SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K984014 · Beckman Coulter, Inc. · JIX · Dec 23, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984014
• Device Name: SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
• Applicant: Beckman Coulter, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values for specific for the LIP chemistry on SYNCHRON Systems.

Device Story

The SYNCHRON Systems Enzyme Validator Set consists of two levels of liquid calibrators (3 x 5 mL bottles each) used in clinical laboratories. The device provides reference points for calibrating enzyme assays on Beckman SYNCHRON Systems. By using this validator set, laboratory personnel ensure that assay values for human enzymes are compatible with standards recommended by the IFCC and DGKCh. The device is specifically used to assign lipase values for LIP chemistry on the SYNCHRON platform. It requires storage at -15°C to -20°C.

Clinical Evidence

No clinical data. Performance supported by bench testing, including stress stability studies confirming an 18-month stability claim.

Technological Characteristics

Liquid calibrator set (Levels 1 and 2); 3 x 5 mL bottles per level; storage temperature -15°C to -20°C. Calibrator for clinical laboratory enzyme assays.

Indications for Use

Indicated for use as a calibrator in clinical laboratory settings to establish reference points for the measurement of selected human enzymes in patient specimens using Beckman SYNCHRON Systems.

Regulatory Classification

Identification

A 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. (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 Enzyme Validator Set (K971333)
• SYNCHRON® Systems Enzyme Validator Set (K951964)

Submission Summary (Full Text)

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BEC 2 3 1998

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling an oval shape with a curved line running through it. To the right of the symbol, the words "BECKMAN" are stacked on top of "COULTER" in a bold, sans-serif font. The overall design is simple and professional, conveying a sense of innovation and reliability.

# Summary of Safety & Effectiveness SYNCHRON® Systems Enzyme Validator Set

#### 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 4, 1998

#### 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Enzyme Validator Set

#### 3.2 Classification Name

Calibrator (21 CFR §862.1150)

#### 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|-------------------------------------------|-------------------------------------------|--------------------------|--------------------|
| SYNCHRON® Systems<br>Enzyme Validator Set | SYNCHRON® Systems<br>Enzyme Validator Set | Beckman Coulter,<br>Inc. | K971333<br>K951964 |

#### 5.0 Description:

The SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 are used for calibration of various enzymes in the clinical laboratory. This consists of 3 X 5 mL bottles each of Levels 1 and 2. The storage temperature for this product is -15℃ to -20°C.

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

2 NOV 93
10 06

01300/нисэ/

4984014

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Enzyme Validator Set Summary of Safety & Effectiveness

#### 5.0 Intended Use:

The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values for specific for the LIP chemistry on SYNCHRON Systems.

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

Identical to predicate product with values assigned to the lipase analyte.

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to calibrators already in commercial distribution. Stress stability studies of the Enzyme Validator 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 23 1998

Lucinda Stockert Staff Regulatory Specialist, Product Submissions BECKMAN COULTER, INC. 200 S. Kraemer Blvd., W-104 Brea, CA 92822-8000

Re: K984014

> Trade Name: SYNCHRON® Systems Enzyme Validator Set Regulatory Class: II Product Code: JIX Dated: November 4, 1998 November 11, 1998 Received:

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, qood 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 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 requlatory 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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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

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

Device Name: SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2

Indications for Use:

The SYNCHRON® Systems Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values for specific for the LIP chemistry on SYNCHRON Systems.

21 CFR 862.1150 Calibrator

- (a) Identification. A 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.
(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)

K. L. Lappala

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984014

Prescription Use // (per 21 CFR 801.109)

OR

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