(186 days)
Not Found
No
The device is an enzyme assay that measures the rate of a chemical reaction spectrophotometrically and calculates the result based on a standard curve. There is no mention of AI or ML in the description or performance studies.
No.
This device is an in vitro diagnostic (IVD) test designed to measure Lp-PLA2 activity as an aid in predicting risk of coronary heart disease. It does not treat or alleviate a disease, but rather provides diagnostic information.
Yes
The device is described as an "enzyme assay for the in vitro quantitative determination of Lp-PLA2" activity in blood samples and is "to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD)". This clearly indicates it provides information to aid in diagnosis or risk assessment of a disease.
No
The device is described as consisting of reagents, calibrators, and controls for an enzyme assay, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the PLAC® Test for Lp-PLA2 Activity is an "enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum". The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The test is performed on biological samples (EDTA-plasma and serum) taken from the human body.
- Purpose: The test is used to measure a specific analyte (Lp-PLA2 activity) in these samples to provide information that aids in predicting the risk of coronary heart disease. This is a diagnostic purpose.
- Device Description: The description details the reagents, calibrators, and controls used to perform the test on automated clinical chemistry analyzers, which are typical components of an IVD system.
- Clinical Laboratory Setting: The intended user and care setting are described as "Automated clinical chemistry analyzers in a clinical laboratory setting," which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.
The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity.
Product codes
NOE, JIT, JJX
Device Description
The PLAC® Test for Lp-PLA2 Activity consists of the reagents, Lp-PLA2 Activity Test Calibrators and Lp-PLA2 Test Controls for the measurement of Lp-PLA2 activity in EDTA-plasma or serum on automated clinical laboratory analyzers.
Lp-PLA2, in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1-myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing a colored reaction product, 4-nitrophenol. The rate of formation of 4-nitrophenol is measured spectrophotometrically for 8.5 minutes and the Lp-PLA2 activity is calculated from the rate of change in absorbance. A set of five Lp-PLA2 calibrators is used to generate a standard curve fit of change in absorbance versus Lp-PLA2 activity level in nmol/min/mL from which the sample Lp-PLA2 activity is derived.
The PLAC® Test for Lp-PLA2 Activity also includes controls. Controls should be included in each run or in accordance with the user's laboratory's quality control policies.
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
Automated clinical chemistry analyzers
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
Precision: The precision of the PLAC® Test for Lp-PLA2 Activity was evaluated on one Beckman Coulter (Olympus) AU400® Clinical Chemistry Analyzer and three (3) kit lots according to CLSI EP5-A2. Four native plasma samples, kit control low, and kit control high with known amounts of Lp-PLA2 activity values ranging from 111 to 321 nmol/min/mL were tested with 2 replicates per run, 2 runs per day for 20 days. Total precision CV's for all kit lots and test samples were
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol of medicine, with three figures representing health, services, and human needs.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DIADEXUS, INC. C/O LORRY WEAVER HUFFMAN MYRAQA, INC. 3 LAGOON DR. SUITE 280 REDWOOD SHORES CA 94065
December 15, 2014
Re: K141575 Trade/Device Name: PLAC® Test for Lp-PLA2 Activity Lp-PLA2 Activity Test Calibrators Lp-PLA2 Activity Test Controls Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: II Product Code: NOE, JIT, JJX Dated: October 30, 2014 Received: November 3, 2014
Dear Ms. Lorry Huffman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D.
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141575
Device Name PLAC® Test for Lp-PLA2 Activity
Indications for Use (Describe)
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.
The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - PLAC® Test for Lp-PLA2 Activity
1. Submitter Name:
diaDexus, Inc. 349 Oyster Point Blvd. South San Francisco, CA 94080 Contact: Emi Zychlinsky, Ph.D. Telephone: 650-246-6459
2. Correspondent/Contact
Lorry Weaver Huffman, Senior Director Myraqa, Inc. 3 Lagoon Dr., Suite 280 Redwood Shores, CA 94065 Phone: 1 (650) 730-5030 Mobile: 1 (916) 812-3047 Fax: 1 (916) 638-2647 E-mail: lorry@myraqa.com
3. Date Prepared: December 05, 2014
4. Device Name
| Trade Name (Proprietary Name): | PLAC® Test for Lp-PLA2 Activity
Lp-PLA2 Activity Test Calibrators
Lp-PLA2 Activity Test Controls |
|--------------------------------|--------------------------------------------------------------------------------------------------------|
| Common Name (Usual Name): | PLAC Activity |
| Panel: | Immunology |
| Measurand: | Lipoprotein-Associated Phospholipase A2 (Lp-
PLA2) |
| Sample Type: | EDTA-plasma or serum |
| Type of Test: | Enzyme activity rate of change using a standard
curve |
4
| Product | Regulation | Description | Product
Code |
|--------------------------------------|------------|-----------------------------------------------------------------------------|-----------------|
| PLAC® Test for
Lp-PLA2 Activity | 866.5600 | Test, system,
immunoassay,
lipoprotein-associated
phospholipase A2 | NOE |
| Lp-PLA2 Activity
Test Calibrators | 862.1150 | Calibrators, Secondary | JIT |
| Lp-PLA2 Activity
Test Controls | 862.1660 | Quality Control Material
(assayed and unassayed) | JJX |
5. Predicate Devices: K030477 - PLAC® Test
6. Device Description:
The PLAC® Test for Lp-PLA2 Activity consists of the reagents, Lp-PLA2 Activity Test Calibrators and Lp-PLA2 Activity Test Controls for the measurement of Lp-PLA2 activity in EDTA-plasma or serum on automated clinical laboratory analyzers.
Lp-PLA2, in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing a colored reaction product, 4-nitrophenol. The rate of formation of 4-nitrophenol is measured spectrophotometrically for 8.5 minutes and the Lp-PLA2 activity is calculated from the rate of change in absorbance. A set of five Lp-PLA2 calibrators is used to generate a standard curve fit of change in absorbance versus Lp-PLA2 activity level in nmol/min/mL from which the sample Lp-PLA2 activity is derived.
The PLAC® Test for Lp-PLA2 Activity also includes controls. Controls should be included in each run or in accordance with the user's laboratory's quality control policies.
7. Intended Use:
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
5
The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.
The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity.
8. Summary of Technological Characteristics Compared to the Predicate Device:
The technological characteristics of the predicate device diaDexus PLAC® Test, 510(k) number K030477, differs in detection method from the device subject of this 510(k), diaDexus PLAC® Test for Lp-PLA2 Activity. In principle, both assays measure Lp-PLA3, however the predicate device measures concentration (ng/mL) and the subject assay measures enzymatic activity (nmol/min/mL).
The PLAC® Test for Lp-PLA2 Activity is for in vitro diagnostic use for quantitative determination of Lp-PLA2 activity. In the PLAC® Test for Lp-PLA2 Activity, Lp-PLA2 in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1-myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing 4-nitrophenyl succinate. The latter is immediately further hydrolyzed to produce the colored reaction product, 4-nitrophenol. spectrophotometrically at 410 nm and the Lp-PLA2 activity is calculated from the rate of change in absorbance. The predicate PLAC® Test is an ELISA immunoassay based on the principle of a sandwich enzyme immunoassay using two specific monoclonal antibodies for the direct measurement of Lp-PLA2 concentration. Absorbance of the colored by-product from the enzymatic turnover of the substrate by the enzyme labeled on the detection antibody is measured spectrophotometrically at 450 nm and is directly proportional to the concentration of Lp-PLA2 present.
The performance testing provided in this 510(k) is sufficient to demonstrate that PLAC® Test for Lp-PLA2 Activity is substantially equivalent to the legally marketed predicate device, diaDexus PLAC® Test, K030477. The comparison of assays similarities and differences are shown in Table 1.
6
| Attribute | (Predicate Devices)
PLAC® Test (K030477) | (Subject Device)
PLAC® Test for Lp-PLA2 Activity |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REAGENT KIT
Intended Use | The 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. | The PLAC® Test for Lp-PLA2
Activity is an enzyme assay for
the in vitro quantitative
determination of Lp-PLA2
(lipoprotein-associated
phospholipase A2) activity in
EDTA-plasma and serum on
automated clinical chemistry
analyzers. Lp-PLA2 activity is
to be used in conjunction with
clinical evaluation and patient
risk assessment as an aid in
predicting risk of coronary heart
disease (CHD) in patients with
no prior history of
cardiovascular events. |
| REAGENT KIT
Classification Code | NOE - Test, system,
immunoassay, lipoprotein-
associated phospholipase A2 | Same |
| CALIBRATORS
Intended Use | The PLAC® Test Calibrators
are intended to establish
points of reference that are
used in the determination of
values in the measurement of
Lp-PLA2 by the PLAC® Test. | The Lp-PLA2 Activity Test
Calibrators are intended to
establish points of reference
that are used in the
determination of values in the
measurement of Lp-PLA2 by
the PLAC® Test for Lp-PLA2
Activity. |
| CALIBRATORS
Classification Code | JIT - Calibrators, Secondary | Same |
| CONTROLS
Intended Use | The Lp-PLA2 Controls are
intended for use as a quality
control tool to monitor the
performance within the
clinical range of the PLAC®
Test, an immunoassay for the
quantitative determination of
Lp-PLA2. | The Lp-PLA2 Activity Test
Controls are intended for use as
a quality control tool to monitor
the performance within the
clinical range of the PLAC®
Test for Lp-PLA2 Activity, an
enzyme assay for the
quantitative determination of
Lp-PLA2 activity. |
| Attribute | (Predicate Devices)
PLAC® Test (K030477) | (Subject Device)
PLAC® Test for Lp-PLA2
Activity |
| CONTROLS
Classification Code | JJX - Enzyme controls
(assayed and unassayed) | Same |
| Sample Source | EDTA plasma | Serum
EDTA plasma |
| Assay method | Enzyme immunoassay
(ELISA) | Enzyme kinetics activity rate
of change using a standard
curve |
| Measurement units | Concentration, ng/mL | Activity, nmol/min/mL |
| Analyte | Lp-PLA2 | Same |
| Test Reagents | • Anti-Lp-PLA2 mAb coated
stripwells
• Enzyme conjugate anti-Lp-
PLA2 mAb-HRP
• TMB substrate
• Stop solution
• Assay buffer
• Reconstitution buffer
• Sample diluent | • R1: Buffer
• R2: Lp-PLA2 Substrate, 1-
myristoyl-2-(4-
nitrophenylsuccinyl)
phosphatidylcholine |
| Calibration materials | A set of calibrators made with
recombinant Lp-PLA2 protein
in a protein matrix | A set of calibrators made with
recombinant Lp-PLA2 protein
in a protein buffered matrix |
| Control materials | 2 levels recombinant Lp-
PLA2 protein in a stabilizing
diluent | Same |
| Sample Preparation | Sample diluent is added to the
sample | No sample preparation is
required |
| Instrument reader | Microtiter plate reader | Automated clinical chemistry
analyzer |
Table 1. Comparison of Assays
7
9. Summary of Non-clinical Performance Testing as Basis for Substantial Equivalence
Studies were conducted to evaluate the performance characteristics of the PLAC® Test for Lp-PLA2 Activity. The studies include precision, analytical sensitivity (limit of detection/limit of the blank/limit of quantitation), linearity, recovery, interfering substances, specimen handling, stability, and matrix comparison.
8
Precision
The precision of the PLAC® Test for Lp-PLA2 Activity was evaluated on one Beckman Coulter (Olympus) AU400® Clinical Chemistry Analyzer and three (3) kit lots according to CLSI EP5-A2. Four native plasma samples, kit control low, and kit control high with known amounts of Lp-PLA2 activity values ranging from 111 to 321 nmol/min/mL were tested with 2 replicates per run, 2 runs per day for 20 days. Total precision CV's for all kit lots and test samples were 1 Values of 0.0 are actual calculated results rounded for values