510(k) · Cleared
ClearedAccusign MTD, Biosign MTD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · DJR Enzyme Immunoassay, Methadone
Cleared on Apr 15, 1999 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 15, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK991080 Accusign MTD, Biosign MTDPrinceton BioMeditech Corp. · 1999
- Descendant · cites it directly · 2 of its ownK012595 Acon MTD One Step Methadone Test Strip and Test DeviceACON Laboratories, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
- Descendant · 2 generations on · 0 of its ownK052197 First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K012595Acon MTD One Step Methadone Test Strip and Test DeviceACON Laboratories, Inc. · 2001 · cites it directly2descendants
- K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010 · 2 generations on0descendants
- K052197First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991080 | Accusign MTD, Biosign MTD | Princeton BioMeditech Corp. | 1999 | — |
| +1 | K012595 | Acon MTD One Step Methadone Test Strip and Test Device | ACON Laboratories, Inc. | 2001 | — |
| +2 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
| +2 | K052197 | First Sign Drug of Abuse Urine Screening Test | W.H.P.M., Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
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 DJR? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012595 | Acon MTD One Step Methadone Test Strip and Test Device | 2001 | 2 |
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, K012595 (ACON Laboratories, Inc., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the qualitative detection of methadone in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991080: Accusign MTD, Biosign MTD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991080
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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