FDA product code GJT: Plasma, Coagulation Factor Deficient
GJT is the FDA product code for plasma, coagulation factor deficient. It is a Class II device, regulated under 21 CFR 864.7290 and reviewed by the Hematology panel. FDA has cleared 79 510(k) submissions under GJT, 1 in the last five years, from 20 different applicants. The average 510(k) review took 116 days (median 66). FDA has posted 3 recalls for GJT devices.
Classification
| Field | Value |
|---|---|
| Device name | Plasma, Coagulation Factor Deficient |
| Device class | Class II |
| Regulation | 21 CFR 864.7290 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GJT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 27 |
| 2023 | 1 | 359 |
Compare with all 510(k) review times · Search every GJT clearance
Top GJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 10 | 2018-03-22 |
| Medical Diagnostic Technologies, Inc. | 10 | 1990-01-25 |
| American Bioproducts Co. | 9 | 1996-10-25 |
| Sigma Chemical Co. | 8 | 1990-03-06 |
| Precision Biologicals, Inc. | 7 | 1999-01-13 |
15 more applicants have GJT clearances. See the full list in Caduvo.
Most recent GJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222831 | Precision Biologic, Inc. | CRYOcheck Factor VIII Deficient Plasma with VWF | 2023-09-13 | 359 |
| K180486 | Instrumentation Laboratory CO | HemosIL Factor XII Deficient Plasma | 2018-03-22 | 27 |
| K102908 | R2 Diagnostics, Inc. | NOFACT IX | 2011-12-19 | 444 |
| K102851 | R2 Diagnostics, Inc. | NOFACT VIII | 2011-12-19 | 446 |
| K110237 | Instrumentation Laboratory CO | HEMOSIL FACTOR VIII DEFICIENT PLASMA | 2011-07-08 | 163 |
Recalls for GJT devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-05-11.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u.
Frequently asked questions
What is FDA product code GJT?
GJT is the FDA product code for plasma, coagulation factor deficient. It is a Class II device, regulated under 21 CFR 864.7290 and reviewed by the Hematology panel.
What device class is GJT?
Class II, regulation 21 CFR 864.7290. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJT?
Across 79 cleared submissions the average was 116 days from receipt to decision (median 66).
Which companies have the most GJT clearances?
Instrumentation Laboratory CO (10); Medical Diagnostic Technologies, Inc. (10); American Bioproducts Co. (9); Sigma Chemical Co. (8); Precision Biologicals, Inc. (7).
Have GJT devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2015-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GJT
- Run a recall and safety report across every GJT manufacturer
- Watch product code GJT 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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