SYNCHRON SYSTEMS METHAQUALONE REAGENT

K955676 · Beckman Instruments, Inc. · KXS · Mar 4, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955676
• Device Name: SYNCHRON SYSTEMS METHAQUALONE REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: KXS · Clinical Toxicology
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3630
• Device Class: Class 2

Intended Use

The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Device Story

The SYNCHRON Methaqualone Reagent is an enzyme immunoassay test kit used on Beckman SYNCHRON chemistry analyzers. It processes human urine samples to detect Methaqualone and its metabolites. The device operates via a competitive binding principle: drug in the sample competes with drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity is measured by the conversion of NAD to NADH, which is monitored spectrophotometrically by the analyzer. The system automates pipetting, mixing, and reaction timing at a constant temperature. Results are provided as a qualitative screen to healthcare providers to assist in clinical decision-making regarding drug use. The device is intended for use in clinical laboratory settings by trained laboratory personnel.

Clinical Evidence

Performance supported by method comparison, stability, and imprecision studies. Comparison against Emit II (n=103 samples) showed 94% overall agreement, 88% relative sensitivity, and 100% relative specificity. Zero discordant results were observed when compared against GCMS. Within-run imprecision (%CV) ranged from 0.3% to 0.6% across calibrators and controls.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid-stabilized reagent; competitive binding mechanism using G6PDH enzyme label; spectrophotometric detection of NADH conversion; automated chemistry analyzer platform; 60-day on-instrument stability; 7-day calibration frequency.

Indications for Use

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

Regulatory Classification

Identification

A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.

Special Controls

*Classification.* Class II (special controls). A methaqualone 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 Methaqualone Assay (K921013)
• Methaqualone Reagent, Diagnostic Reagents, Inc (K940123)
• Urine Calibrator and Controls, Diagnostic Reagents, Inc. (K935101)

Submission Summary (Full Text)

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

# BECKMAN

MAR - 4 1996

Appendix C
Summary of Safety & Effectiveness
SYNCHRON® Systems Methaqualone Reagent

## 1.0 Submitted By

K. 955676

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 Methaqualone (METQ) Reagent
SYNCHRON Systems DAT Negative Urine Calibrator
SYNCHRON Systems DAT Low Urine Calibrator II
SYNCHRON Systems DAT High Urine Calibrator II
SYNCHRON Systems DAT Low Urine Control II
SYNCHRON Systems DAT High Urine Control II

### 3.2 Classification Names

Methaqualone test system (21 CFR 862.3630)
Toxicology calibrator (21 CFR 862.3200)
Toxicology control (21 CFR 862.3280)

## 4.0 Predicate Device(s)

Emit II Methaqualone Assay, Syva Company, K921013
Methaqualone Reagent, Diagnostic Reagents, Inc, K940123
Urine Calibrator and Controls, Diagnostic Reagents, Inc., K935101

## 5.0 Description

The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone 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 Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of

file: metq510k.sse
Beckman Instruments, Inc.
twx. 910-592-1260 • •• 96-784-1

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Beckman Instruments, Inc. Section 510(k) Notification
SYNCHRON® Systems Methaqualone Reagent

Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

## 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 Methaqualone Reagent | Emit II Methaqualone Reagent |
| --- | --- |
| Similarities | |
| Homogeneous enzyme immunoassay intended for the qualitative analysis of Methaqualone 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 Methaqualone Reagent to the Emit II Reagent.

Relative Sensitivity and Specificity Study Results
CX Methaqualone Reagent vs Emit II

| Overall Agreement | 94% |
| --- | --- |
| Relative Sensitivity | 88% |
| Relative Specificity | 100% |
| Number of Disconcordant w/ Emit II | 6 |
| Number of Disconcordant w/ GCMS | 0 |
| Total Number of Samples | 103 |

file: metq510k.sse

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Beckman Instruments, Inc. Section 510(k) Notification
SYNCHRON® Systems Methaqualone Reagent

SYNCHRON Methaqualone Stability Study Results

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

Estimated Within-Run Imprecision
SYNCHRON Methaqualone Reagent

| Material | Mean (mA/min) | SD (mA/min) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| Negative Calibrator | 117 | 0.8 | 0.6 | 20 |
| Control 1 (200 ng/mL) | 216 | 1.1 | 0.5 | 20 |
| Low Calibrator (300 ng/mL) | 243 | 0.9 | 0.4 | 20 |
| Control 2 (375 ng/mL) | 265 | 1.0 | 0.4 | 20 |
| High Calibrator (1000 ng/mL) | 290 | 0.9 | 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.

file: metq510k.sse