510(k) · Cleared
ClearedModification to Abuscreen Online for Propoxyphene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · JXN Enzyme Immunoassay, Propoxyphene
Cleared on Dec 11, 1998 as substantially equivalent to K945195 (Roche Diagnostic Systems, Inc., 1994) after a 51-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Dec 11, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- JXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945195 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK945195 Abuscreen Online PropoxpheneRoche Diagnostic Systems, Inc. · 1994
- This deviceK983700 Modification to Abuscreen Online for PropoxypheneRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK043303 Online Dat Propoxyphene PlusRoche Diagnostics Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K043303Online Dat Propoxyphene PlusRoche Diagnostics Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945195 | Abuscreen Online Propoxphene | Roche Diagnostic Systems, Inc. | 1994 | — |
| 0 (this device) | K983700 | Modification to Abuscreen Online for Propoxyphene | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K043303 | Online Dat Propoxyphene Plus | Roche Diagnostics Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K945195 | Abuscreen Online PropoxpheneSummary page 2…gnostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Abuscreen ONLINE for K945195 12/9/94 Propoxyphene Propoxyphene 027 Roche Diagnostic Systems, Inc. Abuscreen ONLINE® Propoxyphene Somerville.… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043303 | Online Dat Propoxyphene Plus | 2005 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K043303 (Roche Diagnostics Corp., 2005) has gone furthest, with 0 descendants of its own.
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?
Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the
qualitative and semiquantitative detection of propoxyphene and its metabolites in
human urine on automated clinical chemistry analyzers at a cutoff concentration of
300 ng/mL. Semiquantitative 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983700: Modification to Abuscreen Online for Propoxyphene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983700
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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