FDA product code JTT: Susceptibility Test Powders, Antimicrobial
JTT is the FDA product code for susceptibility test powders, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 14 510(k) submissions under JTT, from 9 different applicants. The average 510(k) review took 75 days (median 74). 10 PMA applications cite this product code. FDA has posted 1 recall for JTT devices.
Classification
| Field | Value |
|---|---|
| Device name | Susceptibility Test Powders, Antimicrobial |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JTT clearance
Top JTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1989-12-01 |
| Merck, Sharp & Dohme | 3 | 1988-05-04 |
| Miles Pharmaceuticals | 2 | 1987-06-15 |
| Accumed Intl., Inc. | 1 | 1998-12-17 |
| Pasco Laboratories, Inc. | 1 | 1994-06-13 |
4 more applicants have JTT clearances. See the full list in Caduvo.
Most recent JTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983310 | Accumed Intl., Inc. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | 1998-12-17 | 87 |
| K935805 | Pasco Laboratories, Inc. | PASCO MIC AND MIC/ID PANELS | 1994-06-13 | 193 |
| K895362 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | 1989-12-01 | 94 |
| K880574 | Merck, Sharp & Dohme | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | 1988-05-04 | 84 |
| K872081 | Miles Pharmaceuticals | CIPRO (TM) DIAGNOSTIC POWDER | 1987-06-15 | 17 |
Recalls for JTT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-24.
Frequently asked questions
What is FDA product code JTT?
JTT is the FDA product code for susceptibility test powders, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is JTT?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTT?
Across 14 cleared submissions the average was 75 days from receipt to decision (median 74).
Which companies have the most JTT clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Merck, Sharp & Dohme (3); Miles Pharmaceuticals (2); Accumed Intl., Inc. (1); Pasco Laboratories, Inc. (1).
Have JTT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JTT
- Run a recall and safety report across every JTT manufacturer
- Watch product code JTT 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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