ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01

K990587 · Bio-Rad · DHR · Apr 7, 1999 · Immunology

Device Facts

• Record ID: K990587
• Device Name: ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
• Applicant: Bio-Rad
• Product Code: DHR · Immunology
• Decision Date: Apr 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

Abbott Liquid RF Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

Device Story

Abbott Liquid RF Control is a quality control serum used in clinical laboratories to monitor the precision of testing procedures for specific analytes. It serves as a reference material to verify that laboratory assays are performing within expected parameters. The product is used by laboratory technicians and clinicians to ensure the accuracy and reliability of patient test results. By comparing the measured values of the control serum against established ranges provided in the value sheet, the healthcare provider can identify potential errors or drift in the testing process, thereby ensuring high-quality diagnostic outcomes for patients.

Clinical Evidence

No clinical data provided; device is a quality control serum for laboratory use.

Technological Characteristics

Liquid quality control serum; intended for in vitro diagnostic use to monitor laboratory assay precision.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific analytes in a clinical laboratory setting.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## APR 7 1999

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K990587 Trade Name: Abbott Liquid RF Control Requlatory Class: II Product Code: DHR February 22, 1999 Dated: February 23, 1999 Received:

Dear Ms. Platt:

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.

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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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510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Abbott Liquid RF Control Device Name:

Indications for Use:

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Abbott Liquid RF Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

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

(Concurrence of CDRH, Office of Device Evaluation)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990587 |

| Prescription Use | OR | Over-The Counter Use |
|------------------|----|----------------------|
| ✓ | | |