JXN · Enzyme Immunoassay, Propoxyphene
Clinical Toxicology · 21 CFR 862.3700 · Class 2
Overview
| Product Code | JXN |
|---|---|
| Device Name | Enzyme Immunoassay, Propoxyphene |
| Regulation | 21 CFR 862.3700 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | Nov 23, 2015 | SESE |
| K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | Branan Medical Corp. | Jan 30, 2013 | SESE |
| K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | Medica Corp. | Dec 6, 2011 | SESE |
| K043303 | ONLINE DAT PROPOXYPHENE PLUS | Roche Diagnostics Corp. | Mar 11, 2005 | SESE |
| K040445 | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE | ACON Laboratories, Inc. | May 19, 2004 | SESE |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | American Bio Medica Corp. | May 22, 2003 | SESE |
| K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | Lin-Zhi International, Inc. | Jan 21, 2003 | SESE |
| K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | Alfa Scientific Designs, Inc. | Nov 29, 2002 | SESE |
| K020787 | VERDICT-II PROPOXYPHENE | Medtox Diagnostics, Inc. | May 2, 2002 | SESE |
| K013100 | PROPOXYPHENE | Abbott Laboratories | Mar 20, 2002 | SESE |
| K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 | Syva Co., Dade Behring, Inc. | May 10, 2001 | SESE |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | Syva Co. | Feb 1, 2000 | SESE |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Roche Diagnostic Systems, Inc. | Dec 11, 1998 | SESE |
| K955675 | SYNCHRON SYSTEMS PROPOXYPHENE REAGENT | Beckman Instruments, Inc. | Feb 9, 1996 | SESE |
| K951133 | CEDIA DAU PROPOXYPHENE ASSAY | Microgenics Corp. | May 2, 1995 | SESE |
| K944372 | STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA | Solarcare, Inc. | Feb 8, 1995 | SESE |
| K945195 | ABUSCREEN ONLINE PROPOXPHENE | Roche Diagnostic Systems, Inc. | Dec 9, 1994 | SESE |
| K943414 | PROPOXPHENE EIA TEST | Diagnostic Reagents, Inc. | Sep 9, 1994 | SESE |
| K923873 | SYVA EMIT II PROPOXYPHENE ASSAY | Syva Co. | Nov 2, 1992 | SESE |
| K912365 | TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS | Abbott Laboratories | Aug 16, 1991 | SESE |
Top Applicants
- Syva Co. — 4 clearances
- Abbott Laboratories — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- ACON Laboratories, Inc. — 1 clearance
- Alfa Scientific Designs, Inc. — 1 clearance
