Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLH — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
113 daysmedian FDA review time
209 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | 2021-07-08 | 569 | 0 |
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | Genzyme Corporation | 2010-12-21 | 134 | 1 |
| K091109 | XPERT C. DIFFICILE | Cepheid | 2009-07-09 | 84 | 0 |
| K090239 | PROGASTRO CD ASSAY | Prodesse, Inc. | 2009-04-16 | 73 | 0 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Techlab, Inc. | 2009-03-26 | 209 | 0 |
| K081920 | BD GENEOHM CDIFF ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 | 169 | 4 |
| K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | bioMerieux, Inc. | 2008-06-11 | 70 | 0 |
| K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 | bioMerieux, Inc. | 2007-12-21 | 141 | 0 |
| K050891 | TOX A/B QUICK CHEK | Techlab, Inc. | 2005-07-25 | 108 | 0 |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Remel, Inc. | 2004-11-15 | 118 | 0 |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | Meridian Bioscience, Inc. | 2004-08-20 | 123 | 1 |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL E | Ivd Research, Inc. | 2004-05-27 | 253 | 0 |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Remel, Inc. | 2004-02-26 | 115 | 0 |
| K030992 | C. DIFF CHEK - 60 | Techlab, Inc. | 2003-07-11 | 105 | 0 |
| K030991 | C. DIFF CHEK - 30 | Techlab, Inc. | 2003-07-11 | 105 | 0 |
| K030404 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2003-04-24 | 77 | 0 |
| K003306 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2000-11-22 | 33 | 0 |
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Meridian Diagnostics, Inc. | 1999-12-10 | 23 | 2 |
| K991829 | CDTOX A OIA | Biostar, Inc. | 1999-11-02 | 158 | 0 |
| K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW | Intracel Corp. | 1999-03-31 | 30 | 0 |
| K980185 | COLORPAC TOXIN A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-07-17 | 178 | 0 |
| K971182 | TOX A/B TEST | Techlab, Inc. | 1997-07-22 | 113 | 0 |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Biomerieux Vitek, Inc. | 1997-04-08 | 123 | 0 |
| K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1997-02-04 | 62 | 0 |
| K955859 | IMMUNOCARD TOXIN A | Meridian Diagnostics, Inc. | 1996-04-18 | 113 | 0 |
| K934493 | PROSPECT MICROPLATE ASSAY | Alexon, Inc. | 1994-09-20 | 370 | 0 |
| K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST | Techlab, Inc. | 1994-04-26 | 174 | 0 |
| K931129 | TECHLAB 1-HOUR TOX-A-TEST | Techlab, Inc. | 1993-09-30 | 209 | 0 |
| K925329 | CULTURETTE BRAND TOXIN CD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-03-24 | 154 | 0 |
| K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | Techlab, Inc. | 1993-02-01 | 202 | 0 |
| K926442 | PREMIER C. DIFFICILE, MODIFICATION | Meridian Diagnostics, Inc. | 1993-01-27 | 42 | 1 |
| K924979 | IMMUNOCARD(TM) C. DIFFICILE | Meridian Diagnostics, Inc. | 1993-01-26 | 117 | 0 |
| K924136 | PREMIER C. DIFFICILE TOXIN A CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 | 62 | 0 |
| K914902 | CLOSTRIDIUM DIFFICILE TOX-A-TEST | Techlab, Inc. | 1992-03-04 | 124 | 0 |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | Vitek Systems, Inc. | 1991-10-11 | 325 | 0 |
| K913229 | BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN | Baxter Diagnostics, Inc. | 1991-08-29 | 38 | 0 |
| K911958 | CYTOCLONE A & B EIA | Cambridge Biotech Corp. | 1991-07-30 | 88 | 0 |
| K903456 | PREMIER-C. DIFFICILE TOXIN A | Meridian Diagnostics, Inc. | 1990-10-01 | 61 | 0 |
| K883560 | CDT CYTOTOXI TEST | Advanced Clinical Diagnostics | 1988-10-25 | 67 | 0 |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Marion Laboratories, Inc. | 1987-04-14 | 42 | 0 |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Marion Laboratories, Inc. | 1986-09-17 | 8 | 0 |
| K852044 | CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI | Marion Laboratories, Inc. | 1985-07-19 | 71 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda