(53 days)
The Elecsys Insulin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of recombinant human insulin in bovine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is a 510(k) summary for the Elecsys® Insulin CalCheck 5. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval for a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample size for test sets with ground truth, MRMC studies, standalone algorithm performance) is not applicable to this type of device and submission.
Here's a breakdown of why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance. For a quality control material, acceptance criteria would typically relate to its manufacturing consistency, stability, and its ability to challenge the assay within expected ranges.
- Reported Device Performance: The primary "performance" studied and reported here is related to value assignment and stability. The document states: "The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability." However, specific numerical results or acceptance ranges for these evaluations are not detailed in the provided 510(k) summary. The conclusion simply states that the data demonstrates "substantially equivalent" performance to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. As a quality control material, there isn't a "test set" of patient data for diagnostic evaluation. The evaluations would involve laboratory experiments to assess the material itself. The document does not specify the number of lots or experimental runs used for value assignment or stability studies.
- Data Provenance: Not specified, but the manufacturer is Roche Diagnostics (Indianapolis, IN, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant for a quality control material.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set for diagnostic performance is involved.
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 a quality control material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable.
8. The sample size for the training set:
- Not Applicable. This is not an algorithm or AI device that requires "training data."
9. How the ground truth for the training set was established:
- Not Applicable.
In summary, for K101075 (Elecsys® Insulin CalCheck 5):
The submission is for a quality control material used for calibration verification and assay range verification. The study focused on demonstrating "substantial equivalence" of its "value assignment and Performance Characteristics stability" to a previously cleared predicate device (Elecsys HCG+β CalCheck 5). The detailed technical data from these evaluations (e.g., specific stability curves, results of value assignment studies) is not included in the provided 510(k) summary, only the general conclusion of equivalence.
§ 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.