAC® test |
| Generic Name: | Enzyme Immunoassay for the Quantitative
Determination of Lp-PLA2 (Lipoprotein-
Associated Phospholipase A2) in Human
Plasma and Serum |
Intended Use
The diaDexus PLAC® test is an enzyme immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
Device Description
The diaDexus PLAC® test kit contains Lp-PLA2 calibrators, monoclonal anti-Lp-PLA2 (4B4) antibody conjugated to horseradish peroxidase, monoclonal anti-Lp-PLA2 (2C10) antibody-coated microwell strips with a stripwell frame, various buffers and related reagents, and a package insert. Each stripwell can be used for performing only one set of tests (i.e. single use). One plate may accommodate up to 40 clinical samples when assayed in duplicate. The kit expiration date and storage conditions are indicated on the package.
1
The diaDexus PLAC® test is based on the standard principle of a sandwich enzyme immunoassay using two specific monoclonal antibodies. A set of LD-PLA2 calibrators is used to plot a standard curve of absorbance (y-axis) versus Lp-PLA2 concentration in ng/mL (x-axis) from which the Lp-PLA2 concentration in the test sample can be determined. The concentration of Lp-PLA2 in each sample and control is then interpolated from the standard curve using a point-to-point curve fit with appropriate calibration curve fitting software.
Characterization of Rare Reagents
Antigen
The antigen used in the diaDexus enzyme immunoassay PLAC® test is purified recombinant Lp-PLA2 (DDX-RA). Antigen preparations were characterized using SDS-polyacrylamide gels under reducing and non-reducing conditions and Western blot analysis using an anti-Lp-PLA2 antibody, to demonstrate consistency with the molecular weight of the antigen reported in the literature.
Antibodies
The monoclonal anti-Lp-PLA2 antibodies used in the preparation of the coated microwell strips (2C10) and conjugate (4B4) were characterized for purity and reactivity in a series of procedures including Paragon gel electrophoresis, SDS-PAGE, size exclusion chromatography, isotyping and enzyme immunoassay. These results demonstrated that the monoclonal antibodies bind to the Lp-PLA2 antigen quantitatively and specifically.
Performance Characteristics - Analytical
Analytical Sensitivity (Detection Limit)
The minimum detection limit is 2.4 ng/mL, as calculated by interpolation of the mean plus two standard deviations of 16 replicates of the 0 ng/mL Lp-PLA2 calibrator.
Linearity/Assay Range
120 - 782 ng/mL
2
Interfering Substances
No appreciable interference from the addition of the following substances at the noted concentrations:
- Total Albumin ~6500 mg/dL .
- . Bilirubin 20 mg/dL
- Cholesterol . 500 mg/dL
- Hemoglobin . 1250 mg/dL
- Triglycerides � 3000 mg/dL
Precision
Intra-assay precision (n=80) ranged from 4.3 %CV to 6.3 %CV throughout assay range.
Total precision (n=80) ranged from 5.7 %CV to 11.0 %CV throughout assay range.
Correlation
The modified PLAC test compared to the cleared PLAC test in a correlation regression resulted in an r value of 0.91 with a slope of 1.02.
Performance Characteristics – Clinical
No new clinical data was generated. The modified PLAC test has the same performance characteristics and clinical utility as the cleared PLAC test (K050523).
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.
Public Health Service
SEP 1 1 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robert L. Wolfert, Ph.D. Executive Vice President of Diagnostics diaDexus, Inc. 343 Oyster Point Blvd. South San Francisco, CA 94080
Re:
K062234 Trade/Device Name: diaDexus PLAC® Test Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: NOE Dated: August 1, 2006 Received: August 23, 2006
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).
Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized lines representing its wings and body.
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K062234
Device Name:
diaDexus PLAC® 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 and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K062234
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