(189 days)
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No
The description details a standard immunoassay method based on competitive binding and agglutination, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic immunoassay that measures digitoxin levels in serum, which is used for diagnosis and monitoring, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that measurements obtained by this device are "used in the diagnosis and treatment of digitoxin in the serum."
No
The device description clearly outlines a chemical immunoassay process involving physical reagents (measuring particles, antibody) and a measurement of light changes due to agglutination, indicating a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic immunoassay" and is used for the "quantitative determination of digitoxin in serum." It also mentions its use in "diagnosis and treatment" and "monitoring levels," which are typical applications for IVDs.
- Device Description: The description details a laboratory test method that analyzes a biological sample (serum) outside of the body ("in vitro").
- Anatomical Site: The sample is taken from "Serum," which is a biological fluid analyzed in a laboratory setting.
- Intended User / Care Setting: The device is intended for "suitably qualified laboratory personnel under appropriate laboratory conditions," indicating a laboratory-based diagnostic test.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic 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 therapeutic concentrations.
Product codes (comma separated list FDA assigned to the subject device)
LFM
Device Description
The method is based on measuring changes in absorbance as a result of binding. The reagent particles are coated with enzyme comple concentration process. The respective and and the aggituredion 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 inge in scattered light as a change in absorbance, proportional le sample.
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
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Intended User / Care Setting
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.
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
§ 862.3300 Digitoxin test system.
(a)
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.(b)
Classification. Class II.
0
JAN 1 1 2002
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 stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
- 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
1
Page 2 -
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, (301) 594-4588. Additionally, for questions of (301) 594-4639. 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 (800) 638-2041 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".
(301) 443-6597 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
2
k) Number (if known): -
DIGITOXIN
-Not Known
ce Name:
ications For Use :
Jostion's POI USC 1 s Francox Laboratories Ltd. Digitoxin Test Kit is an in viro olaghostio nhagoed
intilative determination of digitoxin in serum. The method in scedes in scene ് intelled determination of digitoxin of measuring changes in sociolosin and only only സ്ഥിതിനിമ്പ് മടങ്ങും വേടിയ വിവ്യ സംസ്ഥ നിന്നും വിവർഗ്വന്തവാക്കി വേണ്ടിന്റെ വേണ്ടിന്റെ വിശ്വാസവന്ത്രി സ്ഥാനം
പ്രവേന്ദ്രിക്കോ രാമ്പേഴ വേറ്റിസ് വർത്തിച്ച വേട്ടി വിട്ട വേട്ടി വ in saides are coated with drime comple continue ation process. The respective and and the of aggituredion
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
inge in scattered light as a change in absorbance, proportional le sample.
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)
| Jean Cooper | |
|---|---|
| (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) |