510(k) · Cleared
ClearedGC OIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Biostar, Inc. · LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Cleared on Apr 17, 2003 as substantially equivalent to K951010 (Biostar, Inc., 1995) after a 141-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 17, 2003
- Review
- 141 days
- Class
- Class II
- Product code
- LIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951010 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951010 Chlamydia OiaBiostar, Inc. · 1995 · Recalled
- This deviceK023947 GC OIAThermo Biostar, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951010 | Chlamydia Oia | Biostar, Inc. | 1995 | 2 |
| 0 (this device) | K023947 | GC OIA | Thermo Biostar, Inc. | 2003 | — |
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 LIR? 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 |
|---|---|---|---|
| * | K951010 | Chlamydia OiaSummary page 1…I Manufacturer: Thermo BioStar 510(k) Number: K951010 D. Intended use of device [§807.92(a)(5)]: The Thermo BioStar” GC OIA assay is an Optical ImmunoAssay test for the rapid… | 1995 |
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 a recall.
How does its category compare?
All LIR devicesLIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIR
FDA has decided no LIR device since 2007.
Median 510(k) review, days · LIR
Too few LIR 510(k)s in any year since 2007 to give a median.
Recalls per year · LIR
No recall names LIR since 2007.
Adverse event reports per year · LIR
No MAUDE report names LIR 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 | 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 Thermo BioSta@ GC OIA assay is an Optical ImmunoAssay test for the rapid qualitative detec:tion of gonococcal antigen (L7/L12 ribosomal protein) in female endocervical swab and male urine specimens. Urine specimens must be prepared using an accessory Urine Filtration Device (UFD) for concentration and extraction. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Neisseria gonoiprhoeae antigen. The assay is intended for use with symptomatic females and males, in populations at risk for sexually transmitted diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023947: GC OIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023947
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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