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510(k) Data Aggregation
(21 days)
VIDAS PROESTERONE (PRG) (30 409)
The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantit determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for us an aid in the diagnosis and treatment of disorders of the overies and placenta.
The VIDAS Progesterone (PRG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated VIDAS instrument. All assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPR is coated with mouse anti-progesterone antibodies. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing a progesterone derivative conjugated with alkaline phosphatase. Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbellifory! phosphate, is cycled through the SPR and flouresences. The intensity of fluorescence is measured by the optical scanner in the instrument; it is inversely proportional to the progesterone concentration present in the sample.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VIDAS Progesterone (PRG) Assay:
Acceptance Criteria and Device Performance for VIDAS Progesterone (PRG) Assay
Based on the provided 510(k) summary, the acceptance criteria are implicitly derived from the non-clinical and clinical study summaries. The device's reported performance is directly stated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Specificity/Cross-Reactivity | Minimal to no cross-reactivity with other hormones except specified progesterone metabolites. | No cross-reactivity with testosterone, corticosterone, 20a hydroxy-progesterone, 60 hydroxyprogesterone, 16a hydroxyprogesterone, Estrone, Estriol, Estradiol. Cross-reactivity exists with 5a and 5B dilhydroxyprogesterone. Minimal cross-reactivity with 17a hydroxyprogesterone and deoxycorticosterone, but deemed unlikely to cause false elevation due to low normal concentrations. |
| Interfering Substances | No significant interference from common sample collection components or endogenous substances. | No interference with dry glass tubes with separating gel, lithium heparin, EDTA. No interference with hemoglobin, lipids, or bilirubin at tested concentrations. |
| Precision/Reproducibility | Acceptable levels of intra-assay precision and inter-assay/inter-instrument reproducibility. | Intra-assay precision: CV ranging from 14.3% (0.46 ng/ml) to 3.8% (45.1 ng/ml). |
| Inter-assay reproducibility (8 weeks): CV ranging from 24.3% (0.4 ng/ml) to 3.1% (45 ng/ml). | ||
| Inter-assay, inter-instrument reproducibility: CV not exceeding 5.4% for five different serum samples across eight assays on different instruments. | ||
| Correlation with Predicate Device | Strong positive correlation with the predicate device (DPC Coat-A-Count Progesterone assay). | Correlation coefficient of 0.985 with the DPC Coat-A-Count Progesterone assay. Line equation: y = 1.0193x + -0.453. |
| Sensitivity (Limit of Detection) | A defined and acceptable limit of detection for progesterone. | Limit of detection determined to be 0.1 ng/ml of progesterone with a 95% confidence interval. |
| Calibration Stability | Master curve validity ensured by the calibrator over the kit's shelf life. | Body of data supports the use of a single calibrator for this purpose, ensuring master curve validity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the clinical test set used for correlation, sensitivity, or calibration studies.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of this diagnostic assay. For assays like the VIDAS Progesterone test, the "ground truth" for the test set is typically established by comparative analysis with a well-established predicate device or reference method, not by expert interpretation of images or clinical data. The DPC Coat-A-Count Progesterone assay served as the predicate device against which the VIDAS assay was compared.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1, 3+1) is not applicable here. Adjudication methods are typically used in clinical trials or studies involving human readers and subjective interpretations (e.g., radiology studies) to resolve discrepancies among experts. For quantitative assays like this, the comparison is directly between the result of the new device and the result of the predicate/reference method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of human readers, sometimes with and without AI assistance, typically in medical imaging. This document describes a diagnostic assay, not an imaging device that would involve human readers interpreting AI outputs.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The performance detailed in this summary is effectively standalone performance. The VIDAS Progesterone assay is an automated Enzyme-Linked Fluorescent Immunoassay (ELFA) performed entirely by the VIDAS instrument. While a human initiates the test and interprets the numerical result, the "performance" of the device itself (accuracy, precision, sensitivity, etc.) is measured based on the automated output. There isn't a "human-in-the-loop" component that actively modifies the assay's output during the measurement process.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical validation was comparison with a legally marketed predicate device, specifically the DPC Coat-A-Count Progesterone assay. This serves as the reference standard against which the new device's performance (correlation) is measured. The limit of detection and precision studies also use controlled samples with known progesterone concentrations.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a biochemical assay, not a software algorithm that undergoes a training phase with a distinct dataset. The development and optimization of such assays involve method development and validation, but not typically a "training set" as defined in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
As discussed in point 8, there is no explicit "training set" mentioned or implied for this biochemical assay in the context of AI/ML. The "ground truth" for the development and optimization of the assay's reagents and methodology would have been established through standard chemical and biological assay development practices, using reference materials and established analytical techniques.
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