SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR

K994168 · Beckman Coulter, Inc. · JIS · Feb 3, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994168
• Device Name: SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The SYNCHRON® LX Systems Prealbumin Calibrator is intended for use with the SYNCHRON LX Systems for the calibration of Prealbumin (PAB) reagent.

Device Story

SYNCHRON LX Systems Prealbumin Calibrator is a ready-to-use, human serum-based liquid calibrator. It is used in clinical laboratory settings by trained personnel to establish reference points for the SYNCHRON LX Systems when measuring prealbumin levels in patient samples. The calibrator is traceable to the IFCC reference preparation for plasma proteins (CRM 470). By calibrating the test system, it ensures the accuracy of prealbumin measurements, which are used by clinicians to assess patient nutritional status or inflammatory states. The device is stored at 2°C to 8°C.

Clinical Evidence

Bench testing only. Stability studies support a 24-month shelf life.

Technological Characteristics

Human serum-based liquid calibrator; ready-to-use; single analyte level; stored at 2°C to 8°C; traceable to IFCC CRM 470.

Indications for Use

Indicated for use on Beckman SYNCHRON LX Systems to calibrate prealbumin test systems for the measurement of prealbumin 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 CAL 3 (K854811)

Submission Summary (Full Text)

{0}------------------------------------------------

### 3 2000 FEB

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye or leaf. To the right of the circle is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The two words are stacked vertically, with "BECKMAN" on top of "COULTER."

K994168

Summary of Safety & Effectiveness SYNCHRON® LX Systems Prealbumin Calibrator

#### 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:

December 6, 1999

#### 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® LX Systems Prealbumin Calibrator

#### 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>PAB Calibrator | Beckman<br>Immunochemistry<br>Systems CAL 3 | Beckman Coulter, Inc. | K854811 |

#### 5.0 Description:

The SYNCHRON Systems Prealbumin Calibrator is a ready-to-use human serum-based liquid calibrator manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of the calibrator.

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

{1}------------------------------------------------

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® LX Systems Prealbumin Calibrator Summary of Safety & Effectiveness

#### 5.0 Intended Use:

The SYNCHRON® LX Systems Prealbumin Calibrator is intended for use with the SYNCHRON LX Systems for the calibration of Prealbumin (PAB) reagent.

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

| Reagent | Aspect/Characteristic | Comments |
|------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------|
| SYNCHRON LX<br>Systems PAB<br>Calibrator | Source Material: Fresh frozen human<br>plasma that has been defibrinated and<br>processed. | Same as Beckman<br>CAL 3 |
| | Storage Temperature (+2°C to +8°C) | |
| | Liquid, ready-to-use form | |
| | One level of analyte | |
| | Value Assignment Methodology | |
| | Traceable to the IFCC reference<br>preparation for plasma proteins, lot CRM<br>470. | |

| Reagent | Aspect/Characteristic | Comments |
|---------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON<br>LX Systems<br>PAB<br>Calibrator | Intended Use: | SYNCHRON LX Systems PAB Calibrator is<br>intended for use in calibration of SYNCHRON<br>LX Systems Prealbumin Reagent.<br>Beckman CAL 3 is intended for use in<br>calibration of albumin and prealbumin on<br>ARRAY®, ARRAY® 360, and IMMAGE™<br>Immunochemistry systems |

#### 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 Prealbumin 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized depiction of three human figures, representing the department's focus on people and their well-being. The figures are rendered in a simple, abstract style.

### 3 2000 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K994168

> Trade Name: SYNCHRON® LX Systems Prealbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 6, 1999 Received: December 10, 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.

{3}------------------------------------------------

# Page 2

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" (21CFR 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 Butman

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

{4}------------------------------------------------

page | of |

510(k) Number (if known):

: 13774168
ON@LX Systems

Device Name: SYNCHRON® LX Systems Prealbumin Calibrator

Indications for Use:

The SYNCHRON® LX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON LX Systems for the calibration of prealbumin test systems.

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 Coogy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 9941(08

(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