Biosensor, Immunoassay, Cpk Or Isoenzymes
The Immunoassay Biosensor for CPK or Isoenzymes is an in vitro diagnostic device that uses biosensor technology to measure creatine phosphokinase (CPK) and its isoenzymes (particularly CK-MB) in blood, which are biomarkers used in the diagnosis of myocardial infarction and muscle disease. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1215 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MYT
- Device Class
- FDA class 2
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | Dec 15, 2005 | Substantially Equivalent | I-Stat Corporation |
| K033155 | BIOCENTREX CARDIAC PANEL | Jan 12, 2004 | Substantially Equivalent | Biocentrex |
| K984433 | QUANTECH CK-MB ASSAY | Nov 01, 1999 | Substantially Equivalent | Quantech , Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.