510(k) · Cleared
ClearedStreptococcus App. Serological Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · OYZ Group A Streptococcus Nucleic Acid Amplification Assay System
Cleared on Sep 13, 2012 as substantially equivalent to K924715 (Gen-Probe, Inc., 1994) after a 65-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 13, 2012
- Review
- 65 days
- Class
- Class I
- Product code
- OYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924715 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK924715 Gen-Probe Direct Group a Streptococus TestGen-Probe, Inc. · 1994
- This deviceK122019 Streptococcus App. Serological ReagentsMeridian Bioscience, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924715 | Gen-Probe Direct Group a Streptococus Test | Gen-Probe, Inc. | 1994 | — |
| 0 (this device) | K122019 | Streptococcus App. Serological Reagents | Meridian Bioscience, Inc. | 2012 | — |
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 OYZ? 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? (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 |
|---|---|---|---|
| * | K924715 | Gen-Probe Direct Group a Streptococus TestSummary page 3…al Equivalence Information: 1. Predicate device name(s): GEN-PROBEO Group A Streptococcus Direct Test; Catalog 103890 2. Predicate 510(k) numbers: K924715 3. Comparison with predicates: Similarities… | 1994 |
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?
- Its one ancestor has no recall.
How does its category compare?
All OYZ devicesOYZ Group A Streptococcus Nucleic Acid Amplification Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OYZ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OYZ
Too few OYZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OYZ
No recall names OYZ since 2007.
Adverse event reports per year · OYZ
No MAUDE report names OYZ 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 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® Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) in throat swab specimens. The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the…
Read the full statement (118 words)
The illumigene® Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) in throat swab specimens.
The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the illumigene Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
illumigene Group A Strep 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 summary.
https://510kreport.com/device/K122019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122019: Streptococcus App. Serological Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122019
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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