The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is 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, and CX7 DELTA Systems.

Device Description

The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.

AI/ML Overview

Acceptance Criteria and Device Performance for BECKMAN SYNCHRON® Systems Cannabinoid 20 ng Reagent

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "equivalence" to a predicate device through various performance studies. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that supports substantial equivalence.

Performance Metric	Inferred Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (SYNCHRON Cannabinoid 20 ng Reagent)
Overall Agreement	High agreement with predicate (Emit II Cannabinoid Reagent)	99%
Relative Sensitivity	High sensitivity relative to predicate	99%
Relative Specificity	High specificity relative to predicate	100%
Number of Discordant with Emit II	Low number of discordant results (indicating strong agreement)	1
Shelf-life (unopened)	At least 12 months (matching or exceeding predicate)	12 months
On-Instrument Stability	At least 60 days (matching or exceeding predicate)	60 days
Calibration Frequency	7 days	7 days
Within-Run Imprecision (%CV)	Low variability (e.g., < 5% or similar to predicate)	0.3% for Negative Calibrator, Control 1, Low Calibrator, Control 2, High Calibrator

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: 136 samples
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document refers to "method comparison, stability, and imprecision experiments" and "results obtained from the SYNCHRON Systems Cannabinoid 20 ng Reagent to the Emit II Reagent." This suggests the samples were likely collected for the purpose of comparing the new device to the predicate. The absence of specific patient demographics or collection details prevents a definitive classification of retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study primarily relies on the Emit II Cannabinoid Reagent as the comparative standard, implying its results served as the reference for determining relative sensitivity and specificity.

4. Adjudication Method for Test Set

Adjudication Method: Not specified. The comparison is stated as "SYNCHRON Cannabinoid 20 ng Reagent vs Emit II," suggesting a direct comparison without an explicit adjudication process beyond the Emit II result itself. Discordant results are noted (1), but the method for resolving or adjudicating this discrepancy is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focuses on the performance of a diagnostic reagent rather than the interpretation of medical images or data by multiple human readers.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: Yes, a standalone performance study was done. The reported performance metrics (Overall Agreement, Relative Sensitivity, Relative Specificity, Imprecision) are for the SYNCHRON Cannabinoid 20 ng Reagent operating independently. The "human-in-the-loop" aspect for this type of device would primarily involve sample collection and proper operation of the SYNCHRON analyzer, rather than interpretation of results that influence the device's fundamental performance.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for evaluating the SYNCHRON device's performance was established using a predicate device's results, specifically the Emit II Cannabinoid 20 ng Assay. This is referred to as "Relative Sensitivity" and "Relative Specificity" against the predicate.

8. Sample Size for Training Set

Sample Size for Training Set: Not explicitly stated. The document describes the device as a "reagent test kit" for an "enzyme immunoassay reagent." Such immunoassays typically do not involve a "training set" in the context of machine learning algorithms. The development process would involve formulation, optimization, and validation using various samples, but these are not typically referred to as a "training set" in this context. The study focuses on validation against a predicate using a specified test set.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: As stated above, the concept of a "training set" with established ground truth, as understood in machine learning, does not directly apply to this type of immunoassay reagent. The "ground truth" used for initial development and optimization would have been based on known concentrations of cannabinoids in spiked samples and/or comparison to established reference methods or previously validated assays, similar to how the product was later validated against the Emit II predicate. The document does not provide details on this development phase.

Summary

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BECKMAN

Appendix C Summary of Safety & Effectiveness SYNCHRON® Systems Cannabinoid 20 ng Reagent

APR - 3

1.0 Submitted By

K955677

Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea, California 92621 Telephone: (714) 993-8916 FAX: (714) 961-4457

2.0 Date Submitted

15 December 1995

3.0 Device Name(s)

3.1 Proprietary Names

SYNCHRON Systems Cannabinoids 20 ng (THC2) Reagent SYNCHRON Systems DAT Negative Urine Calibrator SYNCHRON Systems 20 ng/mL THC Urine Calibrator SYNCHRON Systems 50 ng/mL THC Urine Calibrator SYNCHRON Systems 0 ng/mL THC Urine Control SYNCHRON Systems 50 ng/mL THC Urine Control

3.2 Classification Names

Cannabinoid test system (21 CFR 862.3870)

4.0 Predicate Device(s)

Emit II Cannabinoid 20 ng Assay, Syva Company, K940158 Cannabinoid Reagent, Diagnostic Reagents, Inc. K943998 THC Urine Calibrators and Controls, Diagnostic Reagents, Inc., K944701

5.0 Description

6.0 Intended Use

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7.0 Comparison to Predicate(s)

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

SYNCHRON Cannabinoid Reagent	Emit II Cannabinoid Reagent
Similarities
Homogeneous enzyme immunoassayintended for the qualitative analysis ofcannabinoids in human urine	Same
Method based on competition betweendrug in the sample and drug labeled withthe enzyme G6PDH; enzyme activitymeasured as NAD is converted to NADH	Same
Reagent designed for chemistry analyzerswhich maintain constant reactiontemperature, use automated pipetting,measure enzyme rates, mix, andaccurately time reactions	Same
Reagent provides preliminary analyticaltest for screening purposes	Same
Differences
SYNCHRON reagent is liquid stabilizedand requires no preparation	Emit II reagent is lyophilized and requiresreconstitution
SYNCHRON reagent is intended forqualitative determinations only	Emit II reagent has a specializedapplication for semi-quantitativedetermination of drug concentration
SYNCHRON reagent is stable for 60 daysonce opened, when stored properly	Emit II reagent is stable for 12 weeks onceopened, if handled as directed

8.0 Summary of Performance Data

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the SYNCHRON Systems Cannabinoid 20 ng Reagent to the Emit II Reagent.

SYNCHRON Cannabinoid 20 ng Reagent vs Emit II
Overall Agreement	99%
Relative Sensitivity	99%
Relative Specificity	100%
Number of Disconcordant w/ Emit II	1
Total Number of Samples	136

Relative Sensitivity and Specificity Study Results

SYNCHRON Cannabinoid 20 ng Reagent Stability Study Results

Product Claim	510(k) Summary
Shelf-life	12 months unopened
On-Instrument Stability	60 days
Calibration Frequency	7 days

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Material	Mean(mA/min)	SD(mA/min)	%CV	Number ofResults
Negative Calibrator	245	0.8	0.3	20
Control 1 (0 ng/mL)	245	0.8	0.3	20
Low Calibrator (20 ng/mL)	274	0.9	0.3	20
Control 2 (50 ng/mL)	318	1.0	0.3	20
High Calibrator (50 ng/mL)	318	1.1	0.3	20

Estimated Within-Run Imprecision SYNCHRON Cannabinoid 20 ng Reagent

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

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).