RANDOX ALBUMIN

K984494 · Randox Laboratories, Ltd. · CIX · Mar 23, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984494
• Device Name: RANDOX ALBUMIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Randox Albumin Test Kit is an in vitro diagnostic reagent for quantitative serum albumin measurement. Principle: reaction of serum albumin with Bromocresol Green (BCG) indicator to form a colored complex; absorbance measured at 578nm. Used in clinical laboratory settings by qualified personnel. Output is a quantitative albumin concentration value. Clinicians use results to diagnose and monitor hypoalbuminaemia related to liver/kidney disease, malnutrition, malabsorption, burns, or dermatitis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent; Bromocresol Green (BCG) colorimetric assay; detection wavelength 578nm; manual or automated clinical chemistry analyzer compatible.

Indications for Use

Indicated for the quantitative determination of albumin in serum to aid in the diagnosis and treatment of hypoalbuminaemia associated with liver disease, kidney disease, malnutrition, malabsorption, burns, or dermatitis. For use by qualified laboratory personnel.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR 2 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. P. Armstrong Regulatory Affairs RANDOX LABORATORIES LTD. Biochemical Manufacturers Ardmore, Diamond Road Co. Antrim UNITED KINGDOM BT29 4QY

Re: K984494 Trade Name: Randox Albumin Regulatory Class: II Product Code: CIX Dated: January 21, 1999 Received: February 12, 1999

## Dear Dr. Armstrong:

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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| Page of | 1 of 1 |
|---------|--------|
|---------|--------|

| 510(k) Number (if known) | UNKNOWN K984494 |
|--------------------------|------------------------------------|
| Device Name | ALBUMIN (BROMOCRESOL GREEN METHOD) |

## Indications For Use :

The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis.

This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Sean Cooper

vision Sign-Off vision of Clinical Laboratory Devices 1984494 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional format 1-2-96)