510(k) · Cleared
ClearedPropoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · JXN Enzyme Immunoassay, Propoxyphene
Cleared on Jan 21, 2003 as substantially equivalent to K943414 (Diagnostic Reagents, Inc., 1994) after a 69-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jan 21, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- JXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943414 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK943414 Propoxphene Eia TestDiagnostic Reagents, Inc. · 1994
- This deviceK023795 Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121…Lin-Zhi International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943414 | Propoxphene Eia Test | Diagnostic Reagents, Inc. | 1994 | — |
| 0 (this device) | K023795 | Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000… | Lin-Zhi International, Inc. | 2003 | — |
| +1 | K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K943414 | Propoxphene Eia TestSummary page 1…nc. ’ Propoxyphene Enzyme Immunoassay is substantially equivalent to the Propoxyphene Enzyme Immunoassay (By DRIlMicrogenics Corp.), cleared under premarket notification K9434 14. LZI’s Propoxyphene Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, devi… | 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 |
|---|---|---|---|
| K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | 2004 | 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, K033885 (Lin-Zhi International, Inc., 2004) 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?
The Propoxyphene Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of propoxyphene in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Propoxyphene Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to…
Read the full statement (101 words)
The Propoxyphene Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of propoxyphene in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Propoxyphene Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any dmg-of-abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023795: Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023795
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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