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510(k) Data Aggregation
K Number
K042357Device Name
IDI-MRSA ASSAY
Manufacturer
INFECTIO DIAGNOSTIC (I.D.I.) INC.
Date Cleared
2004-10-22
(52 days)
Product Code
NQX
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
INFECTIO DIAGNOSTIC (I.D.I.) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler® instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
IDI-MRSA is not intended to diagnose MRSA infections nor to guide or monitor treatment for Concomitant cultures are necessary only to recover organisms for MRSA infections. epidemiological typing or for further susceptibility testing.
Device Description
A nasal specimen is collected and transported to the laboratory using the Copan Venturi Transystem®. For testing, the swab is placed in sample preparation buffer. The specimen is concentrated and lysed. An aliquot of the lysate is added to PCR reagents which contain the MRSA-specific primers used to amplify the genetic target [a sequence near the insertion site of Staphylococcal Cassette Chromosome mec (SCCmec)], if present. The assay also includes an internal control (IC) used to detect PCR inhibitory specimens and to confirm the integrity of assay reagents in negative specimens. Amplified targets are detected with hybridization probes labeled with quenched fluorophores (molecular beacons). The amplification, the detection of fluorescence and the interpretation of signals are done automatically by the Smart Cycler® instrument. The whole processed takes about 60 to 75 minutes, depending on the number of specimens processed. This is in addition to specimen preparation which takes about 15 minutes. If appropriate, culture media can be inoculated during specimen preparation or up to 24 hours after its preparation.
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K Number
K033415Device Name
IDI-MRSA
Manufacturer
INFECTIO DIAGNOSTIC (I.D.I.) INC.
Date Cleared
2004-03-18
(143 days)
Product Code
NQX
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
INFECTIO DIAGNOSTIC (I.D.I.) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler® instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
IDI-MRSA is not intended to diagnose MRSA infections nor to guide or monitor treatment for Concomitant cultures are necessary only to recover organisms for MRSA infections. epidemiological typing or for further susceptibility testing.
Device Description
IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). A nasal specimen is collected and transported to the laboratory using the Copan Venturi Transystem®. For testing, the swab is placed in sample preparation buffer. The specimen is concentrated and lysed. An aliquot of the lysate is added to PCR reagents which contain the MRSA-specific primers used to amplify the genetic target [a sequence near the insertion site of Staphylococcal Cassette Chromosome mec (SCCmec)], if present. The assay also includes an internal control (IC) used to detect PCR inhibitory specimens and to confirm the integrity of an internal of the PC (C is a DNA fragment of 335-bp including a 277-bp assay reagents in hogative optionnel to targets are detected with hybridization probes labeled sequence fluorophores (rnolecular beacons). For the detection of MRSA amplicons, the with quencher beacon contains the fluorophore 5-carboxyfluorescein (amine reactive ester of molocally beader commonly called FAM) at the 5' end and the non-fluorescent quencher carboxy-liderooooin bonneeriy on the opposite end of the oligonucleotide. For the detection moley daboy onlorido (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) ( fluorescein (TET) at the 5' end and the non-fluorescent quencher moiety DABCYL at the 3' end. The test is performed on the Smart Cycler® instrument which monitors simultaneously the fluorescence emitted by each beacon, interprets all data and at the end of the cycling program provides a final result.
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