§ 866.3988 — Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.

§ 866.3988 Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.

(a) Identification. A device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from human clinical specimens collected from patients with suspected orthopedic infection. The device detects specific nucleic acid sequences for microorganism identification as well as markers for antimicrobial resistance. This device is intended to aid in the diagnosis of orthopedic infections when used in conjunction with other clinical signs and symptoms and other laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

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

(1) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) An intended use that includes a detailed description of targets the device detects and measures, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.

(ii) Limiting statements, when applicable, indicating:

(A) The device is intended to be used in conjunction with clinical history, signs and symptoms, and results of other diagnostic tests, including culture and antimicrobial susceptibility testing;

(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and that the source of a detected resistance marker may be an organism not detected by the assay; and

(C) Antimicrobial resistance can occur via multiple mechanisms. A not detected result for the antimicrobial resistance gene assays does not indicate antimicrobial susceptibility. Culturing and susceptibility testing of isolates is needed to determine antimicrobial susceptibility.

(iii) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens.

(iv) Detailed descriptions of the performance characteristics of the device for all claimed specimen types as shown by the analytical and clinical studies required under paragraphs (b)(3)(iii) and (b)(3)(iv) of this section except specimen stability performance characteristics.

(3) Design verification and validation must include:

(i) A detailed device description, including all device parts, control elements incorporated into the test procedure, reagents required but not provided, the principle of device operation and test methodology, and the computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result).

(ii) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

(iii) Detailed documentation of analytical studies, including those demonstrating Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.

(iv) Detailed documentation and performance results from a clinical study that includes prospective (sequentially collected) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator method that FDA has determined to be appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.

[91 FR 25785, May 12, 2026]