(24 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of folate in human serum, plasma (heparin) and whole blood.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of vitamin B12 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, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- 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 510(k) pre-market notification (K964310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) summary for "VITROS Immunodiagnostic Products Folate Range Verifiers" and "VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers." This document establishes substantial equivalence to a predicate device, rather than performing a de novo study to establish performance against acceptance criteria. Therefore, most of the requested information about device performance, study details, ground truth, and sample sizes is not applicable or not provided in this type of submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance criteria for a novel device. The "performance" is inferred to be comparable to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (This submission demonstrates substantial equivalence to a predicate device, not de novo performance against acceptance criteria). | Not Applicable (The document asserts equivalence, rather than providing specific performance metrics against pre-defined criteria). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document does not describe a test set or data provenance in the context of validating a new device's performance against clinical data or a ground truth. The equivalence is demonstrated by comparing physical properties and intended uses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not provided. No expert panel was involved in establishing ground truth for a test set, as this was not a de novo study for performance validation.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a range verifier for an immunoassay system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a diagnostic reagent, not an algorithm, so a standalone performance study as described is not relevant.
7. The Type of Ground Truth Used
Not applicable. The concept of "ground truth" as typically used in medical device validation (e.g., pathology, outcomes data) is not relevant here. The "truth" in this context is the established functionality and performance of the predicate device, against which the new device is compared for equivalence.
8. The Sample Size for the Training Set
Not applicable/Not provided. Since this is not a study involving algorithm training, no training set or sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set mentioned, the establishment of its ground truth is also not applicable.
Summary of Equivalence Statement:
The core of the submission lies in demonstrating substantial equivalence to the predicate device, VITROS Immunodiagnostic Products FSH Range Verifiers (K973517). This is achieved by comparing:
- Intended Use: Both devices are used for verifying the calibration range of the VITROS Immunodiagnostic System. The difference is the specific analytes measured (Folate/Vitamin B12 for the new device vs. FSH for the predicate).
- Matrix of Range Verifiers: Both utilize a base matrix of human plasma (liquid or freeze-dried) or buffered matrix spiked with the analyte.
- Range Verifier Levels: Both have low and high levels.
The data presented demonstrate that the physical properties and intended uses of the VITROS Folate and Vitamin B12 Range Verifiers are comparable to the predicate device, leading to the conclusion of substantial equivalence. This implies that the new device is as safe and effective as the predicate.
§ 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.