(51 days)
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 determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria for the Digoxin Immunoassay.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the Digoxin Immunoassay: "for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information for clinical management of patients administered digoxin, aiding the physician in monitoring digoxin levels to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, or details of a specific study.
- Details regarding number or qualifications of experts, or adjudication methods.
- Information on MRMC comparative effectiveness studies.
- Details on standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The caduceus is depicted with a modern, abstract design.
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.
{1}------------------------------------------------
Paqe 2
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
{2}------------------------------------------------
510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name:
.
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K983323 | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 862.3320 Digoxin test system.
(a)
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.(b)
Classification. Class II.