510(k) · Cleared
ClearedSynchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Cleared on Jun 3, 1997 as substantially equivalent to K923783 (Diagnostic Reagents, Inc., 1993) after a 39-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 3, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- DMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923783 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923783 Ethyl Alcohol AssayDiagnostic Reagents, Inc. · 1993
- This deviceK971506 Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol…Beckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923783 | Ethyl Alcohol Assay | Diagnostic Reagents, Inc. | 1993 | — |
| 0 (this device) | K971506 | Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator | 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 DMT? 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 |
|---|---|---|---|
| * | K923783 | Ethyl Alcohol AssaySummary page 1…Names Alcohol Test system (21 CFR 862.3040) Predicate Device(s): SYNCHRON Predicate Predicate Company Docket Reagent Number SYNCHRON DCL Ethanol Diagnostic Chemicals | K923783 Systems Alcohol Assay Limited (DCL), (ALC) Reagent Charlottetown, PEI, KS24733 Canada 10_sse, 04/97 - Beckman I… | 1993 |
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.
- 1 other device also cites its predicate K923783.
How does its category compare?
All DMT devicesDMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DMT
FDA has decided no DMT device since 2007.
Median 510(k) review, days · DMT
Too few DMT 510(k)s in any year since 2007 to give a median.
Recalls per year · DMT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DMT
2in 2011
MAUDE reports naming product code DMT, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
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/K971506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971506: Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971506
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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