(186 days)
Not Found
No
The device description details a turbidimetric immunoassay and standard curve fitting using a spline curve fit, which are standard analytical techniques and do not indicate the use of AI or ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic (IVD) test used to measure Lp-PLA2 levels as an aid in predicting risk, not to directly treat or provide therapy.
Yes
The device is intended to be used "as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis," which is a diagnostic purpose.
No
The device is a reagent kit consisting of physical components (buffer solution, microparticles) used in a laboratory setting on automated clinical chemistry analyzers. While it mentions "appropriate calibration curve fitting software," the primary device is the physical reagent kit, not the software 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 or serum". This is a classic characteristic of an in vitro diagnostic test, as it analyzes biological samples outside of the body.
- Device Description: The description details reagents, calibrators, and controls used for measuring a substance in serum or plasma. These are components of an IVD kit.
- Technology: The use of a "turbidimetric immunoassay" is a common method employed in IVD tests to measure the concentration of specific substances in biological fluids.
- Performance Studies: The inclusion of method comparison and imprecision studies, comparing the device to a "Predicate Method" (another IVD kit), further confirms its nature as an IVD.
The entire description points to a product designed to perform a diagnostic test on biological samples in a laboratory setting, which is the definition of 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 serum or plasma 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.
Product codes
NOE
Device Description
The PLAC® Test Reagent Kit 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 Buffer solution with protein stabilizers
- R2 Suspension of polymeric microparticles coated with mouse monoclonal antibodies specific to Lp-PLA2 (2C10 and 4B4).
The PLAC® Test Reagent Kit is based on turbidimetric immunoassay technology utilizing two Lp-PLA3-specific monoclonal antibodies (2C10 and 4B4) coated to polymeric 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 Lp-PLA, 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Assay equivalence is demonstrated through method comparison and imprecision studies.
Methods Comparison Data:
- Predicate Method: PLAC® Test ELISA Kit
- Slope: 1.09
- Intercept: -1.7
- R: 0.92
- n: 742
- Acceptance Criteria: Slope 0.9 to 1.1, Intercept ≤ 50 ng/mL, r ≥0.90
- Modified Product: PLAC® Test Reagent Kit
Imprecision Testing:
- Serum 1: Mean Concentration Lp-PLA2 (ng/mL) 56.2; Intra-assay %CV n=40 2.5%; Inter-assay %CV n=40 4.6%; Total Assay %CV n=80 5.3%
- Serum 2: Mean Concentration Lp-PLA2 (ng/mL) 250.1; Intra-assay %CV n=40 1.0%; Inter-assay %CV n=40 2.7%; Total Assay %CV n=80 2.9%
- Buffer Control 1: Mean Concentration Lp-PLA2 (ng/mL) 191.2; Intra-assay %CV n=40 0.7%; Inter-assay %CV n=40 0.9%; Total Assay %CV n=80 1.4%
- Buffer Control 2: Mean Concentration Lp-PLA2 (ng/mL) 370.8; Intra-assay %CV n=40 1.0%; Inter-assay %CV n=40 0.7%; Total Assay %CV n=80 1.6%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
KIDBS 3
1.0 Submitted By:
Lynne McBride Director of Regulatory Affairs diaDexus 343 Oyster Point Blvd South San Francisco, California 94080 Telephone: 650-246-6423 Fax: 650-246-6439
JAN - 3 2011
2.0 Date Submitted
June 30, 2010
3.0 Device Name(s):
PLAC® Test Reagent Kit
4.0 Classification
Reagent:
866.5600 Low-density lipoprotein immunological test system NOE; test, system, immunoassay, lipoprotein-associated phospholipase a2
5.0 Legally Marketed Device
| Predicate | Predicate
Manufacturer | Docket
Number |
|----------------------|---------------------------|------------------|
| PLAC® Test ELISA Kit | diaDexus | K062234 |
6.0 Device Description
The PLAC® Test Reagent Kit 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 Buffer solution with protein stabilizers
- R2 Suspension of polymeric microparticles coated with mouse monoclonal antibodies specific to Lp-PLA2 (2C10 and 4B4). .
1
The PLAC® Test Reagent Kit is based on turbidimetric immunoassay technology utilizing two Lp-PLA3-specific monoclonal antibodies (2C10 and 4B4) coated to polymeric 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 Lp-PLA, 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.
7.0 Intended Use
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.
8.0 Similarities and Differences to the Predicate
| Similarities | ||
|---|---|---|
| Item | Predicate - K062234 PLAC Test ELISA Kit | Modified - PLAC Test Reagent Kit |
| Product Intended | ||
| Use/Indications | The diaDexus PLAC® Test ELISA Kit 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. | 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. | ||
| Key Reagent | ||
| Components | Anti-PLA2 (2C10) and anti-PLA2 (4B4) | same |
| Calibrators Matrix | Recombinant Lp-PLA2 antigen in a protein | |
| stabilizing diluent | Same | |
| Control Matrix | Recombinant Lp-PLA2 antigen in a protein | |
| stabilizing diluent | same | |
| Controls Levels | 2 | same |
Similarities
2
| Differences | ||
|---|---|---|
| Item | Predicate - K062234 PLAC ELISA Kit | Modified - PLAC Test Reagent Kit |
| Measuring range | 0-1000 ng/mL | 25 to 500 ng/mL |
| Methodology | Dual monoclonal antibody sandwich ELISA read | |
| at 450 nm on a microwell plate reader | Immuno- Turbidimetric assay read at 570 | |
| nm on clinical chemistry analyzers | ||
| Reagent | ||
| Configuration | Anti-Lp-PLA₂ mAb (2C10) coated stripwellsWash bufferEnzyme conjugate anti-Lp-PLA₂ mAb (4B4)-HRPTMB substrateStop solution | Two reagent system |
| R1- Buffer solution with protein stabilzers | ||
| R2- antibody coated microparticles (mAbs 2C10 and 4B4) | ||
| Kit Configuration | Reagent, calibrators and controls all in one kit | Reagent, calibrators and controls in |
| separate kits. | ||
| Calibrator Levels | 6 levels - 0,50,100, 250, 500, 1000 ng/ml | 5 levels - 0, 50, 100, 250, 500 ng/ml |
| Reference Range | Median value is 235 ng/ml per population | |
| studied in 2006 | Median value is 152 ng/mL per population | |
| studied in 2010 | ||
| Samples Types | Serum, EDTA, Heparin | Serum, K₂EDTA |
9.0 Summary of Performance Data
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Assay equivalence is demonstrated through method comparison and imprecision studies.
Methods Comparison Data
| Predicate
Method | Slope | Intercept | R | n | Acceptance Criteria | Modified
Product |
|-------------------------|-------|-----------|------|-----|-----------------------------------------------------|---------------------------|
| PLAC® Test
ELISA Kit | 1.09 | -1.7 | 0.92 | 742 | Slope 0.9 to 1.1
Intercept ≤ 50 ng/mL
r ≥0.90 | PLAC® Test
Reagent Kit |
3
Imprecision Testing
| Samples | Mean Concentration
Lp-PLA2 (ng/mL) | Intra-assay
%CV n=40 | Inter-assay
%CV n=40 | Total Assay
%CV n=80 |
|------------------|---------------------------------------|-------------------------|-------------------------|-------------------------|
| Serum 1 | 56.2 | 2.5% | 4.6% | 5.3% |
| Serum 2 | 250.1 | 1.0% | 2.7% | 2.9% |
| Buffer Control 1 | 191.2 | 0.7% | 0.9% | 1.4% |
| Buffer Control 2 | 370.8 | 1.0% | 0.7% | 1.6% |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wings, representing service, science, and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
diaDexus, Inc. c/o Nina Peled, PhD Regulatory Affairs Consultant 343 Oyster Point Blvd South San Francisco, CA 94080
JAN 0 3 2011
Re: ' K101853 PLAC® Test Reagent Kit Trade/Device Name: Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: NOE Dated: November 23, 2010 Received: November 24, 2010
Dear Dr. Peled,
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).
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.
5
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
JAN - 3 2011
Indications for Use Form
510(k) Number (if known): ≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤≤
Device Name:
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 serum or plasma 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.
| 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101853