(46 days)
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine.
The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medical purposes for use in an albumin test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
This document is a 510(k) premarket notification decision letter from the FDA for the Microalbumin Multi-Calibrator Set, Cat. No. SE-252. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance as one would typically find for a diagnostic test or an AI/ML powered device.
Instead, this document is a regulatory approval for a calibrator set, which is a reference material used to establish points of reference in an albumin test system. The FDA's review here focuses on whether the device is substantially equivalent to legally marketed predicate devices, not on the performance of the device in a clinical study against specific acceptance criteria like accuracy, sensitivity, or specificity.
Therefore, most of the requested information (points 1-9) about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not applicable or available in this document.
However, I can extract the following relevant information:
- Device Name: Microalbumin Multi-Calibrator Set, Cat. No. SE-252
- Intended Use: For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine.
- Regulatory Classification: Class II
- Product Code: JIX
- Regulation Number: 21 CFR 862.1150 (Calibrator)
To provide an answer to your specific questions, based on the provided text:
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A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or reported device performance in terms of clinical accuracy or similar metrics. The FDA's decision is based on substantial equivalence to a predicate calibrator, implying that the calibrator performs as expected for its intended use rather than measuring its performance against a specific disease outcome.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or available in this document. Substantial equivalence for a calibrator typically involves demonstrating the calibrator's values and stability, not performance on a clinical test set.
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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 or available in this document. Ground truth as typically defined for diagnostic device performance studies is not relevant for a calibrator set's 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or available in this document.
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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 device is a calibrator, not an AI-powered diagnostic system or a device that impacts human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a calibrator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, the "ground truth" would relate to the assigned values of the calibrator materials themselves, established through precise analytical methods, rather than clinical outcome or expert consensus. The document does not specify how these values were established, only that it's a calibrator for an in vitro diagnostic test.
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The sample size for the training set: Not applicable. Calibrators do not typically have "training sets" in the context of machine learning or complex diagnostic algorithms.
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How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory approval for a calibrator, not a performance study for a diagnostic device. The FDA's determination is based on the device being substantially equivalent to existing predicate calibrators, meaning it provides similar performance characteristics for its intended purpose within a larger diagnostic system.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.