510(k) · Cleared
ClearedSynchron Systems 10 NG/ML & 40 NG/ML THC Urine Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · LAS Drug Specific Control Materials
Cleared on Apr 17, 1997 as substantially equivalent to K932113 (Diagnostic Reagents, Inc., 1993) after a 15-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 17, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932113 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK932113 Cannabinoid Urine ControlsDiagnostic Reagents, Inc. · 1993
- This deviceK971210 Synchron Systems 10 NG/ML & 40 NG/ML THC Urine ControlsBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932113 | Cannabinoid Urine Controls | Diagnostic Reagents, Inc. | 1993 | — |
| 0 (this device) | K971210 | Synchron Systems 10 NG/ML & 40 NG/ML THC Urine Controls | 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 LAS? 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 |
|---|---|---|---|
| * | K932113 | Cannabinoid Urine ControlsSummary page 1…3.2 Classification Names Clinical Toxicology Control Material (21 CFR § 862.3280) Predicate Device(s): A® Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI), K932113 Description: The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls… | 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 K932113.
How does its category compare?
All LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LAS
Too few LAS 510(k)s in any year since 2007 to give a median.
Recalls per year · LAS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAS
No MAUDE report names LAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 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 10 ng/mL and 40 ng/mL THC Urine Controls, in conjunction with the SYNCHRON Cannabinoid 20 ng (THC2) Reagent, are intended for use on SYNCHRON Systems for monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory. These controls are designed for use with the family of SYNCHRON Systems which include analyzers such as the SXNCHRON CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, CX7 DELTA Systems and LX™20 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/K971210 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971210: Synchron Systems 10 NG/ML & 40 NG/ML THC Urine Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971210
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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