(61 days)
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No
The description details a standard immunoassay technique and automated analyzer, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) assay designed to measure digoxin levels in patient samples, which aids in monitoring therapeutic administration but does not directly administer therapy or provide treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use".
No
The device description clearly outlines a physical immunoassay kit with reagents, beads, and a process involving incubation, washing, and chemiluminescent detection, all of which are hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states, "The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use..." This is the most direct indicator.
- Measurement of Analytes in Biological Samples: The device measures the concentration of digoxin in serum or heparinized plasma, which are biological samples.
- Aid in Diagnosis or Monitoring: The intended use is described as "an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity." This falls under the scope of using the results to inform clinical decisions about a patient's treatment.
- Device Description: The description details a laboratory-based assay process involving chemical reactions and measurement of light emission, which is characteristic of in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
IMMULITE® 2000 Digoxin is a solid-phase, chemiluminescent enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer and is designed for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.
The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.
Product codes (comma separated list FDA assigned to the subject device)
KXT
Device Description
IMMULITE® 2000 Digoxin is a solid phase, chemiluminescent enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: The IMMULITE® 2000 Digoxin procedure was compared to a commercially available assay, IMMULITE® Digoxin, on 97 samples, with digoxin concentrations ranging from approximately 0.5 to 6.1 ng/mL. Linear regression analysis yielded the following statistics:
(IMMULITE 2000) = 0.94 (IMMULITE) + 0.097 ng/mL = r = 0.977
1.4 ng/mL (IMMULITE 2000) Means: 1.4 ng/mL (IMMULITE)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
SEP 1 9 2001
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name:
Address: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Facsimile Number: | (310) 645-8200
(310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.
Director, Clinical Affairs |
| Date of Preparation: | July 19, 2001 |
| Device Name:
Trade: | IMMULITE® 2000 Digoxin |
| Catalog Number: | L2KDI2 (200 tests), L2KDI6 (600 tests) |
| CFR: | A digoxin test system is 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. |
| Common: | Reagent system for the determination of digoxin in serum and
plasma. |
| Classification: | Class II device, KXT (21 CFR 862.3320) |
| Panel: | Clinical Toxicology |
| CLIA Complexity
Category: | We believe the category to be moderate, based on previous
classification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| Establishment Registration
Number: | DPC's Registration Number is 2017183 |
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Substantially Equivalent Predicate Device:
IMMULITE® Digoxin (K914833)
IMMULITE® 2000 Digoxin is a solid phase, chemiluminescent Description of Device: enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer
Intended Use of the Device:
IMMULITE® 2000 Digoxin is a solid-phase, chemiluminescent enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer and is designed for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.
Technology:
IMMULITE® 2000 Digoxin is a solid-phase, chemiluminescent enzyme-labeled immunoassay The solid phase is a polystyrene bead coated with a monoclonal murine anti-digoxin antibody.
The patient sample and alkaline phosphatase-conjugated digoxin are simultaneously introduced introduced introduced introduced introduced introduced into the Reaction Tube containing the bead, and incubated for approximately 30 minutes at 37 ( ... intermittent agitation. During this time, digoxin in the sample competes with the enzyme-fairched digoxin for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Reaction Tube is incubated for a further 5 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision bv providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of digoxin in the sample
IMMULITE® Digoxin is a solid-phase, chemiluminescent enzyme-labeled immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal murine anti-digoxin antibody.
The patient sample and alkaline phosphatase-conjugated digoxin are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, digoxin in the sample competes with the enzyme-labeled digoxin for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed ? centrifugal wash, after which substrate is added and the Test Unit is incubated for a further . minutes.
2
Technology (continued):
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis !!! the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of digoxin in the sample.
Performance Equivalence:
Diagnostic Products Corporation asserts that IMMULITE® 2000 Digoxin produce substantialin equivalent results to other commercially marketed digoxin assays, such as IMMULITE® Digoxin
Method Comparison:
The IMMULITE® 2000 Digoxin procedure was compared to a commercially available assay, IMMULITE® Digoxin, on 97 samples, with digoxin concentrations ranging from approximately 0.5 to 6.1 ng/mL. Linear regression analysis yielded the following statistics:
(IMMULITE 2000) = 0.94 (IMMULITE) + 0.097 ng/mL = r = 0.977
1.4 ng/mL (IMMULITE 2000) Means: 1.4 ng/mL (IMMULITE)
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® 2000 Digoxin.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
SEP 1 9 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director, Clinical Affairs Diagnostic Products Corporations 5700 West 96th Street Los Angeles, CA 90045-5597
Re: K012301
Trade/Device Name: Immulite® 2000 Digoxin Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: KXT Dated: July 19, 2001 Received: July 20, 2001
Dear Dr. Levine:
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 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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): K012301 Device Name: IMMULITE® 2000 Digoxin
Indications For Use: The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander for Jean Cuypers
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012301
[X]
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)