510(k) · Cleared
ClearedSynchron Systems Methadone Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Sep 22, 1997 as substantially equivalent to K944074 (Beckman Instruments, Inc., 1994) after a 35-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 22, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944074 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944074 CX (TM) Methadone (Metd) Reagent for Synchron CX SystBeckman Instruments, Inc. · 1994
- This deviceK973069 Synchron Systems Methadone ReagentBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944074 | CX (TM) Methadone (Metd) Reagent for Synchron CX Syst | Beckman Instruments, Inc. | 1994 | — |
| 0 (this device) | K973069 | Synchron Systems Methadone Reagent | Beckman Instruments, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K944074 | CX (TM) Methadone (Metd) Reagent for Synchron CX Syst Our OCR of the scanned summary read K974074, FDA’s number for Infusion Dynamics Power Infuser (Infusion Dynamics, Inc.), decided Feb 17, 1998, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SYNCHRON Systems Methadone”. | 1994 |
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?
- Its one ancestor has no recall.
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 Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.
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/K973069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973069: Synchron Systems Methadone Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973069
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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