(36 days)
The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600 ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.
The provided text is a 510(k) summary for the Microgenics Cyclosporine Controls, focusing on demonstrating substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria in the manner typical for AI/ML device evaluations.
Therefore, many of the requested sections below cannot be fulfilled directly from the provided document as it does not contain information on: a test set for performance evaluation against ground truth, expert involvement for ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, training set details, or explicit acceptance criteria in a quantitative sense for device performance.
Instead, the document focuses on comparing the new device's characteristics and intended use to legally marketed predicate devices to establish substantial equivalence.
Here's an attempt to extract and infer information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy, precision, or bias targets) that would typically be evaluated in a study for a novel diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices based on shared characteristics and intended use.
| Acceptance Criteria Category | Specific Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Comparison to Predicates) |
|---|---|---|
| Intended Use | Must be for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine. | Matches the intended use of the CEDIA® Cyclosporine Plus High Range Controls and Lyphochek® Whole Blood Control. |
| Matrix | Processed Human Whole Blood. | Matches the matrix of both predicate devices. |
| Form | Lyophilized. | Matches the form of both predicate devices. |
| Analytes | Cyclosporine. | Matches the primary analyte of both predicate devices (Lyphochek includes additional analytes but the common one is cyclosporine). |
| Reconstituted Vial Claim | 14 days at 2°C to 8°C. | Matches the claim of both predicate devices. |
| Storage | 2°C to 8°C until expiration date. | Matches the storage conditions of both predicate devices. |
| Stability | Until expiration date noted on vial label. | Matches the stability claim of both predicate devices. |
| Manufacturing Methods | Manufactured using methods virtually identical to predicate. | Stated that manufacturing methods are "virtually identical" to CEDIA® predicate. |
| Safety and Effectiveness | Provide reasonable assurance of safety and effectiveness for the stated intended use. | This is the overarching conclusion of the 510(k) based on the substantial equivalence argument, without specific quantitative performance data presented. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes a comparison to predicate devices, not a study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "data" provided is a comparison of product characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of information is pertinent to AI/ML or image-based diagnostic devices where ground truth often requires expert labeling or interpretation. This document describes a quality control material.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process described.
5. 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/ML device and therefore, MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established characteristics and performance of the predicate devices themselves, deemed safe and effective. The new device demonstrates substantial equivalence by matching these characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no training set mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.