(19 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/S1).
- 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.
This submission describes the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (modified), which is a progesterone assay. The device is intended for in vitro diagnostic use to quantitatively measure progesterone concentration in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device (VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details a comparison of assay characteristics between the predicate and the new device. It does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on substantial equivalence based on comparable characteristics.
| Device Characteristic | Predicate Device (Current) | New Device (Modified) | Acceptance Criteria/Performance |
|---|---|---|---|
| Number of Calibrators | 3 | 3 | Matches predicate |
| Nominal Calibrator values | 0.0, 4.25, 120 nmol/L | 0.0, 4.25, 120 nmol/L | Matches predicate |
| Physical State of Calibrators | Liquid | Freeze-dried | Change noted; likely evaluated for equivalent performance (details not provided) |
| Reconstitution Volume | Not required | 1 mL | Change noted; likely evaluated for user impact (details not provided) |
| Storage Temperature of Calibrators | 2-8°C | 2-8°C | Matches predicate |
| Calibration range | 0 to 178 nmol/L | 0 to 178 nmol/L | Matches predicate |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay | Matches predicate |
| Tracer | Enzyme labeled | Enzyme labeled | Matches predicate |
| Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System | Matches predicate |
| Sample volume | 25µL | 25µL | Matches predicate |
| Incubation time and temperature | 16 minutes at 37°C with shaking | 16 minutes at 37°C with shaking | Matches predicate |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The submission focuses on comparing the modified device's characteristics to a predicate device, rather than providing detailed clinical study results with a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic device for quantitative measurement, and the ground truth would typically be established by established reference methods or primary analytical measurements, not by expert interpretation in the same way imaging or diagnostic algorithms are validated. The document does not mention the use of experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment is based on analytical performance and comparison to a predicate, not on subjective interpretations requiring adjudication.
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
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone immunoassay system. The document implies that the performance of the VITROS Progesterone assay (modified) was evaluated on its own analytical capabilities to demonstrate substantial equivalence to the predicate. There is no mention of human interaction beyond the operation of the instrument.
7. The Type of Ground Truth Used
The ground truth for this type of in vitro diagnostic device would typically be established through highly accurate and precise analytical reference methods, or by comparing agreement with the predicate device's established performance, rather than pathology, outcomes data, or expert consensus in an observational or interpretive sense. The document states that "the information presented in the pre-market notification demonstrates that the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This implies that the 'ground truth' or benchmark for performance comparison is the predicate device's established performance using recognized analytical methods.
8. The Sample Size for the Training Set
The document does not provide details on a "training set" in the context of machine learning. This device is an immunoassay, not an AI/ML-based algorithm that typically requires a training set. The development of such assays involves analytical validation, linearity studies, precision, accuracy, and interference studies, but these do not fall under the conventional definition of a "training set" for AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not utilize a "training set" in the AI/ML sense. The "ground truth" for developing and validating immunoassay performance would be derived from rigorous analytical testing using known concentrations of analytes, reference materials, and comparison with established methods.
§ 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.