System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
The Nucleic Acid-Based System for Mycobacterium Tuberculosis Complex with Resistance Markers, Direct Specimen is a microbiology in vitro diagnostic device intended for use with specimens from patients with clinical suspicion of tuberculosis (TB), providing simultaneous detection of Mycobacterium tuberculosis complex and key antimicrobial resistance markers directly from clinical specimens without culture. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3373, requiring 510(k) premarket notification. Rapid resistance detection is essential for guiding appropriate anti-TB therapy. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEU
- Device Class
- FDA class 2
- Regulation Number
- 866.3373
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.