MODIFICATION TO SYNCHRON CONTROL

K013235 · Beckman Coulter, Inc. · JJY · Oct 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013235
• Device Name: MODIFICATION TO SYNCHRON CONTROL
• Applicant: Beckman Coulter, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 16, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other; Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.

Device Story

SYNCHRON® Control is a quality control material consisting of three levels of stabilized human serum; used in clinical laboratories to monitor the performance of SYNCHRON Systems. The device provides a quantitative relationship between levels 1, 2, and 3; level 2 is created by mixing equal parts of levels 1 and 3. Laboratorians use these controls to assess calibration, linearity, analytical error, and imprecision of the SYNCHRON Systems. The modified version includes vancomycin. The device benefits patients by ensuring the accuracy and reliability of clinical laboratory test results.

Clinical Evidence

Bench testing only. Stress stability studies were conducted to support an 18-month stability claim.

Technological Characteristics

Quality control material composed of stabilized human serum and defibrinated, stabilized human plasma. Stabilized with ethylene glycol. Contains vancomycin. Formulated in three levels (1, 2, and 3) with a quantitative relationship between levels.

Indications for Use

Indicated for use in clinical laboratories to monitor the performance of SYNCHRON Systems. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic quality control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• SYNCHRON® Control (K003488)

Submission Summary (Full Text)

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K013235

### 510(k) Summary SYNCHRON® Control

#### Submitted By: 1.0

Mary Beth Tang Mary Both Sale Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

OCT 1 6 2001

#### Date Submitted: 2.0

September 26, 2001

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON® Control

#### Classification Name 3.2

Quality Control Material (21 CFR §862.1660)

#### Predicate Device(s): 4.0

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------|-------------------|-----------------------|------------------|
| SYNCHRON® Control | SYNCHRON® Control | Beckman Coulter, Inc. | K003488 |

#### 5.0 Description:

The SYNCHRON® Control kit consists of three levels of controls (Level 2, and The SYNCHRON® Control KE consiste of three free are a total of 6 bottles (two 20-mL
Level 3) for use on the SYNCHRON Systems. There free are a total of 6 bottles (two 20-mL Level 3) for use on the STNCHRON® Controls are made from stabilized human serum and bottles perferen. STNOrth of control and most of SYNCHRON Systems in the clinical are designed to "monitor" the "personnance" of of frozen human plasma that has been defibrinated and, then, it is stabilized with ethylene glycol.

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#### 6.0 Intended Use:

SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other; Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.

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

The modified SYNCHRON Control claims substantial equivalence to the SYNCHRON Control currently in commercial distribution (K003488). The modified SYNCHRON Control contains vancomycin and the current product does not.

#### 8.0 Summary of Performance Data:

Stress stability studies of the SYNCHRON Control support the 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 6 2001

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Box 8000 Brea, California 92822-8000

Re: k013235

Trade/Device Name: SYNCHRON® Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: September 26, 2001 Received: September 28, 2001

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, ins casordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, manov and include requirements for annual registration, listing of general controls provisions of aactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinod (600 a00 rols. Existing major regulations affecting your device can may or subject to back acceler as egulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I house of actived that I Drivice and that your device complies with other requirements of the Act that I Drines intatutes and regulations administered by other Federal agencies. You must or any I odolar statuation and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF I rat 007); adoling (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 notheation. The I Drice 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 1 IT you desire specific arrive for fist assic devices), please contact the Office of Compliance at additionally 607.10 for in the examplestions on the promotion and advertising of your device, [phone]. Routlonally, 10. quese at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionates and er Assistance at its toll-free number [phone] or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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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### Indications for Use Statement

page_1_of_1_

510(k) Number (if known): Not yet assigned KO13235

SYNCHRON® Control Device Name:

## Indications for Use:

SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other; Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Kesia Alexander for Jean Cooper |
|-----------------------------------------|---------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (per 21 CFR 801.109) OR

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