SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

K983709 · Beckman Coulter, Inc. · DIF · Oct 28, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983709
• Device Name: SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
• Applicant: Beckman Coulter, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The SYNCHRON® Systems DAT Low and High Urine Controls 1. in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.

Device Story

SYNCHRON® Systems DAT Low and High Urine Controls 1 are liquid control materials used in clinical laboratories; designed for monitoring quality control of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents on SYNCHRON systems. Laboratory technicians use these controls to estimate test system precision and detect systematic deviations from accuracy caused by reagent or instrument defects. The controls provide a benchmark for verifying assay performance, ensuring reliable clinical toxicology results for patient samples.

Clinical Evidence

Bench testing only. Stress stability studies were conducted to support an 18-month shelf life claim. No clinical data provided.

Technological Characteristics

Liquid control material for clinical toxicology. Designed for use with SYNCHRON system instrumentation. Class I device (21 CFR 862.3280).

Indications for Use

Indicated for use in clinical laboratories as a quality control material to monitor the precision and accuracy of SYNCHRON system test assays for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Drugs of Abuse Urine Calibrators (K920477)

Submission Summary (Full Text)

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OCT 28 1998

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved lines inside, resembling a stylized eye or a symbol of interconnectedness. To the right of the symbol, the words "BECKMAN COULTER" are written in bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

K 983709

Summary of Safety & Effectiven SYNCHRON® Systems DAT Low and High Urine Controls 1

## Submitted By: 1.0

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

## Date Submitted: 2.0

October 19, 1998

## 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems DAT Low and High Urine Controls 1

## Classification Name 3.2

Control Material, Clinical Toxicology (21 CFR §862.3280)

## 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. * | K920477 |

*Diagnostic Regents, Inc. Mountain View, CA

## 5.0 Description:

The SYNCHRON® Systems DAT Low and High Urine Controls 1 are used for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine reagents in the clinical laboratory.

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#### 5.0 Intended Use:

.

The SYNCHRON® Systems DAT Low and High Urine Controls 1. in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.

#### 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 controls already in commercial distribution. Stress stability studies of the DAT Low and High Unne Controls 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 requiration 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN USA

OCT 28 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K983709

Trade Name: SYNCHRON® Systems DAT Low and High Urine Controls 1 Regulatory Class: I Product Code: DIF Dated: October 19, 1998 Received: October 21, 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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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## 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 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

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page _ of _

K983709

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

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

Indications for Use:

The SYNCHRON® Systems DAT Low and High Urine Controls 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.

21 CFR 862.3280 Control Material, Clinical Toxicology

(a) Identification. A clinical toxicology control is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

(b) Classification. Class I.

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

(Division Sign-Off) Division of Clinical Labora 510(k) Number OR Over-the-Counter Use (per 21 CFR 801.109) Optional Format 1-2-96

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U