FDA product code LLH: Reagents, Clostridium Difficile Toxin
LLH is the FDA product code for reagents, clostridium difficile toxin. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 42 510(k) submissions under LLH, from 22 different applicants. The average 510(k) review took 130 days (median 113). FDA has posted 11 recalls for LLH devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Clostridium Difficile Toxin |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LLH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 569 |
Compare with all 510(k) review times · Search every LLH clearance
Top LLH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techlab, Inc. | 11 | 2009-03-26 |
| Meridian Diagnostics, Inc. | 6 | 1999-12-10 |
| Marion Laboratories, Inc. | 3 | 1987-04-14 |
| bioMerieux, Inc. | 2 | 2008-06-11 |
| Remel, Inc. | 2 | 2004-11-15 |
17 more applicants have LLH clearances. See the full list in Caduvo.
Most recent LLH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193490 | First Light Diagnostics, Inc. | SensiTox C. difficile Toxin Test | 2021-07-08 | 569 |
| K102242 | Genzyme Corporation | OSOM C. DIFFICILE TOXIN A/B TEST | 2010-12-21 | 134 |
| K091109 | Cepheid | XPERT C. DIFFICILE | 2009-07-09 | 84 |
| K090239 | Prodesse, Inc. | PROGASTRO CD ASSAY | 2009-04-16 | 73 |
| K082499 | Techlab, Inc. | C. DIFF QUIK CHEK COMPLETE | 2009-03-26 | 209 |
Recalls for LLH devices
11 product recalls in 8 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-22.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code LLH?
LLH is the FDA product code for reagents, clostridium difficile toxin. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LLH?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LLH?
Across 42 cleared submissions the average was 130 days from receipt to decision (median 113).
Which companies have the most LLH clearances?
Techlab, Inc. (11); Meridian Diagnostics, Inc. (6); Marion Laboratories, Inc. (3); bioMerieux, Inc. (2); Remel, Inc. (2).
Have LLH devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2021-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code LLH
- Run a recall and safety report across every LLH manufacturer
- Watch product code LLH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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