510(k) Report

510(k) · Cleared

Cleared

Verdict-II Propoxyphene

K020787510(k) TraditionalCleared May 2, 200252-day reviewClass II21 CFR 862.3700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtox Diagnostics, Inc. · JXN Enzyme Immunoassay, Propoxyphene

Cleared on May 2, 2002 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.

Decided
May 2, 2002
Review
52 days
Class
Class II
Product code
JXN
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK020787 Verdict-II PropoxypheneMedtox Diagnostics, Inc. · 2002
  2. Descendant · cites it directly · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
  3. Descendant · 2 generations on · 1 of its ownK220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK250741 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
  5. Descendant · 2 generations on · 0 of its ownK221550 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023
  6. Descendant · 2 generations on · 0 of its ownK100023 Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test…Medtox Diagnostics, Inc. · 2010

Most influential descendants

Showing 5 of 5 · See all
  • K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · cites it directly4descendants
  • K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · 2 generations on1descendant
  • K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026 · 3 generations on0descendants
  • K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023 · 2 generations on0descendants
  • K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020787Verdict-II PropoxypheneMedtox Diagnostics, Inc.2002—
+1K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.2009—
+2K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited20231
+3K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2026—
+2K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2023—
+2K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
202320
202610
FIG. 1 — Lineage of K020787, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.20094

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?

  • Of its descendants, K091454 (Medtox Diagnostics, Inc., 2009) has gone furthest, with 4 descendants of its own.

How does its category compare?

All JXN devices

JXN Enzyme Immunoassay, Propoxyphene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXN

1in 2015

2011: 12013: 12015: 1
2007high 1 (2011) · low 0 (2007)2026

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

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXN

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code JXN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—00
20100—10
20111—00
20120—00
20131—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A…

Read the full statement (98 words)

VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale.

VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Medtox Diagnostics, Inc.

22 FDA decisions under this applicant name. See the company

  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
  • K100951Medtox Buprenorphine TestMedtox Diagnostics, Inc. · 2010
  • K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc. · 2010
  • K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
  • K080635MedtoxscanMedtox Diagnostics, Inc. · 20091 recall

Recent decisions in JXN

The JXN category page

  • K152495Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2015
  • K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen DipcardBranan Medical Corp. · 2013
  • K111363PPX Reagent, PPX Calibrators, PPX QC MaterialMedica Corp. · 2011
  • K043303Online Dat Propoxyphene PlusRoche Diagnostics Corp. · 2005
  • K040445Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceACON Laboratories, Inc. · 2004

https://510kreport.com/device/K020787 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020787: Verdict-II Propoxyphene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020787

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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