510(k) · Cleared
ClearedCdtox a Oia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostar, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Nov 2, 1999 as substantially equivalent to K903456 (Meridian Diagnostics, Inc., 1990) after a 158-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 2, 1999
- Review
- 158 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903456 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK903456 Premier-C. Difficile Toxin aMeridian Diagnostics, Inc. · 1990
- This deviceK991829 Cdtox a OiaBiostar, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903456 | Premier-C. Difficile Toxin a | Meridian Diagnostics, Inc. | 1990 | — |
| 0 (this device) | K991829 | Cdtox a Oia | Biostar, Inc. | 1999 | — |
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 LLH? 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 LLH device
- #1 K193490 SensiTox C. difficile Toxin Testscore 1.6 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K903456 | Premier-C. Difficile Toxin aSummary page 1…a)(3)]: TRADE OR PROPRIETARY NAME: PREMIER™ C. difficile Toxin A REGULATORY CLASS: Class ] PRODUCT CODE: 83LLH MANUFACTURER: Meridian Diagnostics, Inc. S10(k) NUMBER: K903456 Note: Performance of the CdTOX A OIA product was also established versus cytotoxicity assay. D. Description of device [§807.92(… | 1990 |
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 LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LLH
84in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLH
1in 2025
MAUDE reports naming product code LLH, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 0 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 2 | 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 | 1 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioStar® CdTOX A OIA assay is an Optical ImmunoAssay test for the rapid qualitative detection of Clostridium difficile Toxin A in human fecal samples from patients suspected of having Clostridium difficile associated disease (CDAD). This test is intended for in vitro diagnostic use as an aid in the diagnosis of CDAD.
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/K991829 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991829: Cdtox a Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991829
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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