Bd Max Ct/Gc/Tv, Bd Max Instrument
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151589 FDA 510(k)
- FDA Product Code
- OUY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3860 FDA 510(k)
- Regulation Number
- 866.3860 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD MAX CT/GC/TV Assay is a Trichomonas Vaginalis Nucleic Acid Amplification Test System, designed for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in urogenital specimens. It employs automated DNA extraction followed by real-time PCR to identify these pathogens in clinical samples, supporting diagnostic workflows in immunology and infectious disease testing.
This system is supplied as a fully automated platform, the BD MAX Instrument, which integrates sample processing, nucleic acid extraction, and PCR amplification in a closed, single-use workflow. The device is classified as Class II under FDA regulations and operates under FDA 510(k) clearance (K151589). Specimens are processed in a sterile, disposable cartridge system, ensuring no risk of cross-contamination, and the instrument is intended for use in clinical laboratories with appropriate molecular diagnostics infrastructure.
Frequently asked questions
What pathogens does the BD MAX CT/GC/TV Assay detect, and how does it work?
The BD MAX CT/GC/TV Assay is designed to detect *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Trichomonas vaginalis* DNA in urogenital specimens. It uses automated DNA extraction followed by real-time PCR (polymerase chain reaction) to amplify and identify the genetic material of these pathogens in clinical samples, enabling rapid and accurate diagnostic results for sexually transmitted infections.
Is the BD MAX Instrument single-use or reusable, and how is it supplied?
The BD MAX Instrument is a fully automated platform that operates with a closed, single-use cartridge system for specimen processing, nucleic acid extraction, and PCR amplification. This design eliminates cross-contamination risks and ensures each test is performed in a sterile, disposable cartridge, making the instrument itself reusable for multiple testing sessions while the consumables are single-use.
What type of clinical laboratories can use the BD MAX CT/GC/TV Assay, and what infrastructure is required?
The BD MAX CT/GC/TV Assay is intended for use in clinical laboratories equipped with molecular diagnostics infrastructure. It is designed for immunology and infectious disease testing workflows, requiring facilities capable of handling automated nucleic acid amplification systems like the BD MAX Instrument. The system integrates sample processing, extraction, and amplification, making it suitable for laboratories with the necessary expertise in molecular diagnostics.
How does the sterility of the BD MAX CT/GC/TV Assay ensure safety in testing?
The BD MAX CT/GC/TV Assay ensures sterility through its disposable cartridge system, which is sealed and single-use. This design prevents cross-contamination between samples and maintains a sterile environment throughout the automated workflow, including DNA extraction and PCR amplification, thereby minimizing infection risks and ensuring reliable test results.
What regulatory pathway was followed for the BD MAX CT/GC/TV Assay, and what does this mean for its use?
The BD MAX CT/GC/TV Assay was cleared through the FDA’s 510(k) pathway, specifically under the Traditional route, and is classified as a Class II device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in detecting *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Trichomonas vaginalis* in urogenital specimens.
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. Sources consulted: Bd Max™ Ct/Gc/Tv - 442970 | Bd, BD (company) - Wikipedia, BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589) — FDA 510 (k) | Innolitics, Becton Dickinson – Wikipedia, BD MAX - Sumedical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151589 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K151589 24 fields · synced Sep 18, 2026