RANDOX BILIRUBIN

K973995 · Randox Laboratories, Ltd. · GIG · Dec 8, 1997 · Hematology

Device Facts

• Record ID: K973995
• Device Name: RANDOX BILIRUBIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: GIG · Hematology
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7500
• Device Class: Class 2

Intended Use

The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent for the quantitative determination of total and direct bilirubin in human serum and plasma. This method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the sample is first incubated with caffeine which releases bilirubin from albumin. Direct (conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to evaluate jaundice. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Randox Bilirubin Test Kit is an in vitro diagnostic reagent system for clinical laboratory use. It measures total and direct bilirubin levels in human serum or plasma samples. Principle of operation: colorimetric assay using diazotized sulphanilic acid. Total bilirubin measurement involves sample incubation with caffeine to release bilirubin from albumin; direct bilirubin is measured without caffeine. The assay is performed by qualified laboratory personnel in a clinical setting. Results assist clinicians in diagnosing liver disease, detecting haemolytic anaemia, and evaluating jaundice.

Technological Characteristics

In vitro diagnostic reagent kit. Principle: Colorimetric assay using diazotized sulphanilic acid. Analyte: Total and direct bilirubin. Sample matrix: Human serum and plasma. Reagent includes caffeine for total bilirubin dissociation from albumin.

Indications for Use

Indicated for the quantitative determination of total and direct bilirubin in human serum and plasma for the diagnosis of liver disease, detection of haemolytic anaemia, and evaluation of jaundice. For use by qualified laboratory personnel.

Regulatory Classification

Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 8 1997

Dr. P. Armstrong Regulatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, BT29 4QY Co. Antrim, Ireland

K973995 Re : Randox Bilirubin Product Code: GIG Regulatory Class: II Dated: October 16, 1997 Received: October 21, 1997

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 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 General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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/dsmamain.html".

sincerely yours,
Steven Litman

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) | NOT KNOWN k973995 12-587 |
|--------------------------|--------------------------|
| Device Name | BILIRUBIN |

Indications For Use :

The Randox Laboratories Limited Bilirubin Test Kit is an *in vitro* diagnostic reagent for the
quantitative determination of total and direct bilirubin in human serum and plasma. This
method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the
sample is first incubated with caffeine which releases bilirubin from albumin. Direct
(conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin
are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to
evaluate jaundice.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional format 1-2-96) |

| (Division Sign-Off) | |
|---------------------|---------|
| Division | |
| 510(k) Number | k973995 |