(15 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of carcinoembryonic antigen (CEA).
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, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products RangeVerifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to perform a VITROS assay). 2. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS ECi System in each assay. The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided document is a 510(k) summary for the VITROS Immunodiagnostic Products CEA Range Verifiers. This device is a range verifier used to check the calibration of an immunoassay system (VITROS Immunodiagnostic System) for measuring carcinoembryonic antigen (CEA).
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific numerical acceptance criteria or present performance data for the VITROS Immunodiagnostic Products CEA Range Verifiers. Instead, it relies on a demonstration of "substantial equivalence" to a predicate device, the VITROS Immunodiagnostic Products FSH Range Verifiers.
The "performance" is implicitly demonstrated through the similarities in characteristics and intended use, and the conclusion that these similarities are sufficient to ensure safety and effectiveness.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Implied from substantial equivalence) |
|---|---|---|
| Intended Use | Verifies calibration range for CEA measurement | Similar to predicate device, but for CEA instead of FSH. |
| Matrix | Buffered bovine serum albumin spiked with human origin analyte | Similar to predicate device, which uses freeze-dried human plasma spiked with human pituitary FSH. The difference in matrix and analyte type is acknowledged but deemed acceptable for equivalence. |
| Range Verifier Levels | Low and high | Matches predicate device. |
| Safety & Effectiveness | Device is safe and effective for its intended use | Data presented provide "reasonable assurance" of safety and effectiveness, based on comparison to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not report any specific sample sizes for a "test set" or provide details on the data provenance (e.g., country of origin, retrospective/prospective). The submission primarily relies on comparing the characteristics of the new device to a predicate device rather than presenting new performance data from testing a specific sample set of the CEA Range Verifiers.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable or not provided in the document. Since no specific "test set" of patient samples is described, there's no mention of experts establishing ground truth for such a set. The ground truth for the device itself (its intended function) is implicitly based on the established clinical utility of range verifiers in general and comparison to the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided in the document, as no specific test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable or not provided. An MRMC study is typically performed for diagnostic devices that involve human interpretation (e.g., radiologists reading images using AI assistance). This device is a laboratory control/range verifier, not a diagnostic imaging AI, so such a study would not be relevant.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable or not provided. This device is a physical reagent used in conjunction with an instrument (VITROS ECi Immunodiagnostic System). It does not involve a standalone algorithm in the sense of AI or image analysis. Its "performance" is in its ability to reliably verify the calibration range within the complete assay system.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating the substantial equivalence of the CEA Range Verifiers is primarily comparison to the established characteristics and performance of the predicate device (VITROS FSH Range Verifiers). This is not ground truth in the sense of pathology, patient outcomes, or expert consensus on clinical cases, but rather a regulatory "ground truth" derived from an already approved, similar product.
8. Sample Size for the Training Set:
This information is not applicable or not provided. This device is a chemical reagent, not a machine learning model, so there is no "training set."
9. How Ground Truth for the Training Set Was Established:
This information is not applicable or not provided, as there is no training set for this type of device.
In summary:
This 510(k) submission for the VITROS Immunodiagnostic Products CEA Range Verifiers primarily demonstrates substantial equivalence to a predicate device (VITROS FSH Range Verifiers) by comparing their intended uses and device characteristics. It does not present new performance data from clinical or laboratory studies using a specific test set, nor does it involve AI algorithms, human readers, or the concept of training for a machine learning model. The acceptance criteria are implicitly met by showing enough similarity to an already approved device to conclude equivalent safety and effectiveness.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.