510(k) · Cleared
Recalled · 2005Idi-Mrsa
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 Mar 18, 2004 as substantially equivalent to K011710 (Oxoid, Ltd., 2002) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1985. 14 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2004
- Review
- 143 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850291 (1985). 2 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- This deviceK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004
- Descendant · cites it directly · 10 of its ownK070462 Xpert MrsaCepheid · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- Descendant · 4 generations on · 2 of its ownK133605 BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK112937 Mrsa/SA Elite MGBElitech · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K070462Xpert MrsaCepheid · 2007 · cites it directly10descendants
- K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · 2 generations on7descendants
- K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · 3 generations on4descendants
- K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · 4 generations on2descendants
- K112937Mrsa/SA Elite MGBElitech · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| 0 (this device) | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | — |
| +1 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| +2 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| +3 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| +4 | K133605 | BD Max Mrsa XT, BD Max Instrument | Geneohm Sciences Canada, Inc. | 2013 | 1 |
| +3 | K112937 | Mrsa/SA Elite MGB | Elitech | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K011710 | Oxoid PBP2 1 Latex Agglutination TestSummary page 2…mples. Substantial Equivalence: The Infectio Diagnostic Inc. IDI-MRSATM assay has been found to be substantially equivalent to the Oxoid PBP2' Latex Agglutination Test (K01 1710) and to the culture technique consisting of primary isolation on mannitol salt agar followed by the oxacillin screen agar [Muelle… | 2002 |
| * | K850291 | Mueller Hinton Agar W/4% Nacl W/AntibioticsSummary page 2…consisting of primary isolation on mannitol salt agar followed by the oxacillin screen agar [Mueller Hinton Agar supplemented with 4% NaCl and 6 ptg/ml oxacillin (Remel, K850291)] for confirmed isolates of S. aureus. The IDI-MRSATM assay is conducted directly on nasal swab specimens; determination of methi… | 1985 |
What descends from it? (14)
See all 143 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 |
|---|---|---|---|---|
| Jul 22, 2005 | Not classified | Z-1378-05 | Other | A problem in the software has the potential to be associated with the incorrect reporting of sample results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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-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…
Read the full statement (111 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033415: Idi-Mrsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033415
Report an extraction error
Are you the manufacturer?
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