Bd Integrated Diagnostic Solutions/Becton, · Class II · Cleared Apr 22, 2025
| K-number | K243343 |
| Device name | BD CTGCTV2 |
| Applicant | Bd Integrated Diagnostic Solutions/Becton, |
| Product code | QEP |
| Device class | Class II |
| Decision date | Apr 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3393 |
The BD CTGCTV2 is a molecular diagnostic assay that uses automated DNA extraction and real-time PCR to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA. It is indicated for qualitative detection in urogenital specimens (vaginal swabs, urine) and extragenital specimens (rectal and oropharyngeal swabs for CT and GC only) to aid in diagnosing sexually transmitted infections in asymptomatic and symptomatic individuals. The assay runs on the BD COR™ System.
The subject device adds extragenital specimen claims (rectal and oropharyngeal swabs) for CT and GC detection compared to the predicate, which only supported urogenital and endocervical specimens. Both use the same PCR-based technology, magnetic bead extraction, TaqMan fluorescent probe detection on the BD COR™ System, and identical assay controls and target dyes. The on-board lysis times differ for extragenital samples (10 minutes instead of the standard 30 minutes for urogenital).
ISO 13485 (Quality Management), ISO 14971 (Risk Management), ISO 14155 (Clinical Investigation), ISO 20417 (Manufacturer Information), IEC 62304 (Software Life Cycle), IEC 62366-1 (Usability Engineering), CLSI MM03-ED3:2015 (Molecular Diagnostic Methods), CLSI MM13-ED2:2020 (Specimen Preparation), CLSI EP05-A3:2019 (Precision Evaluation), and CLSI EP25-A:2009 (Reagent Stability).
The device is substantially equivalent because it uses identical detection technology (real-time PCR with same probes, dyes, and optical channels), the same specimen collection/transport methodology, and the same automated extraction and amplification process as the predicate. The addition of extragenital specimens does not change the fundamental technology; analytical studies demonstrate equivalent sensitivity (97.7–100% for CT, 92.8–95.8% for GC) and specificity (99.4–99.8%) on rectal and oropharyngeal matrices through comparison to a composite comparator algorithm. Cross-reactivity, microbial interference, and interfering substances testing confirm the assay maintains analytical performance in the expanded specimen matrix.
View the full FDA submission: accessdata.fda.gov