FDA product code MCB: Antigen, C. Difficile
MCB is the FDA product code for antigen, c. difficile. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under MCB, from 8 different applicants. The average 510(k) review took 145 days (median 138). FDA has posted 4 recalls for MCB devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, C. Difficile |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCB clearance
Top MCB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 2 | 2011-12-16 |
| Meridian Diagnostics, Inc. | 2 | 1992-10-19 |
| Biomerieux S.A. | 1 | 2013-10-09 |
| Techlab, Inc. | 1 | 2006-04-26 |
| Biosite Incorporated | 1 | 1998-03-20 |
3 more applicants have MCB clearances. See the full list in Caduvo.
Most recent MCB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132010 | Biomerieux S.A. | VIDAS C DIFFICILE GDH | 2013-10-09 | 100 |
| K112048 | Meridian Bioscience, Inc. | IMMUNOCARD C. DIFFICILE GDH | 2011-12-16 | 151 |
| K110620 | Meridian Bioscience, Inc. | PREMIER C. DIFFICILE GDH | 2011-05-03 | 61 |
| K053572 | Techlab, Inc. | C. DIFF QUIK CHEK | 2006-04-26 | 125 |
| K974881 | Biosite Incorporated | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | 1998-03-20 | 80 |
Recalls for MCB devices
4 product recalls in 3 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 MCB?
MCB is the FDA product code for antigen, c. difficile. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is MCB?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCB?
Across 10 cleared submissions the average was 145 days from receipt to decision (median 138).
Which companies have the most MCB clearances?
Meridian Bioscience, Inc. (2); Meridian Diagnostics, Inc. (2); Biomerieux S.A. (1); Techlab, Inc. (1); Biosite Incorporated (1).
Have MCB devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2021-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MCB
- Run a recall and safety report across every MCB manufacturer
- Watch product code MCB 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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