FDA product code JST: Kit, Fastidious Organisms
JST is the FDA product code for kit, fastidious organisms. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under JST, from 5 different applicants. The average 510(k) review took 45 days (median 42). FDA has posted 6 recalls for JST devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Fastidious Organisms |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JST clearance
Top JST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Austin Biological Laboratories | 2 | 1983-08-12 |
| Becton Dickinson Microbiology Systems | 1 | 1996-08-02 |
| Dms Products, Inc. | 1 | 1986-03-04 |
| Oxoid U.S.A., Inc. | 1 | 1984-05-11 |
| Granite Diagnostics, Inc. | 1 | 1983-05-16 |
Most recent JST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962423 | Becton Dickinson Microbiology Systems | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | 1996-08-02 | 39 |
| K854732 | Dms Products, Inc. | API 50 CHB (CULTURE MEDIA) | 1986-03-04 | 99 |
| K841661 | Oxoid U.S.A., Inc. | SYNTHETIC BROTH A.O.A.C. | 1984-05-11 | 18 |
| K832239 | Austin Biological Laboratories | RIM-HAEMOPHILUS 2 | 1983-08-12 | 46 |
| K832051 | Austin Biological Laboratories | RIM-HAEMOPHILUS 1 & 2 | 1983-08-12 | 49 |
Recalls for JST devices
6 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2022 | 3 |
Frequently asked questions
What is FDA product code JST?
JST is the FDA product code for kit, fastidious organisms. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JST?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JST?
Across 6 cleared submissions the average was 45 days from receipt to decision (median 42).
Which companies have the most JST clearances?
Austin Biological Laboratories (2); Becton Dickinson Microbiology Systems (1); Dms Products, Inc. (1); Oxoid U.S.A., Inc. (1); Granite Diagnostics, Inc. (1).
Have JST devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JST
- Run a recall and safety report across every JST manufacturer
- Watch product code JST 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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