(30 days)
The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
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The provided text is a 510(k) premarket notification letter from the FDA to KMI Diagnostics, Inc. regarding their IBL DHEA-S ELISA Test Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about:
- Acceptance criteria for device performance.
- The study design or results that prove the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for the training set.
The document is purely a regulatory letter stating that the device is cleared for marketing based on substantial equivalence, not a summary of a performance study.
§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(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 § 862.9.