# K033415: Idi-Mrsa

- Pathway: 510(k) (Traditional)
- Applicant: Infectio Diagnostic (I.D.I.), Inc.
- Decided: Mar 18, 2004 after 143 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850291 (1985). 2 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011710: Oxoid PBP2 1 Latex Agglutination Test, Oxoid, Ltd. (2002) Summary page 2.
- K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics, Remel Co. (1985) Summary page 2.

## Most influential descendants
- K070462: Xpert Mrsa (2007), 10 descendants of its own
- K093346: BD Geneohm Mrsa Acp Assay (2009), 7 descendants of its own
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), 4 descendants of its own
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), 2 descendants of its own
- K112937: Mrsa/SA Elite MGB (2012), 1 descendant of its own

## Recalls of this device
- Jul 22, 2005 · Not classified · Z-1378-05: A problem in the software has the potential to be associated with the incorrect reporting of sample results.

## Indications for use
IDI-MRSA TM 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-MRSATM assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K033415
Methodology: https://510kreport.com/methodology