# K042357: Idi-Mrsa Assay

- Pathway: 510(k) (Special)
- Applicant: Infectio Diagnostic (I.D.I.), Inc.
- Decided: Oct 22, 2004 after 52 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices 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) Infectio Diagnostic Inc. IDI-MRSA Assay: named in the summary without a submission number

## Most influential descendants
- K071026: BD Geneohm Staphsr Assay (2007), 9 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
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), 2 descendants of its own

## Recalls of this device
- Nov 11, 2008 · Not classified · Z-1963-2009: BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.
- Jul 21, 2008 · Not classified · Z-0226-2009: BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphy
- Jul 21, 2008 · Not classified · Z-0225-2009: BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphy

## Indications for use
IDI-MRSATM 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/K042357
Methodology: https://510kreport.com/methodology