510(k) · Cleared
Clearedillumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · OZX Mycoplasma Pneumoniae Dna Assay System
Cleared on Jun 13, 2016 as substantially equivalent to K123423 (Meridian Bioscience, Inc., 2013) and 1 other predicate after an 80-day review. Its family tree reaches back 6 generations to 2008.
- Decided
- Jun 13, 2016
- Review
- 80 days
- Class
- Class II
- Product code
- OZX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to DEN070013 (2008). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 4 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 3 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 2 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 1 generation backK123423 Illumigene Mycoplasama Dna Amplification Assay, and Illumigene…Meridian Bioscience, Inc. · 2013
- This deviceK160829 illumigene Mycoplasma Direct DNA Amplification Assay, illumigene…Meridian Bioscience, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −5 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −4 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −3 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −2 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −1 | K123423 | Illumigene Mycoplasama Dna Amplification Assay, and Illumigene Mycoplasma… | Meridian Bioscience, Inc. | 2013 | — |
| 0 (this device) | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma… | Meridian Bioscience, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 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 OZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K123423 | Illumigene Mycoplasama Dna Amplification Assay, and Illumigene Mycoplasma External…Summary page 4…(21 CFR 866.3980, Product Code OZX, OOI) Predicate Device: illumigene Mycoplasma DNA Amplification Assay; Catalog 280550 K123423, K152800 CONFIDENTIAL Page 7-1 007… | 2013 |
| * | K152800 | illumigene Mycoplasma DNA Amplification AssaySummary page 4…(21 CFR 866.3980, Product Code OZX, OOI) Predicate Device: illumigene Mycoplasma DNA Amplification Assay; Catalog 280550 K123423, K152800 CONFIDENTIAL Page 7-1 007_IG Myco… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All OZX devicesOZX Mycoplasma Pneumoniae Dna Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OZX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OZX
Too few OZX 510(k)s in any year since 2007 to give a median.
Recalls per year · OZX
No recall names OZX since 2007.
Adverse event reports per year · OZX
No MAUDE report names OZX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The illumigene Mycoplasma Direct DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of…
Read the full statement (185 words)
The illumigene Mycoplasma Direct DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.
The illumigene Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.
Results from the illumigene Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma Direct DNA Amplification Assay may be necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160829: illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160829
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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