(167 days)
The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in serum and plasma. For In Vitro Diagnostic Use.
Not Found
This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria or specific study results.
The letter confirms that the STC Cotinine Micro-Plate EIA (Serum and Plasma) device is substantially equivalent to legally marketed predicate devices. However, it does not detail the studies performed to demonstrate this equivalence or the performance characteristics required for clearance.
Therefore, I cannot provide the requested information from this document. It lacks details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(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.