SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

K993022 · Beckman Coulter, Inc. · DLJ · Nov 9, 1999 · Clinical Toxicology

Device Facts

• Record ID: K993022
• Device Name: SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
• Applicant: Beckman Coulter, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.

Device Story

SYNCHRON Systems OP 300 Low and High Urine Calibrators are liquid, human urine-based calibrators containing known quantities of morphine. Used in clinical laboratory settings on SYNCHRON Systems to calibrate Opiate 300 ng enzyme immunoassays. Calibrator concentrations are traceable to Gas Chromatography/Mass Spectrometry (GC/MS). By establishing a calibration curve, the device enables the SYNCHRON system to accurately quantify opiate levels in patient urine samples, assisting healthcare providers in clinical toxicology assessments.

Clinical Evidence

No clinical data provided. The device is a calibrator; performance is established through traceability to GC/MS reference methods.

Technological Characteristics

Liquid, human urine-based calibrators. Contains morphine. Traceable to GC/MS. Storage at +2°C to +8°C. Designed for use with SYNCHRON Systems enzyme immunoassays.

Indications for Use

Indicated for use as a calibration tool for Opiate 300 ng enzyme immunoassays on SYNCHRON Systems. No specific patient population is described as this is an in vitro diagnostic calibrator.

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

• SYNCHRON® Systems DAT Low and High Urine Calibrators II (K983747)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness SYNCHRON® Systems OP 300 Low and High Urine Calibrators

### 1.0 Submitted By:

Gail Lefebvre Associate 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:

September 7, 1999

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON® Systems OP 300 Low and High Urine Calibrators

#### 3.2 Classification Name

Clinical Toxicology Calibrator (21 CFR § 862.3200)

## 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------------------------------------|------------------------------------------------------------------|-----------------------|------------------|
| SYNCHRON® Systems<br>OP 300 Low and High<br>Urine Calibrators | SYNCHRON®<br>Systems DAT Low<br>and High Urine<br>Calibrators II | Beckman Coulter, Inc. | K983747 |

#### 5.0 Description:

The SYNCHRON® Systems OP 300 Low and High Urine Calibrators are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng enzyme immunoassays. This product contains a 5.0 mL bottle of the Low Urine Calibrator and a 5.0 mL bottle of the High Urine Calibrator. The storage temperature for the calibrators is +2°C to +8°C.

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

Telephone: [phone] Facsimile: [phone] Internet: www.beckmancoulter.com

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 9 1999

Ms. Gail Lefebvre Associate Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Brea. California 92822-8000

- Re: K993022
Trade Name: SYNCHRON® Systems OP 300 Low and High Urine Calibrators Regulatory Class: II Product Code: DLJ Dated: September 7, 1999 Received: September 9, 1999

Dear Ms. Lefebvre:

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 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 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 of

510(k) Number (if known): K993022

Device Name: SYNCHRON® Systems OP 300 Low and High Urine Calibrators

Indications for Use:

The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.

## Clinical Significance:

The OP Low and High Urine Calibrators are ready-to-use human, urine-based. liquid calibrators. They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration.

Jean Cooper
(Division Sign-Off)
Division of Clinical Labora
ces
510(k) Number K993022

(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