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510(k) Data Aggregation
(97 days)
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
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.
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.
Here's a breakdown of the acceptance criteria and study information for the diaDexus PLAC® Test Reagent Kit, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Sensitivity | Equivalent to predicate (ELISA method) | Minimum detection limit: 4.0 ng/mL |
| Precision | Equivalent to predicate (ELISA method) | Intra-assay: 1.6 %CV to 2.4 %CV (throughout 69-450 ng/mL range) |
| Total precision: 1.8 %CV to 3.2 %CV (throughout 69-450 ng/mL range) | ||
| Linearity/Assay Range | Equivalent to predicate (ELISA method) | Average recovery: 97% over a range of 96 to 472 ng/mL |
| Interfering Substances | No appreciable interference from common substances at specified concentrations | No appreciable interference from Bilirubin (20 mg/dL), Cholesterol (500 mg/dL), Hemoglobin (10,000 mg/dL), Triglycerides (3000 mg/dL), Total Albumin (~6500 mg/dL) |
| Method Comparison (vs. Predicate) | High correlation (e.g., r > 0.90) and acceptable slope (e.g., close to 1.0) | Correlation coefficient (r) = 0.95; Slope = 1.02 |
Note on Acceptance Criteria: For this 510(k) submission, the primary acceptance criterion is substantial equivalence to the predicate device (PLAC® Test ELISA kit, K062234). Therefore, the acceptance criteria for the new device's performance characteristics (sensitivity, precision, linearity, interference) are implicitly that they should be comparable to or within acceptable limits relative to the established performance of the predicate device. The method comparison study directly demonstrates this by comparing the new device's results to the predicate's.
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes analytical performance studies.
- Precision study: n=80 (number of replicates for intra-assay and total precision). The data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Linearity experiments: The document mentions "linearity experiments" but does not specify the number of samples used.
- Interfering substances study: The document identifies specific interfering substances and their concentrations but does not specify the number of samples tested for this.
- Method Comparison study: The document states a "correlation study" was performed, comparing the new turbidimetric immunoassay to the cleared ELISA method, resulting in an r-value and slope. However, the sample size for this comparison is not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated for any of the analytical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an analytical performance study for an in vitro diagnostic test measuring a biochemical analyte (Lp-PLA2). There is no "ground truth" established by human experts in the way it would be for imaging diagnostics or clinical judgment. The ground truth for analytical accuracy is determined by established laboratory methods, standard curves, and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
N/A. As stated above, this is an analytical performance study. Adjudication by experts is not applicable here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is an in vitro diagnostic (IVD) assay, not an AI-powered diagnostic system involving human readers. Therefore, an MRMC comparative effectiveness study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone analytical performance study was done. The precision, sensitivity, linearity, and interference studies demonstrate the performance of the device itself (the assay kit) without human interpretation steps beyond standard laboratory procedures for running an automated clinical chemistry analyzer. The method comparison study also evaluates the standalone performance of the new turbidimetric assay against the predicate ELISA assay.
7. The type of ground truth used
The ground truth for the analytical studies is based on:
- Reference standards: Calibrators with known concentrations of recombinant Lp-PLA2 are used to establish standard curves.
- Comparison to a legally marketed predicate device: For method comparison, the results obtained from the new device are compared to results obtained from the previously cleared PLAC® Test (ELISA method) (K062234), which serves as the reference or "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set
N/A. This is a conventional immunoassay kit, not a machine learning or AI-based device that requires a "training set" in the context of algorithm development. The "training set" concept is typically relevant for AI models.
9. How the ground truth for the training set was established
N/A. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context. The "ground truth" for developing the assay itself would be based on biochemical characterization of the analyte (Lp-PLA2), purified recombinant Lp-PLA2, and monoclonal antibodies, as mentioned in the "Characterization of Rare Reagents" section.
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