RANDOX DIGOXIN ASSAY

K102346 · Randox Laboratories, Ltd. · KXT · Oct 14, 2011 · Clinical Toxicology

Device Facts

• Record ID: K102346
• Device Name: RANDOX DIGOXIN ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Oct 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The Randox Laboratories Digoxin Assay is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma. Quantitative measurements are used in the diagnosis and treatment of Digoxin overdose and in monitoring levels of Digoxin to ensure appropriate therapy. This device has been developed for the ADVIA system and is intended for prescription use only.

Device Story

Randox Digoxin Assay is an in vitro diagnostic test for quantitative measurement of Digoxin in human serum or plasma. Designed for use on the ADVIA system; operated by laboratory professionals in clinical settings. Provides quantitative results to clinicians for assessing Digoxin overdose and therapeutic drug monitoring. Enables adjustment of patient medication regimens to ensure appropriate therapy and prevent toxicity.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 replicates/sample over 20 days); total CVs ranged from 1.8% to 11.0%. Linearity confirmed from 0.41 to 5.79 ng/mL (R^2=0.9912). LoQ established at 0.4 ng/mL. Method comparison against predicate (n=56) yielded y=0.97x-0.22, r=0.984. Matrix comparison (serum vs. Li-Heparin plasma, n=40) yielded y=1.03x-0.060, r=0.991. Interference and cross-reactivity studies showed no significant impact from common endogenous substances or structurally related compounds.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: mouse monoclonal anti-digoxin antibody, digoxin-coated latex beads, sodium azide. Instrumentation: ADVIA 1650 system. Measurement: light scattering (absorbance at 694 nm). Measuring range: 0.4–5.0 ng/mL. Calibration interval: 7 days. Traceable to USP material.

Indications for Use

Indicated for the quantitative determination of Digoxin in human serum or plasma for the diagnosis and treatment of Digoxin overdose and monitoring of therapeutic levels.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond Rd. Crumlin, County Antrim United Kingdom BT29 4QY

OCT 1 4 2011

Re: k102346

Trade/Device Name: Randox Digoxin Assay Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin Test System Regulatory Class: Class II Product Code: KXT - Dated: September 16, 2011 Received: September 19, 2011

## Dear Dr. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for dolor surverior 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) that do not require approval of a premarket approval application (PMA). unde oo.metre fore, 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

## Enclosure

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## Indication for Use

510(k) Number (if known): k102346

Device Name: Digoxin Test Kit

Indication For Use:

The Randox Laboratories Digoxin Assay is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma.

Quantitative measurements are used in the diagnosis and treatment of Digoxin overdose and in monitoring levels of Digoxin to ensure appropriate therapy.

This device has been developed for the ADVIA system and is intended for prescription use only.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use __ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Dan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102346