510(k) · Cleared
ClearedStrep B Oia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostar, Inc. · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Jul 6, 1994 after a 195-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 later devices descend from it.
- Decided
- Jul 6, 1994
- Review
- 195 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK936112 Strep B OiaBiostar, Inc. · 1994
- Descendant · cites it directly · 18 of its ownK991828 Strep B OiaBiostar, Inc. · 1999
- Descendant · 2 generations on · 17 of its ownK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- Descendant · 3 generations on · 14 of its ownK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- Descendant · 4 generations on · 4 of its ownK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K991828Strep B OiaBiostar, Inc. · 1999 · cites it directly18descendants
- K022504Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002 · 2 generations on17descendants
- K062948Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006 · 3 generations on14descendants
- K112125Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011 · 4 generations on4descendants
- K090191Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Handylab, Inc. · 2010 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| +1 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| +2 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| +3 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| +4 | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| +4 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GTY? 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 GTY device
- #1 K260342 AllTest Strep A Rapid Testscore 11.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991828 | Strep B Oia | 1999 | 18 |
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, K991828 (Biostar, Inc., 1999) has gone furthest, with 18 descendants of its own.
How does its category compare?
All GTY devicesGTY Antigens, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GTY
Too few GTY 510(k)s in any year since 2007 to give a median.
Recalls per year · GTY
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTY
94in 2025
MAUDE reports naming product code GTY, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 4 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 1 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 1 | — | 0 | 94 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K936112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K936112: Strep B Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936112
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026