(421 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring Digoxin levels and contains no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic test used for the quantitative determination of Digoxin levels, which aids in diagnosis and monitoring, but it does not directly treat or provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic test" for quantitative determination used in the "diagnosis and treatment of Digoxin overdose."
No
The device is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma, which is a chemical assay and not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states "The Randox Laboratories Digoxin Assay is an in vitro diagnostic test". This is the most direct indicator.
- Purpose: The test is for the quantitative determination of Digoxin in human serum or plasma, which are biological samples tested outside of the body.
- Clinical Application: The results are used in the diagnosis and treatment of Digoxin overdose and monitoring therapy, which are clinical applications of diagnostic testing.
The other sections being "Not Found" or "Not Applicable" do not negate the clear statement in the Intended Use that this is an in vitro diagnostic test.
N/A
Intended Use / Indications 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)
Product codes (comma separated list FDA assigned to the subject device)
KXT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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