VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)— 510(k) K123197
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K123197 for VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF), Substantially Equivalent on 2012-12-05. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
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More clearances from Nanosphere, Inc.
view all- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
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Recalls naming K123197
K-number listed on FDA's recall record- Z-2024-2023 — VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Z-2010-2021 — Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- Z-2168-2014 — Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
- Z-2682-2014 — The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123197.
Data sourced from openFDA. This site is unofficial and independent of the FDA.