21 CFR 866.3372 — System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3372
Identification
Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens are qualitative nucleic acid-based in vitro diagnostic devices intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. These devices do not include devices intended to detect the presence of organism mutations associated with drug resistance. Respiratory specimens may include sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.
Classification Rationale
Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.” For availability of the guideline document, see § 866.1(e).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MWA | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex | 2 | 2 |
Special Controls
MWA — System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of*Mycobacterium tuberculosis* Complex in Respiratory Specimens.” For availability of the guideline document, see § 866.1(e).
eCFR
MWA — System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
The special control for this device is the FDA document entitled “Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.” For availability of the guideline document, see § 866.1(e).
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