Prothrombin Fragment 1.2
The Prothrombin Fragment 1.2 assay is an in vitro diagnostic test used to measure the concentration of prothrombin fragment 1.2 in blood, a marker of thrombin generation and coagulation activation that is clinically useful in evaluating thrombotic risk and monitoring anticoagulation therapy. It is classified as a Class 2 device under 21 CFR 864.7320 within the Hematology specialty and requires 510(k) premarket notification. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- MIF
- Device Class
- FDA class 2
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dec 10, 2004 | Substantially Equivalent | Dade Behring, Inc. |
| K964934 | THROMBONOSTIKA F1.2 | Mar 18, 1997 | Substantially Equivalent | Organon Teknika Corp. |
| K962176 | TPP | Oct 18, 1996 | Substantially Equivalent | Panbio, Inc. |
| K922934 | ENZYGNOST F 1+2 | Nov 16, 1992 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Jun 04, 1992 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K911434 | THROMBONOSTIKA F1.2 | Oct 31, 1991 | Substantially Equivalent | Organon Teknika Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.