FDA product code JXA: Kit, Screening, Urine
JXA is the FDA product code for kit, screening, urine. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 44 510(k) submissions under JXA, from 34 different applicants. The average 510(k) review took 95 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Screening, Urine |
| 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 JXA clearance
Top JXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Convenience Products, Inc. | 4 | 1994-09-09 |
| Izon Business Products, Inc. | 3 | 1995-04-14 |
| Los Alamos Diagnostics | 3 | 1988-09-07 |
| Applied Polytechnology, Inc. | 3 | 1986-04-04 |
| Marion Laboratories, Inc. | 2 | 1985-06-04 |
29 more applicants have JXA clearances. See the full list in Caduvo.
Most recent JXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011043 | Osmetech | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) | 2001-11-30 | 239 |
| K981084 | Diatech Diagnostics,Inc. | URISCREEN | 1998-10-07 | 196 |
| K972676 | Combact Diagnostic Systems , Ltd. | URINE SCREENING DEVICE | 1998-02-23 | 222 |
| K952246 | Tri-Tech, Inc. | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | 1995-06-20 | 39 |
| K950257 | Izon Business Products, Inc. | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | 1995-04-14 | 81 |
Recalls for JXA devices
openFDA lists no recalls for product code JXA.
Frequently asked questions
What is FDA product code JXA?
JXA is the FDA product code for kit, screening, urine. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JXA?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JXA?
Across 44 cleared submissions the average was 95 days from receipt to decision (median 60).
Which companies have the most JXA clearances?
Clinical Convenience Products, Inc. (4); Izon Business Products, Inc. (3); Los Alamos Diagnostics (3); Applied Polytechnology, Inc. (3); Marion Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JXA
- Run a recall and safety report across every JXA manufacturer
- Watch product code JXA 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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