SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT

K955677 · Beckman Instruments, Inc. · LDJ · Apr 3, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955677
• Device Name: SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

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 Story

The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay test kit for use on Beckman SYNCHRON chemistry analyzers. It detects cannabinoids in human urine via competitive binding between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH). Enzyme activity is measured by the conversion of NAD to NADH, which is monitored spectrophotometrically. The device is used in clinical laboratory settings by trained personnel to provide preliminary screening results. The output is a qualitative determination of cannabinoid presence, which assists healthcare providers in identifying potential drug use. The liquid-stabilized reagent requires no preparation and is designed for automated processing on SYNCHRON systems.

Clinical Evidence

Bench testing only. Method comparison study of 136 urine samples against the Emit II Cannabinoid Reagent demonstrated 99% overall agreement, 99% relative sensitivity, and 100% relative specificity. Imprecision studies (n=20 per material) showed %CV of 0.3% across negative, low, and high calibrator/control levels. Stability studies confirmed 12-month unopened shelf-life and 60-day on-instrument stability.

Technological Characteristics

Homogeneous enzyme immunoassay; competitive binding principle using G6PDH enzyme label; spectrophotometric measurement of NAD to NADH conversion. Liquid-stabilized reagent; automated pipetting and reaction timing on SYNCHRON chemistry analyzers. Constant reaction temperature. 60-day on-instrument stability.

Indications for Use

Indicated for the qualitative screening of cannabinoids and their metabolites in human urine samples to detect drug presence.

Regulatory Classification

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 include delta-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.

Special Controls

*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).

Predicate Devices

• Emit II Cannabinoid 20 ng Assay (K940158)
• Cannabinoid Reagent (K943998)
• THC Urine Calibrators and Controls (K944701)

Submission Summary (Full Text)

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200 South Kraemer Boulevard, Box 8000 Brea CA 92621 8000 • [phone]
26

# BECKMAN

Appendix C

Summary of Safety & Effectiveness

SYNCHRON® Systems Cannabinoid 20 ng Reagent

APR - 3 1995

K955677

## 1.0 Submitted By

Sheri Hall

Manager, Product Submissions

Beckman Instruments, Inc.

200 S. Kraemer Blvd. W-337

Brea, California 92621

Telephone: [phone]

FAX: [phone]

## 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

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.

## 6.0 Intended Use

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.

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Beckman Instruments, Inc.

twx: 910-592-1260 • telex 06-78413

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Beckman Instruments, Inc. Section 510(k) Notification
SYNCHRON® Systems Cannabinoid 20 ng Reagent

# 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 immunoassay intended for the qualitative analysis of cannabinoids in human urine | Same |
| Method based on competition between drug in the sample and drug labeled with the enzyme G6PDH; enzyme activity measured as NAD is converted to NADH | Same |
| Reagent designed for chemistry analyzers which maintain constant reaction temperature, use automated pipetting, measure enzyme rates, mix, and accurately time reactions | Same |
| Reagent provides preliminary analytical test for screening purposes | Same |
| Differences | |
| SYNCHRON reagent is liquid stabilized and requires no preparation | Emit II reagent is lyophilized and requires reconstitution |
| SYNCHRON reagent is intended for qualitative determinations only | Emit II reagent has a specialized application for semi-quantitative determination of drug concentration |
| SYNCHRON reagent is stable for 60 days once opened, when stored properly | Emit II reagent is stable for 12 weeks once opened, 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.

Relative Sensitivity and Specificity Study Results
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 |

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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Beckman Instruments, Inc. Section 510(k) Notification
SYNCHRON® Systems Cannabinoid 20 ng Reagent

Estimated Within-Run Imprecision
SYNCHRON Cannabinoid 20 ng Reagent

| Material | Mean (mA/min) | SD (mA/min) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| 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 |

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.

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