510(k) · Cleared
Recalled · 2008Idi-Mrsa Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infectio Diagnostic (I.D.I.), Inc. · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Oct 22, 2004 after a 52-day review. The FDA summary names its predicate without a number. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 22, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 3
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK042357 Idi-Mrsa AssayInfectio Diagnostic (I.D.I.), Inc. · 2004
- Descendant · cites it directly · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · cites it directly · 7 of its ownK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 3 generations on · 2 of its ownK133605 BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · cites it directly9descendants
- K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · cites it directly7descendants
- K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · 2 generations on4descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · 2 generations on3descendants
- K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042357 | Idi-Mrsa Assay | Infectio Diagnostic (I.D.I.), Inc. | 2004 | — |
| +1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +1 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| +2 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| +2 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +3 | K133605 | BD Max Mrsa XT, BD Max Instrument | Geneohm Sciences Canada, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQX device
- #1 K243625 Xpert MRSA/SA SSTIscore 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Infectio Diagnostic Inc. IDI-MRSA Assay Named without a submission number |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2008 | Not classified | Z-1963-2009 | Other | 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 | Nonconforming Material/Component | 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 Staphylococcus aureus. The potential health… |
| Jul 21, 2008 | Not classified | Z-0225-2009 | Nonconforming Material/Component | 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 Staphylococcus aureus. The potential health… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071026 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2007) has gone furthest, with 9 descendants of its own.
How does its category compare?
All NQX devicesNQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQX
75in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQX
15in 2025
MAUDE reports naming product code NQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 70 | 1 | 1 |
| 2011 | 2 | — | 6 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 75 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 2 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (110 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042357: Idi-Mrsa Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026