§ 866.3376 Device to detect and identify fungal nucleic acids directly in respiratory specimens.

(a) Identification. A device to detect and identify fungal nucleic acids directly in respiratory specimens is an in vitro diagnostic device intended for the detection and identification of fungal pathogens in respiratory specimens collected from patients with signs or symptoms and suspicion of fungal infection. The device is intended to aid in the diagnosis of fungal disease in conjunction with clinical signs and symptoms and other laboratory findings.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The intended use must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) and testing location(s) for which the device is intended.

(2) The labeling required under 21 CFR 809.10(b) must include:

(i) A detailed device description, including the parts that make up the device, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology including all pre-analytical methods for processing of specimens.

(ii) Performance characteristics from analytical studies, including analytical sensitivity (Limit of Detection), inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, and specimen stability.

(iii) A statement that the device is intended to be used in conjunction with clinical history, signs and symptoms and the results of other diagnostic tests.

(iv) A detailed explanation of the interpretation of test results and acceptance criteria for any quality control testing.

(v) A limiting statement that negative results do not preclude the possibility of infection, and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

(3) Design verification and validation activities must include:

(i) Performance characteristics from clinical studies that include prospective (sequential) samples and, if appropriate, additional characterized samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from comparator methods. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan), clinical study report, and results of all statistical analyses.

(ii) A detailed device description of the following:

(A) Overall device design including all parts that make up the device and all control elements incorporated into the testing procedure.

(B) Thorough description of the methodology including, primer/probe sequences, primer/probe design and rationale for target sequence selection.

(C) Computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result, as applicable.

(iii) A detailed documentation for device software, including, software applications and hardware-based devices that incorporate software.

[90 FR 24968, June 13, 2025]