510(k) · Cleared
ClearedPrima System - Old, Bartels Elisa - New
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intracel Corp. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Mar 31, 1999 as substantially equivalent to K913229 (Baxter Diagnostics, Inc., 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 31, 1999
- Review
- 30 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913229 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913229 Bartels Clostridium Difficile Toxin a Enzym ImmunBaxter Diagnostics, Inc. · 1991
- This deviceK990664 Prima System - Old, Bartels Elisa - NewIntracel Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913229 | Bartels Clostridium Difficile Toxin a Enzym Immun | Baxter Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K990664 | Prima System - Old, Bartels Elisa - New | Intracel Corp. | 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 |
|---|---|---|---|
| * | K913229 | Bartels Clostridium Difficile Toxin a Enzym ImmunSummary page 1…ls PRIMA System™ Clostridium difficile Toxin A Enzyme Immunoassay (EIA). Trade/Proprietary Name: PRIMA System — old Bartels ELISA - new Device Class: Class | 510(k): K913229 F:\Submissions\510K\Improved C ditticile EIA\510(k)K990664amendment031999.doc INTRACEL Corporation 03/19/99 (e… | 1991 |
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?
Bartels Clostridium difficille Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficille Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficille-associated disease.
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/K990664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990664: Prima System - Old, Bartels Elisa - New.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990664
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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