(30 days)
VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in 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 CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA 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) pre-market notification (K962919). Common reagents used by the VITROS System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which 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) summary for the VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than novel performance metrics against acceptance criteria in a clinical study.
Therefore, many of the requested categories for a typical medical device performance study, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable in the context of this 510(k) submission.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the traditional sense, as it aims to show substantial equivalence. Instead, the performance is demonstrated by comparing the characteristics of the new formulation device to the predicate device. The conclusion of the study is that the performance is "substantially equivalent."
| Characteristic | Predicate Device (Current) | New Device (Modified) |
|---|---|---|
| Number of Calibrators | 3 | 2 |
| Nominal Calibrator values | 0, 5 and 250 ng/mL | 3 & 250 ng/mL |
| Calibration range | 0 to 400 ng/mL | 0 to 400 ng/mL |
| Sample type | Serum and plasma (EDTA or heparin) | Serum and plasma (EDTA or heparin) |
| Antibody | Mouse monoclonal anti-CEA antibody in biotinylated antibody reagent | Mouse monoclonal anti-CEA antibody in biotinylated antibody reagent |
| Base Matrix: Calibrators and Range Verifiers | Liquid BSA | New Born Calf Serum |
| Preservative: Calibrators and Range Verifiers | Proclin | Kathon |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System |
| Sample volume | 20μL | 20μL |
| Incubation time and temperature | 30 minutes at 37°C | 30 minutes at 37°C |
| Acceptance Criteria / Conclusion | N/A | Substantially Equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range."
- Sample Size: Not specified. The number of "human samples" used is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This is an IVD device measuring an analyte concentration. Ground truth would typically be established by reference methods or clinical outcomes, not expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
- Not Applicable: Not relevant for an IVD assay measuring analyte concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
- Not Applicable: This is an IVD assay, not an imaging or diagnostic device requiring human reader interpretation in the context of MRMC studies.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Done (implicitly): The device (VITROS CEA assay) is the standalone "algorithm" or system that quantitatively measures CEA. Its performance is compared to the predicate device. The performance data presented (e.g., precision, accuracy, linearity—though not detailed in this summary) are inherently "standalone" in the context of an IVD.
7. The Type of Ground Truth Used
- The summary indicates that "equivalent performance was demonstrated... testing human samples near the low end of the assay range." For an IVD, the "ground truth" would typically be established through:
- Reference methods: Comparing results to a recognized gold standard method for CEA measurement.
- Clinical correlation: Showing that the measured CEA levels correlate with clinical status or outcomes as expected, similar to the predicate device.
- Known concentrations: Using samples with accurately known CEA concentrations (e.g., controls, spiked samples).
The summary does not explicitly detail the type of ground truth, but implies comparison against the predicate device's established performance, and potentially reference methods for accuracy.
8. The Sample Size for the Training Set
- Not Applicable: This is a traditional immunoassay, not a machine learning or AI-based device requiring a separate "training set" in the computational sense. The "training" of the device is through its manufacturing and calibration processes.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: See point 8.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.