RANDOX DIGITOXIN

K012112 · Randox Laboratories, Ltd. · LFM · Jan 11, 2002 · Clinical Toxicology

Device Facts

• Record ID: K012112
• Device Name: RANDOX DIGITOXIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: LFM · Clinical Toxicology
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3300
• Device Class: Class 2

Intended Use

Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic reagent intended for the quantitative determination of digitoxin in serum. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate lab conditions.

Device Story

In vitro diagnostic test kit for quantitative serum digitoxin measurement; utilizes agglutination inhibition principle. Latex particles coated with digitoxin complex; sample containing digitoxin competes for binding sites; agglutination inhibition occurs proportional to digitoxin concentration. Change in scattered light measured as change in absorbance; concentration determined via standard curve. Used in clinical laboratory settings; operated by qualified laboratory personnel. Compatible with Hitachi 717 and Advia 1650 analyzers. Output provides digitoxin concentration levels; assists clinicians in therapeutic drug monitoring and managing potential overdose; supports optimized patient dosing.

Clinical Evidence

No clinical data provided. Device relies on bench testing and performance verification on specified clinical chemistry analyzers (Hitachi 717 and Advia 1650).

Technological Characteristics

In vitro diagnostic reagent; latex agglutination inhibition assay. Measures absorbance changes proportional to digitoxin concentration. Designed for use on automated clinical chemistry analyzers (Hitachi 717, Advia 1650).

Indications for Use

Indicated for the quantitative determination of digitoxin in serum for patients requiring monitoring of digitoxin levels to ensure appropriate therapy or for the diagnosis and treatment of digitoxin overdose.

Regulatory Classification

Identification

A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Submission Summary (Full Text)

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JAN 1 1 2002

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1. Sale

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Heather Anderson Regulatory Affairs Randox Laboratories, Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY

k012112 Re: Trade/Device Name: Digitoxin Regulation Number: 21 CFR 862.3300 Regulation Name: Digitoxin test system Regulatory Class: Class I Product Code: LFM Dated: October 23, 2001 Received: October 29, 2001

## Dear Dr. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainer is substantially equivalent (for the indications reterenced above and nave determined the actives marketed pressmarketed in interstate for use stated in the enclosure) to regary market prourises and the Federal Food. Device American of the Federal Food. Drug. commerce prior to May 28, 1970, the enaculiers with the provisions of the Federal Food. Drug, devices that have been reciassince in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Ac and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, secycle requirements for annual registration, listing of
general controls provisions of the Act include requirements increasing and general controls provisions of the Act mercial or quarter biting against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo exist one regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may may be subject to such adultional Colleois: Existing major sogges In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio be found in the Code of Federal Regerains your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a subscribes with other requirements of the Act
that FDA has made a determination that your device of a Forel accepcios. You must that FDA has made a decemmanon that your and read by other Federal agencies. You must or any Federal statures and regulations daminities on registration and listing (21 l
comply with all the Act's requirements, including, but not limited to: resimments as set comply with all the Act s requirements, me; good manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electronic CFK Part 807); labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic form in ine quality systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin nakence of your device of your device to a legally marketed notification. The FDA Intuilig of substantial equivaliation 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 If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please cander time of your d additionally 809.10 for in viuo diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions of [phone]. Also, please note the regulation please contact the Office of Compliance and prematical colorized from the Division of Small entitled, "Misbranding by telefence to promation the Act may be obtained from the Division of Small
information on your responsibilities under the Act was at its tall frem th information on your responsibilities most us issuance at its toll-free number [phone] or
Manufacturers International and Consumer Assistance at its toll-stramain html" Manufacturers international and Colisuner 1185562165 and 167 howw.fda.gov/odrh/dsma/dsmamain.html".
[phone] or at its internet address "http://www.fda.gov/cdrh/dsma/ds

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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k) Number (if known): -

DIGITOXIN

-Not Known

ce Name:

## ications For Use :

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ing particles are coated on the aggioxin in the easy many money onli ican is partialion occurs. When its aggiutination process. The factor in the sample. By the Unitos that the Unition in the stam the obtain thersely dependent on the concentiation of the concentration curve can be can be concentration of digitoxin in
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KO12112

re sample.
Masurements obtained by this device are used in the diagnosis and treatment of digitoxin in
the sure of in monitering levels of digitoxin to ensure appropriate t theasurements obtained by this device are used in the diagnosis and in the many and

maso Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers
and and anyand by suitably qualified laboratory personnel under appropriate laborat inese Application Sheets have been developed for the Hitachi 77 and Author of the Alberton
and must be used by suitably qualified laboratory personnel under appropriate lab conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Jean Cooper</i> |
|---------------------------|--------------------|
| (Division Sign-Off) | |
| Division of Clinical Lab: | vices |
| 510(k) Number | K012112 |

OR

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

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