System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
The Genotypic Detection Test System for Resistant Markers in Staphylococcus Colonies is a microbiology diagnostic device that uses molecular genotyping techniques to identify antibiotic resistance markers, such as mecA for methicillin resistance (MRSA), in Staphylococcus bacterial colonies. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.1640 (Microbiology specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MYI
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140619 | MECA XPRESSFISH | Oct 10, 2014 | Substantially Equivalent | Advandx, Inc. |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | Sep 03, 2014 | Substantially Equivalent | Alere Scarborough, Inc. |
| K121905 | ALERE PBP2A TEST | Jul 26, 2012 | Substantially Equivalent | Alere Scarborough, Inc. |
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | Apr 14, 2010 | Substantially Equivalent | Binax, Inc. |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | Feb 24, 2010 | Substantially Equivalent | Binax, Inc. |
| K062864 | MASTALEX -MRSA, MODEL RST501 | Oct 18, 2006 | Substantially Equivalent | Mast Group , Ltd. |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | Apr 02, 2002 | Substantially Equivalent | Oxoid , Ltd. |
| K011400 | MRSA-SCREEN | Mar 27, 2002 | Substantially Equivalent | Denka Seiken'S |
| K010858 | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION | May 24, 2001 | Substantially Equivalent | Id Biomedical Corp. |
| K990640 | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | Jul 09, 1999 | Substantially Equivalent | Id Biomedical Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.