SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I

K983209 · Beckman Coulter, Inc. · DKB · Nov 4, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983209
• Device Name: SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
• Applicant: Beckman Coulter, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.

Device Story

SYNCHRON® Systems DAT Low and High Urine Calibrators 1 are liquid calibrators used in clinical laboratories to calibrate enzyme immunoassays for drugs of abuse (Amphetamines, Cocaine Metabolite, Opiate 2000 ng, Phencyclidine) on Beckman SYNCHRON Systems. The calibrators provide reference points for the system to quantify drug concentrations in human urine samples. Laboratory technicians use these calibrators to ensure the accuracy of the SYNCHRON analyzer's measurement of patient samples. By establishing a calibration curve, the device enables the system to report reliable drug concentration values, which clinicians use to assess patient toxicology status.

Clinical Evidence

Bench testing only. Stress stability studies were conducted to support an 18-month shelf life claim. No clinical data was required for this submission.

Technological Characteristics

Liquid calibrator mixture for drugs of abuse. Designed for use with SYNCHRON Systems enzyme immunoassays. Stability: 18 months.

Indications for Use

Indicated for use as clinical toxicology calibrators to establish points of reference for the measurement of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in human urine specimens using Beckman SYNCHRON Systems.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special 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.

Predicate Devices

• Drugs of Abuse Urine Calibrators (K920208)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized leaf or wave. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font. The overall design is clean and modern, conveying a sense of professionalism and innovation.

### Summary of Safety & Effectiveness SYNCHRON® Systems DAT Low and High Urine Calibrators 1

#### 1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

October 20, 1998

### 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON® Systems DAT Low and High Urine Calibrators 1

### 3.2 Classification Name

Calibrator, Drug Mixture (21 CFR §862.3200)

### 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------------------------------------|-------------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems<br>DAT Low and High<br>Urine Controls 1 | Drugs of Abuse Urine<br>Calibrators | Diagnostic Reagents,<br>Inc.* | K920208 |

*Diagnostic Reagents, Inc. Sunnyvale, CA

#### 5.0 Description:

The SYNCHRON® Systems DAT Low and High Urine Calibrators 1 are used for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassay on Beckman SYNCHRON® Systems.

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#### 5.0 Intended Use:

The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.

#### 7.0 Comparison to Predicate(s):

Identical to predicate product with Beckman Coulter, Inc. label and increased level of Opiate analyte.

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology calibrators already in commercial distribution. Stress stability studies of the DAT Low and High Unine Calibrators 1 support the Beckman stability claim of 18 months.

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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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal features a stylized image of an eagle with its wings spread, with three human figures underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

NOV 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea. California 92822-8000

Re: K983209

Trade Name: SYNCHRON Systems DAT and High Urine Calibrators 1 Regulatory Class: II Product Code: DKB Dated: September 10, 1998 Received: September 14, 1998

Dear Ms. Stockert:

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 legally marketed predicate 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 allow you to begin marketing your device as 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 regulation (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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

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

A. L.

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page _____ of ________________________________________________________________________________________________________________________________________________________________

# 1983209

## 510(k) Number (if known): Not yet assigned

Device Name: SYNCHRON® Systems DAT Low and High Urine Calibrators 1

Indications for Use:

The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.

### 21 CFR 862.3200 Calibrators, Drug Mixture

(a) Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug.

(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)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K983209 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(per 21 CFR 801.109)<br><div>✓</div> | OR | Over-the-Counter Use<br>Optional Format 1-2-96 |
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