(85 days)
The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
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The provided text is a regulatory clearance letter from the FDA for a medical device, specifically the "IBL Testosterone Luminescence Immunoassay." It primarily focuses on the device's classification and substantial equivalence to existing devices.
Crucially, this document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device's performance was compared to a previously cleared device, not necessarily against a set of predefined acceptance criteria in the manner one might expect for a novel or high-risk device requiring detailed clinical trials.
To answer your questions, I would need access to the actual 510(k) premarket notification dossier submitted by IBL-Hamburg, GmbH to the FDA, which would contain the performance data and study details supporting their claim of substantial equivalence.
Therefore, I cannot provide the requested table or information based solely on the text provided.
§ 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.