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 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 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.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Shelf-life	24 months
Precision (measured as %CV for controls at different concentrations)	THC Control 1 (10 ng/mL): 0.53% THC Control 2 (40 ng/mL): 0.49%

Study Details:

Sample Size used for the test set and data provenance:
- Imprecision Study: 20 results for each control (Negative Calibrator, THC Control 1 (10 ng/mL), Low Calibrator (20 ng/mL), THC Control 2 (40 ng/mL), High Calibrator (50 ng/mL)).
- Data Provenance: Not explicitly stated, but the study was conducted by Beckman Instruments, Inc. for their SYNCHRON® Systems controls, suggesting it's internal prospective data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material and the "ground truth" for its performance is inherent in its formulation and expected behavior, not established by expert interpretation.
Adjudication method for the test set:
- Not applicable. The performance is based on analytical precision and stability measurements, not expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a quality control material for an immunoassay system, not an AI diagnostic tool that human readers would use or be assisted by.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a quality control material, not an algorithm. Its performance is evaluated through analytical studies.
The type of ground truth used:
- For the imprecision study, the "ground truth" for the expected values of the controls and calibrators would be established during their manufacturing and formulation. The study measures the device's ability to consistently reproduce those expected values within acceptable limits.
- For the stability study, the "ground truth" is the initial performance of the controls at the time of manufacture, and the study assesses how long they maintain that performance.
The sample size for the training set:
- Not applicable. This device is a quality control material; there is no "training set" in the context of machine learning. The controls are manufactured to specific concentrations.
How the ground truth for the training set was established:
- Not applicable. As there's no training set, there's no ground truth established for it. The ground truth for the performance studies is based on the known, manufactured concentrations and stability profiles of the control materials themselves.

Summary

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APR 1 7 1997

Summary of Safety & Effectiveness SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls

1.0 Submitted By:

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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)

Predicate Device(s): 4.0

4 Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI), K932113

5.0 Description:

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Cannabinoid reagents and controls previously SYNCHRON® Systems 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:

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Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRONSystems 10 and40 ng/mL THCUrine Controls	Liquid, ready-to-use, human urinematrix control.	Same as DRI
	Intended use (for monitoring thequality control of THC enzymeimmunoassays)	Same as DRI
	Manufacturing process andqualification	Same as DRI
DIFFERENCES
SYNCHRONSystems 10 and40 ng/mL THCUrine Controls	Labeling	Controls are labeled atDRI using Beckmanlabels and insert
	Limitations for use	Controls are to be usedonly with SYNCHRONSystems andSYNCHRONCannabinoid 20 ng(THC2) Reagent
	Concentration of THC in the 10ng/mL control	The concentration levelof THC in the lowercontrol is 10 ng/mL

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Summary of Performance Data: 8.0

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 മീ Cannabinoid Urine Controls.

Stability Study Results

Reagent	Product Claim
SYNCHRON® Systems10 ng/mL and 40ng/mLTHC Urine Controls	24 month shelf-life

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Precision Study Results

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

SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls

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.

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.