FDA product code MYT: Biosensor, Immunoassay, Cpk Or Isoenzymes
MYT is the FDA product code for biosensor, immunoassay, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under MYT, from 3 different applicants. The average 510(k) review took 208 days (median 197). FDA has posted 1 recall for MYT devices.
Classification
| Field | Value |
|---|---|
| Device name | Biosensor, Immunoassay, Cpk Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1215 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top MYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| I-Stat Corporation | 1 | 2005-12-15 |
| Biocentrex | 1 | 2004-01-12 |
| Quantech , Ltd. | 1 | 1999-11-01 |
Most recent MYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051433 | I-Stat Corporation | I-STAT CREATINE KINASE MB (CK-MB) | 2005-12-15 | 197 |
| K033155 | Biocentrex | BIOCENTREX CARDIAC PANEL | 2004-01-12 | 104 |
| K984433 | Quantech , Ltd. | QUANTECH CK-MB ASSAY | 1999-11-01 | 322 |
Recalls for MYT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-02-01.
Frequently asked questions
What is FDA product code MYT?
MYT is the FDA product code for biosensor, immunoassay, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is MYT?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYT?
Across 3 cleared submissions the average was 208 days from receipt to decision (median 197).
Which companies have the most MYT clearances?
I-Stat Corporation (1); Biocentrex (1); Quantech , Ltd. (1).
Have MYT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code MYT
- Run a recall and safety report across every MYT manufacturer
- Watch product code MYT 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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