BD MAX CTGCTV2, BD MAX System
by Becton, Dickinson and Company
510(k) K182692
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182692 | Date8 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OUY
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3860
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD MAX CTGCTV2 Assay is a nucleic acid amplification test system for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA. Classified as a molecular diagnostic device, it automates nucleic acid extraction and amplification in a single platform, enabling high-throughput testing for sexually transmitted infections (STIs).
This in vitro diagnostic device is intended for laboratory use only and is supplied as a reagent kit for the BD MAX System. It is not sterile for direct patient use and requires processing in a clinical microbiology setting. The assay is cleared by the FDA under 510(k) (K182692) and falls under regulatory category 866.3860. No MRI safety or reusable components are specified; storage and handling follow standard molecular assay protocols.
From the manufacturer
Overview The BD MAX™ system offers you an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays. Flexibility and standardization allow you to address the breadth of your testing needs.
Van Der Pol B, Torres-Chavolla E, Kodsi S, et al. Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What sexually transmitted infections (STIs) can the BD MAX CTGCTV2 Assay detect, and how does it work?
The BD MAX CTGCTV2 Assay is designed to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis through nucleic acid amplification. It automates both DNA extraction and amplification in a single platform, making it ideal for high-throughput testing in clinical microbiology labs. The assay identifies these pathogens by amplifying their DNA for qualitative detection.
Is the BD MAX CTGCTV2 Assay intended for direct patient use, or does it require laboratory processing?
The BD MAX CTGCTV2 Assay is not sterile for direct patient use and is explicitly intended for laboratory processing only. It is supplied as a reagent kit for the BD MAX System, which requires handling in a clinical microbiology setting to perform nucleic acid extraction and amplification.
How is the BD MAX CTGCTV2 Assay supplied, and what type of device does it integrate with?
The BD MAX CTGCTV2 Assay is supplied as a reagent kit designed specifically for use with the BD MAX System, an automated molecular diagnostic platform. It is not a standalone device but rather a consumable component that integrates with the BD MAX’s workflow for nucleic acid testing.
Are there any reusable components in the BD MAX CTGCTV2 Assay, or is it entirely single-use?
The device data does not specify reusable components for the BD MAX CTGCTV2 Assay. As a molecular diagnostic reagent kit, it is designed for single-use within the BD MAX System, adhering to standard molecular assay protocols for sterility and handling.
What regulatory category does the BD MAX CTGCTV2 Assay fall under, and how was its FDA clearance determined?
The BD MAX CTGCTV2 Assay falls under FDA regulatory category 866.3860 and was cleared via a 510(k) submission (K182692). The clearance was determined through a Traditional 510(k) process, with the device deemed Substantially Equivalent to a predicate, as reviewed by the Immunology (IM) Advisory Committee.