Search Results
Found 10 results
510(k) Data Aggregation
K Number
K140619Device Name
MECA XPRESSFISH
Manufacturer
ADVANDX, INC.
Date Cleared
2014-10-10
(213 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay.
The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.
Device Description
The mecA XpressFISH assay is a qualitative fluorescence in situ hybridization (FISH) assay which utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) on smears from blood cultures containing Staphylococcus aureus (SA). After the positive blood culture bottle is confirmed to have SA by Staphylococcus QuickFISH BC, an aliquot of the blood culture is incubated with media containing cefoxitin to induce mecA mRNA expression prior to mecA XpressFISH testing.
The assay consists of mecA mRNA inducing cefoxitin reagents, a fixation reagent, a hybridization reagent, a wash solution concentrate, coverslip mounting media and a microscope slide which has a sample well, and positive and negative control wells. Results are visualized and interpreted using fluorescence microscopy.
Ask a Question
K Number
K133851Device Name
ALERE PBP2A SA/CONS CULTURE COLONY TEST
Manufacturer
ALERE SCARBOROUGH, INC
Date Cleared
2014-09-03
(258 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alere™ PBP2a SA Culture Colony Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus as an aid in identifying methicillin-resistant Staphylococcus aureus (MRSA).
Device Description
The Alere™ PBP2a SA Culture Colony Test is a rapid immunochromatographic membrane assay intended for the detection of penicillin-binding protein 2a (PBP2a) in isolates identifies as Staphylococcus aureus as an aid in identification of MRSA. The test uses highly sensitive recombinant monoclonal antibody fragments (rFabs) to detect the PBP2a protein directly from bacterial isolates. The rFab and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a pink/purple conjugate pad, and an absorption pad to form a test strip.
Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the test strip is placed in the assay tube. Results are read visually at 5 minutes.
Ask a Question
K Number
K121905Device Name
ALERE PBP2A TEST
Manufacturer
ALERE SCARBOROUGH, INC
Date Cleared
2012-07-26
(27 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alere™ PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.
Device Description
The Alere™ PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip. Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.
Ask a Question
K Number
K090301Device Name
BINAXNOW PBP2A TEST, MODEL 890-000
Manufacturer
BINAX, INC.
Date Cleared
2010-04-14
(432 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus.
The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.
Device Description
The BinaxNOW® PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from blood cultures which have been identified as being positive for S. aureus. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device.
Specimens are aliquots from blood cultures which have been identified as positive for Staphylococcus aureus. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.
Ask a Question
K Number
K091766Device Name
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
Manufacturer
BINAX, INC.
Date Cleared
2010-02-24
(252 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.
Device Description
The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip.
Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.
Ask a Question
K Number
K062864Device Name
MASTALEX -MRSA, MODEL RST501
Manufacturer
MAST GROUP LTD.
Date Cleared
2006-10-18
(23 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.
Device Description
Rapid slide latex kit for confirmation of Methicillin-resistant Staphylococcus aureus (MRSA).
The kit tests for the mecA gene coding for methicillin resistance, by detecting its product, PBP2' (penicillin binding protein 2'). Organisms grown on suitable culture medium and believed to be Staphylococcus aureus, are emulsified in an extraction reagent, boiled for a set period of time under alkaline conditions, neutralised and centrifuged. A specified volume of supernatant liquid is mixed with a drop of test latex sensitised with a monoclonal antibody directed against PBP2' and control (unsensitised) latex on a test card. The cards are rotated for a defined length of time and examined for agglutination. A positive reaction observed with the test latex only indicates that the organism contains PBP2' and should be reported as a presumptive methicillin-resistant Staphylococcus aureus (MRSA).
Ask a Question
K Number
K011710Device Name
OXOID PBP2 1 LATEX AGGLUTINATION TEST
Manufacturer
OXOID, LTD.
Date Cleared
2002-04-02
(302 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
Device Description
PBP21 Latex Agglutination Test
Ask a Question
K Number
K011400Device Name
MRSA-SCREEN
Manufacturer
DENKA SEIKEN'S
Date Cleared
2002-03-27
(324 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K010858Device Name
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
Manufacturer
ID BIOMEDICAL CORP.
Date Cleared
2001-05-24
(63 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990640Device Name
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
Manufacturer
ID BIOMEDICAL CORP.
Date Cleared
1999-07-09
(133 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Product Code :
MYI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ID Biomedical Velogene™ Rapid MRSA Identification Assay is intended as a qualitative assay for the definitive identification of methicillin resistance in presumptively identified cultures of Staphylococcus aureus by detecting the presence of the mecA gene. The presence of the mecA gene confers resistance to methicillin.
Device Description
The Velogene™ Rapid MRSA Identification Assay is a DNA probe based diagnostic device that is based on Cycling Probe™ Technology (CPT) to generate spectrophotometric or visual results. The assay consists of two reagent kits, MRSA Lysis/Cycle Kit and MRSA Microwell Detection Kit.
Ask a Question
Page 1 of 1