← Product Code [LAS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS) · K971210 # SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210) _Beckman Instruments, Inc. · LAS · Apr 17, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K971210 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [LAS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS.md) - **Decision Date:** Apr 17, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3280 - **Device Class:** Class 1 - **Review Panel:** Clinical Toxicology ## Indications for Use 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 SYNCHRON CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, CX7 DELTA Systems and LX™20 Systems. ## Device Story SYNCHRON Systems 10 ng/mL and 40 ng/mL THC Urine Controls are ready-to-use, human urine-based liquid controls. Used in clinical laboratories to monitor the quality control of THC enzyme immunoassays. Controls are processed on SYNCHRON analyzer systems (e.g., CX4, CX5, CX7, LX20) alongside patient samples. By providing known concentrations of THC, the controls allow laboratory personnel to verify assay performance and ensure accurate clinical testing results. The device serves as a standard reference to validate the analytical process. ## Clinical Evidence Bench testing only. Stability studies support a 24-month shelf-life. Precision studies conducted with 20 replicates per material showed low imprecision (%CV 0.36% to 0.53%) across negative, low, and high calibrators and the 10 ng/mL and 40 ng/mL THC controls. ## Technological Characteristics Human urine-based liquid control; ready-to-use. Designed for use with SYNCHRON clinical chemistry analyzers. Storage requirements: +2°C to +8°C. ## Regulatory Identification A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials. ## Predicate Devices - Δ9 Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI) ([K932113](/device/K932113.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls Summary of Safety & Effectiveness Summary of Safety & Effectiveness SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls 1.0 Submitted By: K971210 Frank Marte, R.A.C. Regulatory Affairs Staff Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-4406 FAX: (714) 961-4457 2.0 Date Submitted: 31 March 1997 3.0 Device Name(s): 3.1 Proprietary Names SYNCHRON® Systems 10 ng/mL THC Urine Control SYNCHRON® Systems 40 ng/mL THC Urine Control 3.2 Classification Names Clinical Toxicology Control Material (21 CFR § 862.3280) 4.0 Predicate Device(s): $\Delta^9$ Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI), K932113 5.0 Description: The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls designed to be used as part of a laboratory total quality management program to ensure proper THC assay performance. These controls complement the current panel of file: thc510k.sse, 04/01/97 {1} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls Summary of Safety & Effectiveness SYNCHRON® Systems Cannabinoid reagents and controls previously cleared by the FDA. The kit consists of 1 x 5.0 mL bottle and must be stored at +2°C to +8°C. ## 6.0 Intended Use: 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 SYNCHRON CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, CX7 DELTA Systems and LX™20 Systems. file: thc510k.sse, 04/01/97 {2} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls Summary of Safety & Effectiveness # 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | Reagent | Aspect/Characteristic | Comments | | --- | --- | --- | | SIMILARITIES | | | | SYNCHRON Systems 10 and 40 ng/mL THC Urine Controls | Liquid, ready-to-use, human urine matrix control. | Same as DRI | | | Intended use (for monitoring the quality control of THC enzyme immunoassays) | Same as DRI | | | Manufacturing process and qualification | Same as DRI | | DIFFERENCES | | | | SYNCHRON Systems 10 and 40 ng/mL THC Urine Controls | Labeling | Controls are labeled at DRI using Beckman labels and insert | | | Limitations for use | Controls are to be used only with SYNCHRON Systems and SYNCHRON Cannabinoid 20 ng (THC2) Reagent | | | Concentration of THC in the 10 ng/mL control | The concentration level of THC in the lower control is 10 ng/mL | file:thc510k.sse {3} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls Summary of Safety & Effectiveness ## 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to a control test system already in commercial distribution. Equivalence is demonstrated through stability and imprecision studies that relate results obtained from the SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls to the DRI $\Delta^9$ Cannabinoid Urine Controls. ### Stability Study Results | Reagent | Product Claim | | --- | --- | | SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls | 24 month shelf-life | file: thc510k.sse, 04/01/97 {4} Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls Summary of Safety & Effectiveness ## Precision Study Results SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls | Material | Mean (mA/min) | SD (mA/min) | %CV | Number of Results | | --- | --- | --- | --- | --- | | Negative Calibrator | 262.40 | 0.95 | 0.36 | 20 | | THC Control 1 (10 ng/mL) | 272.36 | 1.45 | 0.53 | 20 | | Low Calibrator (20 ng/mL) | 283.32 | 1.30 | 0.46 | 20 | | THC Control 2 (40 ng/mL) | 306.98 | 1.52 | 0.49 | 20 | | High Calibrator (50 ng/mL) | 319.38 | 1.32 | 0.41 | 20 | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. file: thc510k.sse --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K971210](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K971210) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com