510(k) · Cleared
ClearedAcon MTD One Step Methadone Test Strip and Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Oct 15, 2001 as substantially equivalent to K991080 (Princeton BioMeditech Corp., 1999) after a 66-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Oct 15, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991080 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991080 Accusign MTD, Biosign MTDPrinceton BioMeditech Corp. · 1999
- This deviceK012595 Acon MTD One Step Methadone Test Strip and Test DeviceACON Laboratories, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK092048 One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
- Descendant · cites it directly · 0 of its ownK052197 First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991080 | Accusign MTD, Biosign MTD | Princeton BioMeditech Corp. | 1999 | — |
| 0 (this device) | K012595 | Acon MTD One Step Methadone Test Strip and Test Device | ACON Laboratories, Inc. | 2001 | — |
| +1 | K092048 | One Step Eddp (Methadone Metabolite) Test Strip | Biosite Incorporated | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K991080 | Accusign MTD, Biosign MTDSummary page 2…ting that proper volume of specimen has been added and membrane wicking has occurred. Predicate Device: LifeSign Status DS™ MTD One-Step Methadone Test 510(k) Number: K991080 Comparison to a Predicate Device: A comparison of the features of the ACON MTD One Step Methadone Test Strip and ACON MTD One S… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K092048 (Biosite Incorporated, 2010) has gone furthest, with 0 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?
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of Methadone in human urine at a cut-off concentration of 300 ng/mL. They are intended for healthcare professionals and professional point-of-care use.
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/K012595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012595: Acon MTD One Step Methadone Test Strip and Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012595
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026