FDA product code MHJ: Cryptosporidium Spp.
MHJ is the FDA product code for cryptosporidium spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel. FDA has cleared 15 510(k) submissions under MHJ, from 10 different applicants. The average 510(k) review took 168 days (median 141). FDA has posted 1 recall for MHJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cryptosporidium Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3220 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MHJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
Compare with all 510(k) review times · Search every MHJ clearance
Top MHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techlab, Inc. | 5 | 2017-07-10 |
| Lmd Laboratories | 2 | 1996-06-07 |
| Trinity Biotech | 1 | 2013-02-08 |
| Remel, Inc. | 1 | 2003-11-14 |
| Ivd Research, Inc. | 1 | 2003-07-10 |
5 more applicants have MHJ clearances. See the full list in Caduvo.
Most recent MHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171078 | Techlab, Inc. | TRI-COMBO PARASITE SCREEN | 2017-07-10 | 90 |
| K121565 | Trinity Biotech | UNI-GOLD CRYPTOSPORIDIUM | 2013-02-08 | 255 |
| K051929 | Techlab, Inc. | GIARDIA/CRYPTOSPORIDIUM CHEK | 2005-11-17 | 127 |
| K052932 | Techlab, Inc. | CRYPTOSPORIDIUM II | 2005-11-04 | 16 |
| K031965 | Remel, Inc. | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | 2003-11-14 | 141 |
Recalls for MHJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-05-09.
Frequently asked questions
What is FDA product code MHJ?
MHJ is the FDA product code for cryptosporidium spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel.
What device class is MHJ?
Class II, regulation 21 CFR 866.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MHJ?
Across 15 cleared submissions the average was 168 days from receipt to decision (median 141).
Which companies have the most MHJ clearances?
Techlab, Inc. (5); Lmd Laboratories (2); Trinity Biotech (1); Remel, Inc. (1); Ivd Research, Inc. (1).
Have MHJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2002-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code MHJ
- Run a recall and safety report across every MHJ manufacturer
- Watch product code MHJ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times