FDA product code DFT: Igm, Antigen, Antiserum, Control
DFT is the FDA product code for igm, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 33 510(k) submissions under DFT, from 28 different applicants. The average 510(k) review took 46 days (median 32). FDA has posted 4 recalls for DFT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Igm, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DFT clearance
Top DFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Laboratories, Inc. | 3 | 1986-02-28 |
| Isolab, Inc. | 2 | 1990-04-12 |
| Gelco Diagnostics, Inc. | 2 | 1983-10-31 |
| Icl Scientific | 2 | 1981-05-08 |
| Abbott Laboratories | 1 | 1998-11-04 |
23 more applicants have DFT clearances. See the full list in Caduvo.
Most recent DFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983132 | Abbott Laboratories | IGM | 1998-11-04 | 57 |
| K962201 | Instrumentation Laboratory CO | QUANTEX IGM | 1996-09-25 | 110 |
| K955797 | Randox Laboratories, Ltd. | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | 1996-04-05 | 105 |
| K945522 | Beckman-Diagnostic Systems Group | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | 1994-12-12 | 32 |
| K901453 | Isolab, Inc. | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | 1990-04-12 | 16 |
Recalls for DFT devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-11-01.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code DFT?
DFT is the FDA product code for igm, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DFT?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFT?
Across 33 cleared submissions the average was 46 days from receipt to decision (median 32).
Which companies have the most DFT clearances?
Kallestad Laboratories, Inc. (3); Isolab, Inc. (2); Gelco Diagnostics, Inc. (2); Icl Scientific (2); Abbott Laboratories (1).
Have DFT devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code DFT
- Run a recall and safety report across every DFT manufacturer
- Watch product code DFT 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 Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times