SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR

K971506 · Beckman Instruments, Inc. · DMT · Jun 3, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971506
• Device Name: SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
• Applicant: Beckman Instruments, Inc.
• Product Code: DMT · Clinical Toxicology
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Indications for Use

The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

Device Story

The SYNCHRON Systems Alcohol (ALC) Reagent is an in vitro diagnostic assay used on Beckman clinical chemistry analyzers (e.g., SYNCHRON LX20) to measure alcohol concentration in human serum or plasma. The device utilizes an enzymatic Alcohol Dehydrogenase (ADH) reaction to produce a measurable signal, which is detected via endpoint measurement at 340 nm. The system requires the use of a SYNCHRON Systems Alcohol Calibrator. It is intended for use by clinical laboratory professionals to assist in the diagnosis and treatment of alcohol intoxication and poisoning. The device provides quantitative results that aid clinicians in assessing patient alcohol levels.

Clinical Evidence

Bench testing only. Method comparison study (n=78) against the DCL Ethanol Assay yielded a slope of 1.037, intercept of 0.34 mg/dL, and correlation coefficient (r) of 0.9986. Within-run imprecision was evaluated across three levels in the default range (51.4-239.7 mg/dL) with %CVs of 1.33-1.73%, and two levels in the extended range (287.55-488.63 mg/dL) with %CVs of 1.24%.

Technological Characteristics

Enzymatic assay using Alcohol Dehydrogenase (ADH). Endpoint spectrophotometric measurement at 340 nm. Multi-reagent kit requiring preparation. Calibrated with single-level aqueous calibrator. Designed for automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of alcohol in human serum or plasma for the diagnosis and treatment of alcohol intoxication and poisoning.

Regulatory Classification

Identification

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Predicate Devices

• DCL Ethanol Assay (K923783, K924733)

Submission Summary (Full Text)

{0}------------------------------------------------

Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

K971506

JUN - 3 1997

# Summary of Safety & Effectiveness SYNCHRON® Systems Alcohol (ALC) Reagent

### Submitted By: 1.0

Maria Zeballos Scientist II, Chemistry Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-150 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

18 April 1997

#### 3.0 Device Name(s):

## 3.1 Proprietary Names

SYNCHRON® Systems Alcohol (ALC) Reagent

## 3.2 Classification Names

Alcohol Test system (21 CFR 862.3040)

### 4.0 Predicate Device(s):

| SYNCHRON<br>Reagent | Predicate | Predicate Company | Docket<br>Number |
|----------------------------------------------|----------------------|-------------------------------------------------------------------------|--------------------|
| SYNCHRON<br>Systems Alcohol<br>(ALC) Reagent | DCL Ethanol<br>Assay | Diagnostic Chemicals<br>Limited (DCL),<br>Charlottetown, PEI,<br>Canada | K923783<br>K924733 |

{1}------------------------------------------------

Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

#### Description: 5.0

The SYNCHRON Systems Alcohol (ALC) Reagent in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.

#### Intended Use: 6.0

The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

#### 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/<br>Characteristic | Comments |
|----------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON<br>Systems Alcohol<br>(ALC) Reagent | Intended use | Same as DCL Ethanol Assay Kit;<br>determination of alcohol<br>concentration in serum or plasma |
| | Chemical reaction | Same as DCL Ethanol Assay Kit;<br>enzymatic, Alcohol<br>Dehydrogenase (ADH) reaction |
| | Formulation | Same as DCL Ethanol Assay Kit |
| | Measurement<br>method | Same as DCL Ethanol Assay Kit;<br>endpoint measurement at 340 nm |
| | Packaging | Same as DCL Ethanol Assay Kit;<br>a multi reagent kit that requires<br>preparation. |
| | Calibration | Same as DCL Ethanol Assay Kit;<br>single level aqueous calibrator |

{2}------------------------------------------------

SUNE INFE

| Reagent | Aspect/Characteristic | Comments |
|-------------------------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| SYNCHRON<br>Systems<br>Alcohol (ALC)<br>Reagent | Range expansion | The DCL Ethanol Assay Kit<br>measures alcohol concentrations at<br>the initial range of 5 -250 mg/dL;<br>while the SYNCHRON Systems<br>ALC reagent measures alcohol<br>concentrations at the initial range of<br>5 - 250 mg/dL and expanded range<br>of 200 - 500 mg/dL |

### Summary of Performance Data: 8.0

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 studies and imprecision experiments that relate results obtained from SYNCHRON Systems Alcohol Reagent.

# Method Comparison Study Results SYNCHRON Systems Alcohol (ALC) Reagent

| Reagent<br>(Analyte) | Slope | Intercept<br>(mg/dL) | r | n | Predicate<br>Method |
|-------------------------------------------------|-------|----------------------|--------|----|--------------------------------------------------------------|
| SYNCHRON<br>Systems<br>Alcohol (ALC)<br>Reagent | 1.037 | 0.34 | 0.9986 | 78 | DCL Ethanol<br>Assay Kit on<br>the<br>SYNCHRON<br>CX Systems |

{3}------------------------------------------------

Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

| Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N |
|---------------------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision Default Range | | | | |
| Level 1 | 51.4 | 0.89 | 1.73 | 80 |
| Level 2 | 102.2 | 1.57 | 1.53 | 80 |
| Level 3 | 239.7 | 3.19 | 1.33 | 80 |
| Within-Run Imprecision Extended Range | | | | |
| Level 1 | 287.55 | 3.58 | 1.24 | 20 |
| Level 2 | 488.63 | 6.08 | 1.24 | 20 |

# Estimated Within-Run Imprecision Alcohol 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.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 3 1997

Sheri Hall Manager, Premarket Regulatory Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000

K971506 Re : SYNCHRON® Systems Alcohol (ALC) Reagent Requlatory Class: II Product Code: DIC, DMT Dated: April 18, 1997 Received: April 25, 1997

Dear Ms. Hall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{5}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will atlow you to begin marketing your device as i described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

510(k) Number (if known):

Device Name: SYNCHRON® Systems Alcohol (ALC) Reagent

Indications for Use:

The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

21 CFR 862.3040 Alcohol test system

(a) Identification. An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

(b) Classification. Class II.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-on)
Division of Clinical Laboratory Devices

510(k) Number
K971506

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96