(24 days)
VITROS Progesterone Reagent Pack For in vitro diagnostic use only. The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA or heparin).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) submission for a modified VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators. This type of submission demonstrates substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical study with acceptance criteria in the same way a novel device might. Therefore, many of the requested categories are not directly applicable or are addressed by demonstrating equivalence to the predicate.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Progesterone values spanning the assay range." This implies that the 'acceptance criteria' for this submission was demonstrating substantial equivalence in assay characteristics and performance (accuracy, precision, linearity, etc.) to the predicate device.
The study presented focuses on comparing the modified device's assay characteristics to the predicate device. The performance is "reported" through this comparison, asserting clinical equivalence.
Table 1: List of Assay Characteristics: Comparison to Predicate Device (from the document)
| Device Characteristic | Predicate Device VITROS Progesterone assay (Current) | New Device VITROS Progesterone assay (Modified) |
|---|---|---|
| Number of Calibrators | 2 | 3 |
| Nominal Calibrator values | 3.40 and 137 nmol/L | 0.0, 4.25, 120 nmol/L |
| Calibration range | 0 to178 nmol/L | 0 to178 nmol/L |
| Sample type | Serum and plasma (EDTA or heparin). | Serum and plasma (EDTA or heparin). |
| Antibody | Rabbit polyclonal anti-progesterone antibody in biotinylated antibody reagent | Rabbit polyclonal anti-progesterone antibody in biotinylated antibody reagent |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System |
| Sample volume | 25µL | 25µL |
| Incubation time and temperature | 16 minutes at 37°C with shaking | 16 minutes at 37°C with shaking |
The document concludes "the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This is the reported device performance and the key criterion for 510(k) clearance.
Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document only states "patient samples with measured Progesterone values spanning the assay range." It does not specify the exact number of patient samples used in the equivalence study.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified, but typically, for 510(k) in-vitro diagnostic submissions, comparative studies often use banked (retrospective) samples or newly collected (prospective) samples run in parallel. The text does not provide this detail.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. For an in-vitro diagnostic assay that measures a biomarker, the "ground truth" is typically the measured value itself, often derived from a reference method or the predicate device, not expert consensus in the way it would be for image analysis or clinical diagnosis. The study here compares the modified device's measurements to the predicate device's measurements, not to an expert-established ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to studies where multiple readers or experts assess a case and their opinions need to be reconciled, such as in imaging studies. For an in-vitro diagnostic assay, the measurement itself is the output.
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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:
- Not applicable. This is not an AI/imaging device and does not involve human readers interpreting results. It is an in-vitro diagnostic assay.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a standalone in-vitro diagnostic assay. Its performance is evaluated biochemically (how well it measures progesterone), not as an algorithm-only or human-in-the-loop system in the AI sense. The study effectively acts as a standalone performance evaluation compared to the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the measured progesterone values obtained from the predicate device or potentially a recognized reference method, to which the modified device's measurements are compared to demonstrate substantial equivalence.
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The sample size for the training set:
- This concept is typically for machine learning or AI models. For an in-vitro diagnostic assay, there isn't a "training set" in the same sense. The development of the assay's reagents and calibration curves would involve internal validation and optimization, but the document doesn't detail the number of samples used during that specific development phase. The submission focuses on the final product's performance for equivalence.
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How the ground truth for the training set was established:
- As there is no "training set" in the AI sense, this is not applicable. The assay's performance characteristics (e.g., linearity, precision, accuracy) are established through analytical studies using reference materials, spiked samples, and patient samples with known or well-characterized progesterone levels.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.