Enzyme Immunoassay, Propoxyphene
FDA product code JXN · Class II (moderate risk) · 21 CFR 862.3700 · Clinical Toxicology
22510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Syva Co. 4
- Abbott Laboratories 2
- Roche Diagnostic Systems, Inc. 2
- Guangzhou Wondfo Biotech Co., Ltd. 1
- Branan Medical Corp. 1
- Medica Corp. 1
- Roche Diagnostics Corp. 1
- ACON Laboratories, Inc. 1
- American Bio Medica Corp. 1
- Lin-Zhi International, Inc. 1
- Alfa Scientific Designs, Inc. 1
- Medtox Diagnostics, Inc. 1
- Syva Co., Dade Behring, Inc. 1
- Beckman Instruments, Inc. 1
- Microgenics Corp. 1
- Solarcare, Inc. 1
- Diagnostic Reagents, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine TestJXN · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/23/2015SE |
| K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…JXN · Traditional | Branan Medical Corp. | 01/30/2013SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | Medica Corp. | 12/06/2011SE |
| K043303 | Online Dat Propoxyphene PlusJXN · Traditional | Roche Diagnostics Corp. | 03/11/2005SE |
| K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceJXN · Traditional | ACON Laboratories, Inc. | 05/19/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | American Bio Medica Corp. | 05/22/2003SE |
| K023795 | Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)JXN · Traditional | Lin-Zhi International, Inc. | 01/21/2003SE |
| K022915 | Instant-View Propoxyphene (PPX) Urine TestJXN · Traditional | Alfa Scientific Designs, Inc. | 11/29/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | Medtox Diagnostics, Inc. | 05/02/2002SE |
| K013100 | PropoxypheneJXN · Traditional | Abbott Laboratories | 03/20/2002SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | Syva Co. | 02/01/2000SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | Roche Diagnostic Systems, Inc. | 12/11/1998SE |
| K955675 | Synchron Systems Propoxyphene ReagentJXN · Traditional | Beckman Instruments, Inc. | 02/09/1996SE |
| K951133 | Cedia Dau Propoxyphene AssayJXN · Traditional | Microgenics Corp. | 05/02/1995SE |
| K944372 | STC Diagnostic Auto-Lyte Propoxyphene EiaJXN · Traditional | Solarcare, Inc. | 02/08/1995SE |
| K945195 | Abuscreen Online PropoxpheneJXN · Traditional | Roche Diagnostic Systems, Inc. | 12/09/1994SE |
| K943414 | Propoxphene Eia TestJXN · Traditional | Diagnostic Reagents, Inc. | 09/09/1994SE |
| K923873 | Syva Emit II Propoxyphene AssayJXN · Traditional | Syva Co. | 11/02/1992SE |
| K912365 | Tdx(R)/Tdxflx(Tm) & Adx(R) Propoxphene AssaysJXN · Traditional | Abbott Laboratories | 08/16/1991SE |
| K874200 | Revised Labeling for Syva Propoxyphene AssaysJXN · Traditional | Syva Co. | 10/28/1987SE |
| K850920 | Emit D.A.U. Propoxyphene AssayJXN · Traditional | Syva Co. | 04/02/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3113-2011 | DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue…Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP)… | Express Diagnostics Int'l., Inc. | 10/04/2010Terminated |
| Z-1874-2008 | VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test…Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Sun Biomedical Laboratories, Inc. | 05/28/2008Terminated |