Amplicor Mycobacterium Tuberculosis Test
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST FDA PMA
- Generic Name
- System, nucleic acid amplification, mycobacterium tuberculosis complex FDA PMA
Identifiers
- PMA Number
- P940040 FDA PMA
- FDA Product Code
- MWA FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3372 FDA PMA
- Regulation Number
- 866.3372 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Amplicor Mycobacterium Tuberculosis Test is a target amplified in vitro diagnostic device classified as a nucleic acid amplification system. It is designed for the qualitative detection of Mycobacterium tuberculosis complex DNA in concentrated sediments derived from clinical specimens, including sputum (induced or expectorated), bronchial samples such as bronchoalveolar lavages or aspirates, or tracheal aspirates.
This test is intended for laboratory use only and requires preparation of concentrated sediments from specified specimens. Supplied as a single-use diagnostic kit, it operates under non-sterile conditions prior to specimen processing. The device is regulated under FDA Premarket Approval (PMA) and falls under Class II medical device classification (MWA product code) for microbiology applications, with no MRI safety considerations.
Frequently asked questions
What types of clinical specimens can be tested using the Amplicor Mycobacterium Tuberculosis Test, and how are they prepared?
The Amplicor Mycobacterium Tuberculosis Test is designed to detect *Mycobacterium tuberculosis* complex DNA in concentrated sediments derived from specific clinical specimens, including sputum (induced or expectorated), bronchial samples such as bronchoalveolar lavages or aspirates, and tracheal aspirates. The test requires that these specimens be processed to create concentrated sediments before testing, as the device itself does not perform specimen concentration.
Is the Amplicor Mycobacterium Tuberculosis Test intended for direct use on unprocessed specimens, or does it require laboratory preparation?
The test is not intended for direct use on unprocessed specimens. It requires the preparation of concentrated sediments from the specified clinical specimens (e.g., sputum or bronchial samples) before testing can proceed. This step is necessary because the device relies on concentrated DNA targets for detection.
How is the Amplicor Mycobacterium Tuberculosis Test supplied, and is it reusable?
The Amplicor Mycobacterium Tuberculosis Test is supplied as a single-use diagnostic kit, meaning each kit is designed for one use only. It is not intended for reuse, and the manufacturer does not provide information suggesting reprocessing or sterilization for repeated use.
What regulatory pathway does the Amplicor Mycobacterium Tuberculosis Test follow, and what does this mean for its use in clinical settings?
The test follows the FDA Premarket Approval (PMA) pathway, which is a rigorous regulatory route for high-risk medical devices. This approval indicates that the device has been thoroughly evaluated for safety and effectiveness in detecting *Mycobacterium tuberculosis* complex DNA in concentrated sediments from specified specimens. Clinicians and laboratories should confirm compliance with FDA guidelines and institutional protocols when using this test.
Does the Amplicor Mycobacterium Tuberculosis Test require sterile conditions during its use, or is non-sterile handling acceptable?
The test operates under non-sterile conditions prior to specimen processing, meaning that while the initial handling of the kit does not require sterile techniques, the clinical specimens themselves must be processed to create concentrated sediments. Sterility considerations apply to the specimen preparation steps, not the test kit itself, as outlined in the manufacturer’s instructions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P940040 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P940040 24 fields · synced Sep 18, 2026