# K122752: Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corp.
- Decided: Jan 30, 2013 after 145 days
- Product code: JXN (Enzyme Immunoassay, Propoxyphene)
- Device class: 2
- Regulation: 21 CFR 862.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945610 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041685: Acon Multi-Clin Drug Screen Test Device, ACON Laboratories, Inc. (2004) Summary page 2.

## Indications for use
The Fastect®& 11 PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL. The FastectV 11 Drug Screen Dipstick and QuickTox®t Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: THC II -nor-A9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/mI COC Benzoylecgonine 300 ng/ml OPI Morphine 300 ng/ml MET Methamphetamine 500 nglml AMP Amphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml BZO Oxazepam 300 ng/ml BAR Secobarbital 300 ng/ml MTD Methadone 300 nglml TCA Nortriptyline 1000 ng/ml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml OXY Oxycodone 100 rig/mI BUP Buprenorphine 10 ng/mI PPX Propoxyphene 300 ng/ml These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals. These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickToxg Drug Screen Dipeard, Fastecto 11 Drug Screen Dipstick or Fastect® 11 PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical Consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.

Source page: https://510kreport.com/device/K122752
Methodology: https://510kreport.com/methodology