(84 days)
Fujirebio Diagnostics Vitamin D Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D.
This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Three levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.
This document is a 510(k) Premarket Notification for a Vitamin D Control product, not an AI-powered device. Therefore, many of the requested criteria regarding AI technology, such as sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable.
The document describes the Fujirebio Diagnostics Vitamin D Control, which is an assayed control serum intended to monitor the precision of laboratory testing procedures for the analysis of Vitamin D. This is a quality control material, not a diagnostic device that performs analysis or requires AI.
Acceptance Criteria and Device Performance:
The document focuses on establishing substantial equivalence to a predicate device (Bio-Rad Liquichek™ Specialty Immunoassay Control - 25-OH Vitamin D component, K043108). This means the "acceptance criteria" are essentially the demonstration that the proposed device performs comparably to the legally marketed predicate device for its intended use, which is monitoring the precision of laboratory testing for Vitamin D.
The document does not provide specific quantitative "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, or AUC) as it is a control material, not a diagnostic test with a clinical outcome. Instead, it highlights similarities in intended use, device type, classification, regulatory information, analyte, matrix, and number of levels.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for a control product):
| Acceptance Criterion (Similarity to Predicate) | Reported Device Performance (Proposed Device) |
|---|---|
| Intended Use | Intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of Vitamin D. |
| Device Type | In vitro diagnostic |
| Classification | Class I |
| CFR Section | 862.1660 |
| Product Usage | Clinical and Hospital laboratories |
| Analyte | 25(OH) Vitamin D |
| Matrix | Human Serum, protein (bovine), purified biochemical materials, and chemicals. Proclin 300 and Gentamicin as preservatives. |
| Number of Levels | 3 |
Details Not Applicable to this Device Type (Quality Control Material):
- Sample sized used for the test set and the data provenance: Not applicable. This is a control material, not a diagnostic test evaluated on patient samples. The "studies" involve demonstrating lot-to-lot consistency and stability, and establishing expected ranges across different analyzers. These details are not provided in the 510(k) summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a control material in the same way as for a diagnostic test.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For a control material, "ground truth" would relate to the assigned target values and acceptable ranges which are determined through extensive testing and characterization against reference methods or established internal standards. These specific methods are not detailed in the 510(k) summary.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
In summary, this 510(k) submission is for a quality control product, not an AI or image analysis device. Therefore, the detailed questions related to AI-specific study designs and performance metrics are not relevant to this document. The "study" referenced in the 510(k) process is primarily a demonstration of substantial equivalence to an existing predicate device through comparison of features and intended use.
§ 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.