510(k) · Cleared
ClearedOnline Dat Propoxyphene Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JXN Enzyme Immunoassay, Propoxyphene
Cleared on Mar 11, 2005 as substantially equivalent to K983700 (Roche Diagnostic Systems, Inc., 1998) after a 101-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 11, 2005
- Review
- 101 days
- Class
- Class II
- Product code
- JXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945195 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K983700 | Modification to Abuscreen Online for PropoxypheneSummary page 1…e: Enzyme immunoassay, Propoxyphene 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Propox yphene assay (K9 83 700). Continued on next page… | 1998 |
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 11 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 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.
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?
Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on Roche/Hitachi automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or…
Read the full statement (134 words)
Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on Roche/Hitachi automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse and do not measure a level of toxicity.
Propoxyphene Plus 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 used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043303: Online Dat Propoxyphene Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043303
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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