510(k) · Cleared
Clearedillumigene Mycoplasma DNA Amplification Assay
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 Oct 23, 2015 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 23, 2015
- Review
- 25 days
- Class
- Class II
- Product code
- OZX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK152800 illumigene Mycoplasma DNA Amplification AssayMeridian Bioscience, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK160829 illumigene Mycoplasma Direct DNA Amplification Assay, illumigene…Meridian Bioscience, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160829illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct…Meridian Bioscience, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K152800 | illumigene Mycoplasma DNA Amplification Assay | Meridian Bioscience, Inc. | 2015 | — |
| +1 | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma… | Meridian Bioscience, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct… | 2016 | 0 |
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?
- Of its descendants, K160829 (Meridian Bioscience, Inc., 2016) has gone furthest, with 0 descendants of its own.
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. 2015, 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 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 and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment…
Read the full statement (204 words)
The illumigene Mycoplasma 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 and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.
The illumigene Mycoplasma 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 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 DNA Amplification Assay may be necessary.
illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K152800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152800: illumigene Mycoplasma DNA Amplification Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152800
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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