FDA product code JPE: Antithrombin Iii, Two Stage Clotting Time Assay
JPE is the FDA product code for antithrombin iii, two stage clotting time assay. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under JPE. The average 510(k) review took 295 days (median 295).
Classification
| Field | Value |
|---|---|
| Device name | Antithrombin Iii, Two Stage Clotting Time Assay |
| Device class | Class II |
| Regulation | 21 CFR 864.7060 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JPE clearance
Top JPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 1 | 1994-04-19 |
Most recent JPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933125 | Behring Diagnostics, Inc. | BERICHROM ANTITHROMBIN III (A) | 1994-04-19 | 295 |
Recalls for JPE devices
openFDA lists no recalls for product code JPE.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7197 — Antithrombin iii (human), per i.u.
Frequently asked questions
What is FDA product code JPE?
JPE is the FDA product code for antithrombin iii, two stage clotting time assay. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel.
What device class is JPE?
Class II, regulation 21 CFR 864.7060. Typical premarket route: 510(k).
How long does a 510(k) take for product code JPE?
Across 1 cleared submissions the average was 295 days from receipt to decision (median 295).
Which companies have the most JPE clearances?
Behring Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPE
- Run a recall and safety report across every JPE manufacturer
- Watch product code JPE 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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