FDA product code JXN: Enzyme Immunoassay, Propoxyphene
JXN is the FDA product code for enzyme immunoassay, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel. FDA has cleared 22 510(k) submissions under JXN, from 17 different applicants. The average 510(k) review took 82 days (median 69). FDA has posted 2 recalls for JXN devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Propoxyphene |
| Device class | Class II |
| Regulation | 21 CFR 862.3700 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JXN clearance
Top JXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 4 | 2000-02-01 |
| Abbott Laboratories | 2 | 2002-03-20 |
| Roche Diagnostic Systems, Inc. | 2 | 1998-12-11 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 2015-11-23 |
| Branan Medical Corp. | 1 | 2013-01-30 |
12 more applicants have JXN clearances. See the full list in Caduvo.
Most recent JXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152495 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo Propoxyphene Urine Test | 2015-11-23 | 83 |
| K122752 | Branan Medical Corp. | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | 2013-01-30 | 145 |
| K111363 | Medica Corp. | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | 2011-12-06 | 204 |
| K043303 | Roche Diagnostics Corp. | ONLINE DAT PROPOXYPHENE PLUS | 2005-03-11 | 101 |
| K040445 | ACON Laboratories, Inc. | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE | 2004-05-19 | 89 |
Recalls for JXN devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-04.
Frequently asked questions
What is FDA product code JXN?
JXN is the FDA product code for enzyme immunoassay, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel.
What device class is JXN?
Class II, regulation 21 CFR 862.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXN?
Across 22 cleared submissions the average was 82 days from receipt to decision (median 69).
Which companies have the most JXN clearances?
Syva Co. (4); Abbott Laboratories (2); Roche Diagnostic Systems, Inc. (2); Guangzhou Wondfo Biotech Co., Ltd. (1); Branan Medical Corp. (1).
Have JXN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code JXN
- Run a recall and safety report across every JXN manufacturer
- Watch product code JXN 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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