SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

K994325 · Beckman Coulter, Inc. · JIS · Jan 12, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994325
• Device Name: SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The SYNCHRON CX Systems Microalbumin Calibrator is a six-level calibrator intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin (MA) reagent.

Device Story

SYNCHRON CX Systems Microalbumin Calibrator is a six-level liquid, ready-to-use calibrator; used in clinical laboratory settings by trained personnel. It establishes reference points for the SYNCHRON CX Systems to calibrate Microalbumin reagent. The calibrator consists of a pH buffer with added human serum albumin. It is traceable to the IFCC reference preparation for plasma proteins (CRM 470). By providing standardized reference values, it enables the system to accurately quantify microalbumin levels in patient samples, assisting clinicians in assessing renal function and monitoring disease states. The device is stored at 2°C to 8°C.

Clinical Evidence

Bench testing only. Stress stability studies support a 24-month shelf-life claim.

Technological Characteristics

Six-level liquid calibrator; ready-to-use. Composition: pH buffer with human serum albumin. Traceability: IFCC reference preparation for plasma proteins (CRM 470). Storage: 2°C to 8°C.

Indications for Use

Indicated for use as a six-level calibrator on SYNCHRON CX Systems to calibrate Microalbumin (MA) reagent for the measurement of microalbumin in human specimens.

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

• Beckman Immunochemistry Systems Urine Protein Calibrator (UCAL) (K973928)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness SYNCHRON CX® Systems Microalbumin Calibrator

## 1.0 Submitted By:

Gail Lefebre Associate Requlatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

December 17, 1999

## 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON CX® Systems Microalbumin Calibrator

#### 3.2 Classification Name

Calibrator, Primary (21 CFR § 862.1150)

## 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|----------------------------------------------------|--------------------------------------------------------------------------|-----------------------|------------------|
| SYNCHRON CX®<br>Systems Microalbumin<br>Calibrator | Beckman<br>Immunochemistry<br>Systems Urine Protein<br>Calibrator (UCAL) | Beckman Coulter, Inc. | K973928 |

## 5.0 Description:

The SYNCHRON CX® Systems Microalbumin Calibrator , when used in conjunction with SYNCHRON Systems Microalbumin Systems Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin. This product contains a 3.0 mL bottle each of Levels 1 to 6 of Microalbumin Calibrator.

#### 6.0 Intended Use:

The SYNCHRON CX Systems Microalbumin Calibrator is a six-level calibrator intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin (MA) reagent.

Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821

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

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

994325

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## 7.0 Comparison to Predicate(s):

| Beckman Product | Predicate | Predicate Company | Docket Number |
|----------------------------------------------------|--------------------------------------------------------------------------|-----------------------|---------------|
| SYNCHRON CX®<br>Systems Microalbumin<br>Calibrator | Beckman<br>Immunochemistry Systems<br>Urine Protein Calibrator<br>(UCAL) | Beckman Coulter, Inc. | K973928 |

| Reagent | Aspect/Characteristic | Comments |
|--------------------------------------|-------------------------------------------------------------------------------------|--------------|
| SYNCHRON Systems CX MA<br>Calibrator | Intended for calibration of urine<br>Microalbumin reagents | Same as UCAL |
| | Storage Temperature (+2°C to +8°C) | |
| | Liquid, ready-to-use form | |
| | Value Assignment Methodology | |
| | Traceable to the IFCC reference<br>preparation for plasma proteins, lot CRM<br>470. | |

| Reagent | Aspect/<br>Characteristic | Comments |
|--------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON CX Systems<br>MA Calibrator | Intended Use: | SYNCHRON CX Systems MA Calibrator is<br>intended for use in calibration of SYNCHRON CX<br>Systems Microalbumin Reagent. |
| | | Beckman Immunochemistry Systems UCAL is<br>intended for use in calibration of microalbumin,<br>urine transferrin, alpha-1-microglobulin, and urine<br>immunoglobulin G on ARRAY®, ARRAY® 360,<br>and IMMAGE™ Immunochemistry Systems. |
| | Levels of<br>Analyte: | SYNCHRON Systems MA Calibrator: 6 levels |
| | | Beckman UCAL: 4 levels |
| | Source<br>Material: | CX MA pH buffer to which human serum albumin<br>has been added |
| | | UCAL is prepared from human urine to which<br>albumin has been added |

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability studies of the Microalbumin calibrator support the Beckman stability claim of 24 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 2 2000

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

Re: K994325

> Trade Name: SYNCHRON CX® Systems Microalbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 17, 1999 Received: December 22, 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 (OS) 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 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 _**

510(k) Number (if known): \$994325

Device Name: SYNCHRON CX® Systems Microalbumin Calibrator

# Indications for Use:

MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.

## Clinical Significance:

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.

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994325

(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)

(per 21 CFR 801.109)

OR

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