510(k) · Cleared
ClearedFastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corp. · JXN Enzyme Immunoassay, Propoxyphene
Cleared on Jan 30, 2013 as substantially equivalent to K041685 (ACON Laboratories, Inc., 2004) after a 145-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jan 30, 2013
- Review
- 145 days
- Class
- Class II
- Product code
- JXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945610 (1995). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 2 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 1 generation backK041685 Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004
- This deviceK122752 Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen…Branan Medical Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −2 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −1 | K041685 | Acon Multi-Clin Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
| 0 (this device) | K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox… | Branan Medical Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041685 | Acon Multi-Clin Drug Screen Test DeviceSummary page 2…obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis. Substantially Equivalent Devices K041685 - ACON MULTI-CLIN Drug Screen Test Device Device Description The Fastect® 11 Drug Screen Dipstick with Propoxyphene and… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All JXN devicesJXN Enzyme Immunoassay, Propoxyphene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JXN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JXN
Too few JXN 510(k)s in any year since 2007 to give a median.
Recalls per year · JXN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXN
1in 2024
MAUDE reports naming product code JXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (225 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122752: Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122752
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026