FDA product code JWX: Kit, Screening, Staphylococcus Aureus
JWX is the FDA product code for kit, screening, staphylococcus aureus. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 20 510(k) submissions under JWX, from 20 different applicants. The average 510(k) review took 78 days (median 36). FDA has posted 7 recalls for JWX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Screening, Staphylococcus Aureus |
| 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 JWX clearance
Top JWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Binax, Inc. | 1 | 2009-12-16 |
| Oxoid , Ltd. | 1 | 1997-09-08 |
| Remel, L.P. | 1 | 1997-02-07 |
| Murex Diagnostics Limitd | 1 | 1995-06-01 |
| Trinity Laboratories, Inc. | 1 | 1993-08-10 |
15 more applicants have JWX clearances. See the full list in Caduvo.
Most recent JWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090964 | Binax, Inc. | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | 2009-12-16 | 254 |
| K972030 | Oxoid , Ltd. | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | 1997-09-08 | 98 |
| K964315 | Remel, L.P. | REMEL STAPH LATEX KIT | 1997-02-07 | 101 |
| K945538 | Murex Diagnostics Limitd | STAPHAUREX PLUS(TM) | 1995-06-01 | 199 |
| K926173 | Trinity Laboratories, Inc. | STAPH-A-LEX(TM) SYSTEM | 1993-08-10 | 245 |
Recalls for JWX devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code JWX?
JWX is the FDA product code for kit, screening, staphylococcus aureus. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JWX?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JWX?
Across 20 cleared submissions the average was 78 days from receipt to decision (median 36).
Which companies have the most JWX clearances?
Binax, Inc. (1); Oxoid , Ltd. (1); Remel, L.P. (1); Murex Diagnostics Limitd (1); Trinity Laboratories, Inc. (1).
Have JWX devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JWX
- Run a recall and safety report across every JWX manufacturer
- Watch product code JWX 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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