FDA product code JSX: Kit, Identification, Neisseria Gonorrhoeae
JSX is the FDA product code for kit, identification, neisseria gonorrhoeae. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under JSX, from 16 different applicants. The average 510(k) review took 73 days (median 59). 2 PMA applications cite this product code. FDA has posted 1 recall for JSX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Neisseria Gonorrhoeae |
| 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 JSX clearance
Top JSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtex Laboratories, Inc. | 1 | 1996-09-18 |
| Remel Co. | 1 | 1992-11-02 |
| Kev Connecticut Diagnostics, Inc. | 1 | 1991-10-11 |
| Austin Biological Laboratories | 1 | 1988-08-25 |
| Innovative Diagnostic Systems, Inc. | 1 | 1988-05-18 |
11 more applicants have JSX clearances. See the full list in Caduvo.
Most recent JSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960759 | Medtex Laboratories, Inc. | GONOPOX TEST KIT | 1996-09-18 | 205 |
| K923566 | Remel Co. | NIZYME TEST KIT | 1992-11-02 | 108 |
| K913456 | Kev Connecticut Diagnostics, Inc. | VISI-NEISSERIA | 1991-10-11 | 67 |
| K880511 | Austin Biological Laboratories | XACT NEISSERIA | 1988-08-25 | 198 |
| K881501 | Innovative Diagnostic Systems, Inc. | MODIFIED IDS RAPID NH SYSTEM | 1988-05-18 | 37 |
Recalls for JSX devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code JSX?
JSX is the FDA product code for kit, identification, neisseria gonorrhoeae. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSX?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSX?
Across 16 cleared submissions the average was 73 days from receipt to decision (median 59).
Which companies have the most JSX clearances?
Medtex Laboratories, Inc. (1); Remel Co. (1); Kev Connecticut Diagnostics, Inc. (1); Austin Biological Laboratories (1); Innovative Diagnostic Systems, Inc. (1).
Have JSX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JSX
- Run a recall and safety report across every JSX manufacturer
- Watch product code JSX 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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