FDA BRIEF: Week of Oct 31, 2016

BD MAX Vaginal Panel

BD Diagnostics, USA, Canada

INDICATION FOR USE: Automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from Bacterial vaginosis markers, Candida spp.

INTENDED USE: The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

REG PATHWAY: De Novo Request

• Regulation Number: 21 CFR 866.3975
• Regulation Name: Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis
• Regulatory Classification: Class II
• Product Code: PQA, OUY, OOI, NSU

IDENTIFIED RISKS AND MITIGATION:

• Incorrect identification or lack of identification of a pathogenic microorganism by the device can lead to improper patient management: General controls and special controls
• Failure to correctly interpret test results: General controls and special controls
• Special Controls:
  • Premarket notification submissions with detailed device description
  • Premarket notification submissions with performance characteristics
  • Premarket notification submissions of prospective clinical study
  • Premarket notification submissions of device software
  • Labeling requirements

ORDER