SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc. · LAS · Apr 17, 1997 · Clinical Toxicology
Device Facts
| Record ID | K971210 |
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| Device Name | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS |
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| Applicant | Beckman Instruments, Inc. |
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| Product Code | LAS · Clinical Toxicology |
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| Decision Date | Apr 17, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 862.3280 |
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| Device Class | Class 1 |
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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.
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.
Indications for Use
Indicated for use as quality control material in clinical laboratories to monitor the performance of cannabinoid (THC) enzyme immunoassays on SYNCHRON Systems.
Regulatory Classification
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)
Related Devices
- K021449 — CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS · Lin-Zhi International, Inc. · Jun 18, 2002
- K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS · Roche Diagnostics Corp. · Dec 2, 2003
- K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK · Bio-Rad Laboratories, Inc. · Mar 27, 2012
- K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE · Consolidated Technologies, Inc. · Jul 14, 1999
- K021411 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 · Bio-Rad · May 29, 2002
Submission Summary (Full Text)
{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
