(97 days)
Not Found
No
The device description details a turbidimetric immunoassay and standard curve interpolation using "appropriate calibration curve fitting software," which is a standard analytical technique, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts in the summary.
No
The device is used for diagnostic purposes (measuring Lp-PLA2 levels to aid in predicting risk for cardiovascular disease and stroke), not for treating or rehabilitating patients.
Yes
The intended use states that the kit is "an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis," indicating it is used to help diagnose or assess disease risk.
No
The device description clearly outlines physical components including reagents, calibrators, and controls, which are used in a turbidimetric immunoassay. While software is mentioned for curve fitting, the core of the device is a physical test kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the PLAC® Test Reagent Kit is for the "quantitative determination of Lp-PLA2... in human plasma or serum on automated clinical chemistry analyzers, 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 clearly indicates that the test is performed in vitro (outside the body) on human specimens (plasma or serum) to provide information for diagnostic purposes (aiding in predicting risk).
- Device Description: The description details reagents, calibrators, and controls used to measure a substance (Lp-PLA2) in serum or plasma samples. This aligns with the nature of an in vitro diagnostic test.
- Methodology: The test uses a turbidimetric immunoassay, a common technique for in vitro diagnostic testing.
- Target Specimen: The test is performed on human plasma or serum, which are biological specimens collected from the body for in vitro analysis.
- Clinical Chemistry Analyzers: The test is designed for use on automated clinical chemistry analyzers, which are standard equipment in clinical laboratories for performing in vitro diagnostic tests.
- Calibrators and Controls: The inclusion of calibrators and controls is typical for quantitative in vitro diagnostic assays to ensure accuracy and quality control.
- Performance Studies: The document includes details on analytical performance (sensitivity, precision, linearity, interfering substances, method comparison), which are standard evaluations for IVD devices.
All these elements strongly indicate that the PLAC® Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma or serum on automated clinical chemistry analyzers, 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.
The PLAC® Test Calibrator Kit is intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 by the PLAC® Test Reagent Kit.
The Lp-PLA2 Control Kit is intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test Reagent Kit, a turbidimetric immunoassay for the quantitative determination of Lp-PLA2.
Product codes
NOE, JIT, JJX
Device Description
The diaDexus PLAC® Test assay consists of separately packaged reagents, calibrators and controls for the measurement of Lp-PLA2 in serum or plasma on automated clinical chemistry analyzers.
- PLAC® Test Reagent Kit .
- R1 Tris-based buffer solution
- R2 Suspension of latex microparticles coated with mouse monoclonal antibodies specific to Lp-PLA2 (2C10 and 4B4).
- PLAC® Test Calibrator Kit .
Five level set of Lp-PLA2 calibrators made with recombinant Lp-PLA2 in a protein stabilizing buffer and used to calibrate the PLAC assay.
- Lp-PLA2 Control Kit .
Two level set of Lp-PLA2 controls made with recombinant Lp-PLA2 in a protein stabilizing buffer and used for quality control of the PLAC assay.
The diaDexus PLAC® Test is based on turbidimetric immunoassay technology utilizing two Lp-PLA2-specific monoclonal antibodies (2C10 and 4B4) coated to latex microparticles. A set of Lp-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 LD-PLA2 in each sample and control is then interpolated from the standard curve using a spline curve fit with appropriate calibration curve fitting software. The kit expiration date and storage conditions are indicated on the package.
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
Professional laboratory
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
Not Found
Summary of Performance Studies
Sensitivity: The minimum detection limit is 4.0 ng/mL, as calculated by interpolation of the mean plus two standard deviations of 20 replicates of the 0 ng/mL Lp-PLA2 calibrator from the standard curve.
Precision: Intra-assay precision (n=80) ranged from 1.6 %CV to 2.4 %CV throughout assay range (69 to 450 ng/mL). Total precision (n=80) ranged from 1.8 %CV to 3.2 %CV throughout assay range (69 to 450 ng/mL).
Linearity/Assay Range: The average recovery in linearity experiments was 97%, demonstrating linearity of samples over a range of 96 to 472 ng/mL Lp-PLA2.
Interfering Substances: No appreciable interference from the addition of the following substances was observed at the noted concentrations: Bilirubin 20 mg/dL, 500 mg/dL Cholesterol, Hemoglobin 10,000 mg/dL, Triglycerides 3000 mg/dL, Total Albumin* ~6500 mg/dL. * 2.5 g/dL albumin added to plasma pool of presumptively 4 g/dL albumin.
Method Comparison: The turbidimetric immunoassay PLAC Test compared to the cleared PLAC Test (ELISA method) in a correlation study, and analyzed by linear regression, resulted in a correlation coefficient of r = 0.95, with a slope of 1.02.
Clinical Performance: No new clinical data were generated.
Key Metrics
Sensitivity: 4.0 ng/mL
Precision: Intra-assay 1.6 %CV to 2.4 %CV; Total precision 1.8 %CV to 3.2 %CV
Linearity Recovery: 97%
Method Comparison Correlation Coefficient: r = 0.95
Method Comparison Slope: 1.02
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: __K072599
General Information
Name and Address of Applicant diaDexus, Inc. 343 Oyster Point Blvd. South San Francisco, CA 94080
DEC 2 0 2007
Contact Person Julie Blacklock 650-246-6400 Telephone 650-246-6499 Facsimile
Date Prepared September 13, 2007
Trade Name
PLAC® Test Reagent Kit PLAC® Test Calibrator Kit Lp-PLA2 Control Kit
Common Name
Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 (Lipoprotein-Associated Phospholipase A2) in Human Plasma or Serum
Calibrators for use with Lp-PLA2 Turbidimetric Immunoassay
Controls for use with Lp-PLA2 Turbidimetric Immunoassay
Classification Name
TEST, SYSTEM, IMMUNOASSAY, LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 (21 CFR 866.5600, Product Code NOE)
CALIBRATOR, SECONDARY (21 CFR 862.1150, Product Code JIT)
LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL (21 CFR 866.5600, Product Code DFC)
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Legally Marketed Device to which Equivalency is Claimed
PLAC® Test (K062234)
Description of Device
The diaDexus PLAC® Test assay consists of separately packaged reagents, calibrators and controls for the measurement of Lp-PLA2 in serum or plasma on automated clinical chemistry analyzers.
- PLAC® Test Reagent Kit .
- R1 Tris-based buffer solution
- R2 Suspension of latex microparticles coated with mouse monoclonal antibodies specific to Lp-PLA2 (2C10 and 4B4).
- PLAC® Test Calibrator Kit .
Five level set of Lp-PLA2 calibrators made with recombinant Lp-PLA2 in a protein stabilizing buffer and used to calibrate the PLAC assay.
- Lp-PLA2 Control Kit .
Two level set of Lp-PLA2 controls made with recombinant Lp-PLA2 in a protein stabilizing buffer and used for quality control of the PLAC assay.
The diaDexus PLAC® Test is based on turbidimetric immunoassay technology utilizing two Lp-PLA2-specific monoclonal antibodies (2C10 and 4B4) coated to latex microparticles. A set of Lp-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 LD-PLA2 in each sample and control is then interpolated from the standard curve using a spline curve fit with appropriate calibration curve fitting software. The kit expiration date and storage conditions are indicated on the package.
Characterization of Rare Reagents
Antigen
The antigen used in the diaDexus turbidimetric immunoassay PLAC® Test is purified recombinant Lp-PLA2 (DDX-RA). Antigen preparations were characterized using SDSpolyacrylamide 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 (2C10 and 4B4) used in the preparation of the coated microparticles were characterized for purity and reactivity in a series of procedures including Paragon gel electrophoresis, SDS-PAGE, size exclusion
2
chromatography, isotyping and enzyme immunoassay. These results demonstrated that the monoclonal antibodies bind to the Lp-PLA2 antigen quantitatively and specifically.
Intended Use Statements
REAGENT KIT
The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma or serum on automated clinical chemistry analyzers, 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.
CALIBRATOR KIT
The PLAC® Test Calibrator Kit is intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 by the PLAC® Test Reagent Kit.
CONTROL KIT
The Lp-PLA2 Control Kit is intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test Reagent Kit, a turbidimetric immunoassay for the quantitative determination of Lp-PLA22
Comparison of Technological Characteristics
The chart below describes the similarities and differences between the device and the predicate, PLAC® Test ELISA kit.
3
| | Predicate
PLAC® Test
K062234 | Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | REAGENT KIT
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.
(Calibrators included in kit.) | REAGENT KIT
The PLAC® Test Reagent Kit is a
turbidimetric immunoassay for the
quantitative determination of Lp-PLA2
(lipoprotein-associated phospholipase A2) in
human plasma or serum on automated
clinical chemistry analyzers, 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.
CALIBRATOR KIT
The PLAC® Test Calibrator Kit is intended
to establish points of reference that are used
in the determination of values in the
measurement of Lp-PLA2 by the PLAC®
Test Reagent Kit. |
| Intended Use | CONTROL KIT
The Lp-PLA2 Controls are intended for
use with the diaDexus PLAC® Test, an
enzyme immunoassay for the
quantitative determination of Lp-PLA2
in human plasma and serum. The Lp-
PLA2 Controls are intended as a
Quality Control tool to monitor Lp-
PLA2 clinical laboratory results. Two
levels of Controls are provided to
monitor the performance within the
clinical range of the assay. | CONTROL KIT
The Lp-PLA2 Control Kit is intended for use
as a quality control tool to monitor the
performance within the clinical range of the
PLAC® Test Reagent Kit, a turbidimetric
immunoassay for the quantitative
determination of Lp-PLA2. |
| Methodology | Microplate Enzyme immunoassay
(ELISA) | Latex particle-enhanced turbidimetric
immunoassay (particle agglutination) |
| Detection
Method | Microplate spectrophotometer read at
450 nm | Automated clinical chemistry analyzers
read at 570 nm |
| Analyte
Sample | Lp-PLA2
Serum, EDTA-plasma, heparin-plasma | Same
Same |
| Reagent
Components | Dual monoclonal antibody sandwich
ELISA:
• anti-Lp-PLA2 mAb (2C10) coated
stripwells
• Wash Buffer
• Enzyme Conjugate : anti-Lp-
PLA2 mAb (4B4)-HRP
• TMB Substrate Solution
• Stop Solution | Two-reagent system:
• R1: Tris-based buffer solution
• R2: Suspension of anti-Lp-PLA2
(mAbs 2C10 and 4B4) coated latex
beads |
| | Predicate
PLAC® Test
K062234 | Device |
| Calibration | Six calibrators made with recombinant
Lp-PLA₂ in a buffered protein matrix
(included in ELISA kit) | Five calibrators made with recombinant
Lp-PLA₂ in a buffered protein matrix (sold
separately) |
| Calibration
Levels | 0, 50, 100, 250, 500, 1000 ng/mL | 0, 50, 100, 250, 500 ng/mL |
| Quality
Control | • 2 levels
• Recombinant Lp-PLA₂ in a
buffered protein matrix | Same |
| Risk to
Patients | Minimal risk | Same |
| Laboratory
Environment | Professional laboratory | Same |
.
.
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Performance Characteristics - Analytical
Sensitivity
The minimum detection limit is 4.0 ng/mL, as calculated by interpolation of the mean plus two standard deviations of 20 replicates of the 0 ng/mL Lp-PLA2 calibrator from the standard curve.
Precision
Intra-assay precision (n=80) ranged from 1.6 %CV to 2.4 %CV throughout assay range (69 to 450 ng/mL).
Total precision (n=80) ranged from 1.8 %CV to 3.2 %CV throughout assay range (69 to 450 ng/mL).
Linearity/Assay Range
The average recovery in linearity experiments was 97%, demonstrating linearity of samples over a range of 96 to 472 ng/mL Lp-PLA2.
5
Interfering Substances
No appreciable interference from the addition of the following substances was observed at the noted concentrations:
- . Bilirubin 20 mg/dL
- 500 mg/dL Cholesterol ●
- Hemoglobin 10,000 mg/dL .
- . Triglycerides 3000 mg/dL
- Total Albumin* ~6500 mg/dL .
-
- 2.5 g/dL albumin added to plasma pool of presumptively 4 g/dL albumin
Method Comparison
The turbidimetric immunoassay PLAC Test compared to the cleared PLAC Test (ELISA method) in a correlation study, and analyzed by linear regression, resulted in a correlation coefficient of r = 0.95, with a slope of 1.02.
Performance Characteristics - Clinical
No new clinical data were generated.
Conclusions
The latex-particle enhanced turbidimetric immunoassay PLAC Test has the same performance characteristics and clinical utility as the cleared enzyme immunoassay PLAC Test (K062234), and therefore is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
diaDexus, Inc. c/o Robert L. Wolfert, Ph.D. Executive Vice President of Diagnostics 343 Oyster Point Blvd. South San Francisco, CA 94080
DEC 2 0 2007
K072599 Re:
Trade/Device Name: PLAC® Test Reagent Kit PLAC® Test Calibrator Kit Lp-PLA2 Control Kit
Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: NOE, JIT, JJX Dated: December 11, 2007 Received: December 12, 2007
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).
7
Page 2 -
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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 ·
8
Indications for Use
510(k) Number (if known):
Device Name: PLAC® Test Reagent Kit PLAC® Test Calibrator Kit Lp-PLA2 Control Kit
Indication For Use:
The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma or serum on automated clinical chemistry analyzers, 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.
The PLAC® Test Calibrator Kit is intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 by the PLAC® Test Reagent Kit.
The Lp-PLA2 Control Kit is intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test Reagent Kit, a turbidimetric immunoassay for the quantitative determination of Lp-PLA2.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072599