DIGOXIN IMMUNOASSAY

K983323 · Diagnostic Reagents, Inc. · KXT · Nov 12, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983323
• Device Name: DIGOXIN IMMUNOASSAY
• Applicant: Diagnostic Reagents, Inc.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information to help the clinician determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

Device Story

Digoxin Immunoassay; in vitro diagnostic test for quantitative measurement of digoxin in human serum or plasma. Used in clinical laboratory settings by trained personnel. Provides concentration data to clinicians to guide therapeutic dosing and avoid toxicity. Principle of operation involves immunoassay technology for analyte detection. Output is a numerical concentration value used for clinical decision-making regarding patient medication management.

Clinical Evidence

No clinical data provided; 510(k) clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

In vitro diagnostic immunoassay for quantitative analysis of digoxin. Form factor is a reagent-based assay system. No specific materials, connectivity, or software algorithm details provided in the source document.

Indications for Use

Indicated for the quantitative measurement of digoxin in human serum or plasma to assist clinicians in optimizing dosage for therapeutic efficacy and preventing toxicity.

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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NOV 1 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, California 94086

Re: K983323 Trade Name: Digoxin Immunoasssay Product Code: KXT Regulatory Class: II DLJ II Dated: September 21, 1998 September 22, 1998 Received:

Dear Dr. Tsay:

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 aqainst 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 A substantially equivalent determination assumes compliance to 895. 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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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 requlation 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 Putman

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 (if known): ___________________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________________

K983323

Device Name:

.

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DIGOXIN IMMUNOASSAY __________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin I he Digoxin Ininunoasay is intended for in viro dagate see as elegaxin concentrations provides critical in human setulir of plasma. Accurate determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="right">(Division Sign-Off)</div> <div align="right">Division of Clinical Laboratory Devices</div> <div align="right">510(k) Number <span style="text-decoration:underline;">k983323</span></div> |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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