SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS

K993954 · Beckman Coulter, Inc. · DKB · Jan 11, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993954
• Device Name: SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
• Applicant: Beckman Coulter, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Jan 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.

Device Story

The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are ready-to-use, human urine-based materials. They are used in clinical laboratory settings on SYNCHRON Systems to calibrate enzyme immunoassays for detecting specific drugs of abuse (Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene). By establishing reference points for these assays, the calibrators enable the system to accurately quantify drug concentrations in patient urine samples. This process supports healthcare providers in clinical toxicology testing and decision-making regarding drug presence.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically stress stability studies confirming a 12-month shelf life.

Technological Characteristics

Ready-to-use human urine-based calibrator material. Designed for use with SYNCHRON Systems enzyme immunoassays. No specific materials of construction, energy sources, or software algorithms are described beyond the chemical nature of the calibrator.

Indications for Use

Indicated for use as a clinical toxicology calibrator to establish points of reference for the measurement of drugs of abuse in human urine specimens using SYNCHRON Systems enzyme immunoassays.

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

• Multi-Drug Urine Calibrators (K983159)

Submission Summary (Full Text)

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K993954

## JAN 1 1 2000

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with a white wave-like design inside. To the right of the circle are the words "BECKMAN" in a larger, bolder font, stacked above the word "COULTER" in a slightly smaller font. The logo is simple and modern, with a focus on the company name.

Summary of Safety & Effectiveness SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators

#### 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:

November 16, 1999

#### 3.0 Device Name(s):

## 3.1 Proprietary Names

SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators

#### 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>Multi-Drug DAT Low<br>and High Urine<br>Calibrators | Multi-Drug Urine<br>Calibrators | Diagnostic Reagents,<br>Inc.* | K983159 |

*Diagnostic Reagents, Inc. Sunnyvale, CA

#### 5.0 Description:

The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are readyto-use human urine-based calibrator materials.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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#### 5.0 Intended Use:

The SYNCHRON® Systems DAT Multi-Druq Low and High Urine Calibrators, in coniunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.

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

Identical to predicate product but labeled for Beckman Coulter, Inc.

#### 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 Multi-Drug Low and High Urine Calibrators support the Beckman stability claim of 12 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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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with two snakes entwined around it, topped with a pair of wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# 'JAN 1 1 2000

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

Re: K993954

Trade Name: SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators Regulatory Class: II Product Code: DKB Dated: November 16, 1999 Received: November 22, 1999

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 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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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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 _________________________________________________________________________________________________________________________________________________________________________

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

Device Name: SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators

Indications for Use:

The SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene 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.

Sean Cooper

Division Sign-Off) Division of Clinical Laboratory Devices 993954 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR

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