FDA product code DDQ: Antigen, Antiserum, Control, Antithrombin Iii
DDQ is the FDA product code for antigen, antiserum, control, antithrombin iii. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under DDQ, from 4 different applicants. The average 510(k) review took 161 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Antiserum, Control, Antithrombin Iii |
| 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 DDQ clearance
Top DDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crestat Diagnostics, Inc. | 1 | 1997-10-20 |
| Baxter Diagnostics, Inc. | 1 | 1994-11-22 |
| Trace Scientific , Ltd. | 1 | 1993-09-30 |
| Ria Diagnostics | 1 | 1978-01-20 |
Most recent DDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972257 | Crestat Diagnostics, Inc. | N-ASSAY TIA ANTITHROMBIN III TEST KIT | 1997-10-20 | 125 |
| K935307 | Baxter Diagnostics, Inc. | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | 1994-11-22 | 385 |
| K932713 | Trace Scientific , Ltd. | TRACE TRANSFERRIN REAGENT | 1993-09-30 | 118 |
| K780012 | Ria Diagnostics | ANTITHROMBIN III RIA | 1978-01-20 | 17 |
Recalls for DDQ devices
openFDA lists no recalls for product code DDQ.
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 DDQ?
DDQ is the FDA product code for antigen, antiserum, control, antithrombin iii. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel.
What device class is DDQ?
Class II, regulation 21 CFR 864.7060. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDQ?
Across 4 cleared submissions the average was 161 days from receipt to decision (median 122).
Which companies have the most DDQ clearances?
Crestat Diagnostics, Inc. (1); Baxter Diagnostics, Inc. (1); Trace Scientific , Ltd. (1); Ria Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDQ
- Run a recall and safety report across every DDQ manufacturer
- Watch product code DDQ 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times