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510(k) Data Aggregation
(186 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PLAC® Test for Lp-PLA2 Activity:
The document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. There is limited information on clinical acceptance criteria against specific clinical endpoints derived from a prospective study. The "acceptance criteria" presented are primarily for analytical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document provides analytical performance criteria rather than clinical effectiveness criteria. The "Acceptance Criteria" column below is extracted directly from the precision tables or implied by the statements for other analytical metrics.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Total CV) | ≤8% | Lot 1: Kit Control Low (2.6%), Kit Control High (2.2%), Sample 1 (2.0%), Sample 2 (2.0%), Sample 3 (2.4%), Sample 4 (1.5%) Lot 2: Kit Control Low (2.3%), Kit Control High (2.3%), Sample 1 (2.1%), Sample 2 (2.7%), Sample 3 (2.9%), Sample 4 (2.1%) Lot 3 (partial data): Kit Control High (2.3%), Sample 1 (2.2%), Sample 2 (2.2%), Sample 3 (2.4%), Sample 4 (2.1%) All reported total CVs are < 3%. |
| Precision (Within-Run CV) | ≤5% | All reported within-run CVs are between 1.0% and 1.9%. |
| Analytical Sensitivity | LoQ: ≤ 20% CV (at 10 nmol/min/mL) | LoB: 0.40 nmol/min/mL LoD: 0.74 nmol/min/mL LoQ: 10 nmol/min/mL (with allowable CV of 20%) |
| Linearity | Deviation from linearity ≤10% | Slopes: 0.98 to 1.04 Intercepts: -0.4 to -0.03 nmol/min/mL R² values: 0.995 to 0.999 Linearity demonstrated from 10 to 382 nmol/min/mL with deviation from linearity ≤10%. |
| Recovery | Undefined explicit criteria; implied good correlation | Slopes: 0.99 to 1.10 Intercepts: -2.9 to 4.2 nmol/min/mL R² values: 0.997 to 1.000 |
| Endogenous Interferences | 90-110% recovery in measured Lp-PLA2 activity level | All tested substances (Albumin, Conjugated Bilirubin, Unconjugated Bilirubin, Cholesterol, Triglycerides, Hemoglobin) met the 90-110% recovery criterion at specified high concentrations. |
| Exogenous Interferences | "No appreciable interference" | No appreciable interference observed for all listed substances (Acetaminophen, Aspirin, Atorvastatin, Diphenhydramine, Fenofibrate, Lisinopril, Niacin, Tolbutamide, Warfarin, Metformin, Clopidogrel bisulfate, Vitamin C) at tested low and high concentrations. |
| Specimen Stability | (Reference to package insert) | Whole blood: Up to 4 hours at 20-22°C or up to 30 hours at 2-8°C After centrifugation: 24 hours at 20-26°C Up to 2 weeks at 2-8°C Up to 18 months at -20°C Up to 2 years at -70°C Freeze/thaw: Up to 5 times at -70°C or -20°C Transport: on cold packs at 2-8°C |
| Reagent Stability | (Reference to package insert) | Shelf life: 12 months at 2-8°C (demonstrated 13 months real-time) Opened vial: 4 weeks at 2-8°C (reagents); 3 months at 2-8°C (calibrators/controls) (established 16-weeks for opened vials) On-board: 4 weeks at 2-8°C (established 6-weeks) |
| Matrix Comparison | "Comparable to K2 EDTA plasma" | All tested tube types (K3 EDTA plasma without separator gel, K2 EDTA plasma and serum with and without separator gel) were comparable to K2 EDTA plasma tube without separator gel. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: 4 native plasma samples, 2 kit controls (low and high) were tested. Each sample/control was tested with 2 replicates per run, 2 runs per day for 20 days (N=80 results for each sample/control).
- Analytical Sensitivity (LoB, LoD, LoQ): Not specified beyond "performed according to CLSI EP17-A2."
- Linearity: "Several dilution series were prepared from native plasma samples." Specific number not given.
- Recovery: "Seven activity levels" were created, but the number of unique samples is not given.
- Endogenous Interferences: Four plasma samples with varying Lp-PLA2 levels were used. Five replicates were tested for each level.
- Exogenous Substances: Four native plasma samples were used. Each spiked potential interferent was tested in duplicate.
- Matrix Comparison: Five different blood collection tube matrices were compared with an unspecified number of samples (Lp-PLA2 activity values ranged from 56 to 357 nmol/min/mL).
Data Provenance: The document does not explicitly state the country of origin for the samples used in these non-clinical studies. The studies are retrospective in the sense that they are laboratory evaluations of device performance characteristics (analytical validation) using collected samples, rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document, as the studies described are analytical performance evaluations of an in vitro diagnostic (IVD) device. The "ground truth" for these tests refers to the known concentrations or activity levels of the analyte (Lp-PLA2) in the samples, or the expected chemical behavior, established through reference methods or spiking, not through expert clinical image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple readers assess cases and a consensus or tie-breaking mechanism is needed for the ground truth. The studies described here are laboratory analytical performance validations, not involving human readers or case adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or cognitive tasks where AI assistance could improve performance. This device is an in vitro diagnostic (IVD) for laboratory use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The studies described are for a standalone IVD device, meaning the algorithm/assay performance is evaluated inherently without human-in-the-loop performance in the context of the assay's function. The "algorithm" here is the enzyme assay itself and the calculation of Lp-PLA2 activity from absorbance changes.
7. The Type of Ground Truth Used
For the analytical performance studies, the "ground truth" was established based on:
- Known concentrations/activity levels for spiked samples (e.g., recovery studies, linearity using dilution series).
- Reference methods (implied for initial characterization of native plasma samples).
- Expected chemical behavior and measurement principles (e.g., precision for known controls, analytical sensitivity's statistical derivation).
For the broader indication of aiding in predicting CHD risk, the document mentions "clinical evaluation and patient risk assessment" in conjunction with the Lp-PLA2 activity, implying that the output of the device (Lp-PLA2 activity level) contributes to a broader clinical decision-making process, rather than being a direct diagnostic ground truth itself.
8. The Sample Size for the Training Set
This information is not provided. The document describes validation studies demonstrating device performance, not the development or training of an AI algorithm from a dataset. For IVDs, the "training set" doesn't typically apply in the same way it does for machine learning algorithms. The process involves assay development, optimization, and then validation against established analytical performance goals.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable in the context of the document. As explained for point 8, the document is about validating an IVD assay, not training a machine learning model. The ground truth for developing and optimizing such an assay would typically involve highly characterized reference materials and established laboratory methods.
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