FDA product code JTA: Monitor, Microbial Growth
JTA is the FDA product code for monitor, microbial growth. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under JTA, from 6 different applicants. The average 510(k) review took 69 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Microbial Growth |
| Device class | Class I |
| Regulation | 21 CFR 866.2560 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JTA clearance
Top JTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 6 | 1991-03-11 |
| Becton Dickinson Diagnostic Instrument Systems | 1 | 1996-11-21 |
| American Micro Scan | 1 | 1984-09-12 |
| Marion Laboratories, Inc. | 1 | 1984-01-13 |
| Applied Polytechnology, Inc. | 1 | 1984-01-13 |
1 more applicants have JTA clearances. See the full list in Caduvo.
Most recent JTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954923 | Becton Dickinson Diagnostic Instrument Systems | BACTEC FUNGAL MEDIUM | 1996-11-21 | 392 |
| K910835 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC NR-860 | 1991-03-11 | 12 |
| K865021 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | 1987-02-06 | 45 |
| K853011 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | 1985-07-30 | 14 |
| K842874 | American Micro Scan | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | 1984-09-12 | 51 |
Recalls for JTA devices
openFDA lists no recalls for product code JTA.
Frequently asked questions
What is FDA product code JTA?
JTA is the FDA product code for monitor, microbial growth. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel.
What device class is JTA?
Class I, regulation 21 CFR 866.2560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTA?
Across 11 cleared submissions the average was 69 days from receipt to decision (median 42).
Which companies have the most JTA clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (6); Becton Dickinson Diagnostic Instrument Systems (1); American Micro Scan (1); Marion Laboratories, Inc. (1); Applied Polytechnology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JTA
- Run a recall and safety report across every JTA manufacturer
- Watch product code JTA 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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