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 Aug 19, 1999 as substantially equivalent to K936112 (Biostar, Inc., 1994) after an 83-day review. Its family tree reaches back 1 generation to 1994. 18 later devices descend from it.
- Decided
- Aug 19, 1999
- Review
- 83 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936112 (1994). 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK936112 Strep B OiaBiostar, Inc. · 1994
- This deviceK991828 Strep B OiaBiostar, Inc. · 1999
- Descendant · cites it directly · 17 of its ownK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- Descendant · 2 generations on · 14 of its ownK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- Descendant · 3 generations on · 4 of its ownK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK121539 Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems…Cepheid · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K022504Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002 · cites it directly17descendants
- K062948Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006 · 2 generations on14descendants
- K112125Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011 · 3 generations on4descendants
- K090191Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Handylab, Inc. · 2010 · 3 generations on4descendants
- K121539Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert…Cepheid · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| 0 (this device) | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| +1 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| +2 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| +3 | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| +3 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
| +3 | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… | Cepheid | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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 |
|---|---|---|---|
| * | K936112 | Strep B OiaSummary page 1…laiming equivalence [§807.92(a)(3)]: TRADE OR PROPRIETARY NAME: STREP B OIA® REGULATORY CLASS: Class 1 PRODUCT CODE: 83GTY MANUFACTURER: BioStar, Inc. 510(k) NUMBER: K936112 Note: Performance of the STREP B OIA product was established versus Lim broth as the reference standard. D. Description of devi… | 1994 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022504 | Idi-Strep B Assay | 2002 | 17 |
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.
- Of its descendants, K022504 (Infectio Diagnostic, Inc., 2002) has gone furthest, with 17 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 | — |
What is it indicated for?
The BioStar® STREP B OIA® assay is an Optical InmunoAssay (OIA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991828: Strep B Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991828
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