# K990640: Velogene Rapid Mrsa Identification Assay

- Pathway: 510(k) (Traditional)
- Applicant: Id Biomedical Corp.
- Decided: Jul 9, 1999 after 133 days
- Product code: MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Oxacillin Screen Agar: named in the summary without a submission number

## Indications for use
The ID Biomedical Velogene™ Rapid MRSA Identification Assay is a qualitative DNA probe test which utilizes Cycling Probe™ Technology (CPT) to detect the mecA gene in isolated colonies of presumptively identified Staphylococcus aureus.

Source page: https://510kreport.com/device/K990640
Methodology: https://510kreport.com/methodology