FDA product code KTS: Second Antibody (Species Specific Anti-Animal Gamma Globulin)
KTS is the FDA product code for second antibody (species specific anti-animal gamma globulin). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under KTS, from 3 different applicants. The average 510(k) review took 26 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Second Antibody (Species Specific Anti-Animal Gamma Globulin) |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| 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 KTS clearance
Top KTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Union Carbide Corp. | 2 | 1980-01-11 |
| Burroughs Wellcome Co. | 1 | 1981-12-29 |
| Pcl-Ria, Inc. | 1 | 1978-08-10 |
Most recent KTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813508 | Burroughs Wellcome Co. | SAC-CEL | 1981-12-29 | 14 |
| K792636 | Union Carbide Corp. | CENTRIA RADIOIMMUNOASSAY SEPARATION | 1980-01-11 | 22 |
| K792637 | Union Carbide Corp. | CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) | 1980-01-11 | 22 |
| K781070 | Pcl-Ria, Inc. | SECOND ANTIBODY | 1978-08-10 | 45 |
Recalls for KTS devices
openFDA lists no recalls for product code KTS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J1460 — Injection, gamma globulin, intramuscular, 1 cc
Frequently asked questions
What is FDA product code KTS?
KTS is the FDA product code for second antibody (species specific anti-animal gamma globulin). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is KTS?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTS?
Across 4 cleared submissions the average was 26 days from receipt to decision (median 22).
Which companies have the most KTS clearances?
Union Carbide Corp. (2); Burroughs Wellcome Co. (1); Pcl-Ria, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTS
- Run a recall and safety report across every KTS manufacturer
- Watch product code KTS 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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