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510(k) Data Aggregation
K Number
K023677Device Name
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
Manufacturer
Date Cleared
2003-01-29
(89 days)
Regulation Number
866.2660Why did this record match?
Product Code :
LIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semi-quantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMA™-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.
Device Description
The OMA™-BV uses "electronic nose" technology for the detection of volatile compounds released from microorganisms in human specimens. The principle is based on the release of volatile compounds from bacteria into the headspace [the volume above the High Vaginal Swab (HVS) samples] of clinical samples. The volatile compounds are detected by an array of gas sensors based on patented conducting polymer technology.
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