(17 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).
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 Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Immunodiagnostic Products AFP Range Verifiers are for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP). The matrix of the Range Verifiers is a base matrix of freeze-dried human serum (low) or cord serum AFP in human serum (high). There are low and high Range Verifier levels.
This document describes the VITROS Immunodiagnostic Products AFP Range Verifiers, a device intended for in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary for a range verifier, which is a quality control device. For such devices, acceptance criteria are typically related to their ability to reliably verify the operational range of a primary assay, rather than diagnostic performance metrics like sensitivity or specificity. The summary focuses on demonstrating substantial equivalence to a predicate device based on intended use and physical characteristics. Therefore, explicit "acceptance criteria" and "device performance" in terms of clinical accuracy or statistical measures are not directly presented in the provided text for the range verifier itself.
Instead, the document asserts:
| Characteristic | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|---|
| Intended Use | To be substantially equivalent to the predicate device in its intended use, which is verifying the calibration range of the VITROS Immunodiagnostic System. | "For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP)." This matches the predicate device's intended use with the analyte changed from FSH to AFP. |
| Matrix Type | To have a matrix suitable for its intended use, comparable in principle to the predicate device's matrix. | "A base matrix of freeze-dried human serum (low) or cord serum AFP in human serum (high)." This is described and compared to the predicate's matrix (freeze-dried human plasma spiked with human pituitary FSH). While different, the context implies suitability for the purpose. |
| Range Verifier Levels | To provide at least two distinct levels for verifying the calibration range. | "Low and high." This is identical to the predicate device. |
| Safety & Effectiveness | To provide reasonable assurance of safety and effectiveness for the stated intended use. | "The data presented in the premarket notification provide a reasonable assurance that the VITROS AFP Range Verifiers are safe and effective for the stated intended use." |
| Substantial Equivalence | To demonstrate substantial equivalence to a legally marketed predicate device. | "The VITROS Immunodiagnostic Products AFP Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device)." The conclusion states, "Equivalence was demonstrated by comparing the physical properties and intended uses of these devices..." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not contain information about a test set sample size, data provenance, or specific study data for the AFP Range Verifiers. The submission focuses on substantial equivalence based on a comparison of device characteristics and intended use to a predicate device. There is no mention of a separate performance study with a test set for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document does not describe a performance study involving a test set that requires expert-established ground truth for the VITROS AFP Range Verifiers.
4. Adjudication Method for the Test Set:
This information is not applicable as the document does not describe a performance study involving a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or, at least, is not mentioned in this 510(k) summary. This type of study is typically associated with diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The VITROS AFP Range Verifiers are quality control materials, not diagnostic AI algorithms.
6. Standalone Performance Study:
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described for the VITROS AFP Range Verifiers. The summary's focus is on demonstrating equivalence to an existing predicate device rather than presenting new performance data for this type of quality control product.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in diagnostic algorithm evaluation (e.g., pathology, outcomes data) is not applicable or discussed for this device. The VITROS AFP Range Verifiers are quality control materials. Their "truth" relates to their assigned concentration values and their stability, which would be established through a manufacturing and quality control process, not by comparing to clinical outcomes or pathology.
8. Sample Size for the Training Set:
This information is not applicable. The VITROS AFP Range Verifiers are reagents, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth established in that context.
§ 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.