(49 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring digoxin levels, with no mention of AI/ML, image processing, or data-driven algorithms for interpretation or analysis beyond standard analytical methods.
No
The device is an in vitro diagnostic (IVD) device used to measure digoxin levels in human serum, which aids in diagnosis and monitoring, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the method is "for in vitro diagnostic use" and that measurements are "used as an aid in the diagnosis of digoxin overdose".
No
The device is an in vitro diagnostic (IVD) assay, which involves chemical reagents and laboratory equipment to measure a substance in a biological sample. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum."
This statement directly identifies the device's purpose as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
The Bayer ADVIA® IMS™ Digoxin assay is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
KXT
Device Description
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Imprecision
ADVIA IMS
Level (ng/mL): 0.75, Total CV(%): 6.0
Level (ng/mL): 1.9, Total CV(%): 5.9
Level (ng/mL): 3.3, Total CV(%): 3.8
Immuno 1
Level (ng/mL): 0.7, Total CV(%): 8.2
Level (ng/mL): 2.2, Total CV(%): 4.2
Level (ng/mL): 3.4, Total CV(%): 3.6
Correlation (Y= ADVIA IMS, X=comparison system)
Specimen type: Serum, Comparison System (X): Immuno 1, N: 72, Regression Equation: Y=1.017X+0.055, Syx (ng/mL): 0.265, R: 0.985, Sample Range (ng/mL): 0.04 to 4.73
Interfering Substances
Interferant: Bilirubin, Spiked Concentration (mg/dL): 25.0, Expected Concentration (ng/mL): 0.77, Observed Concentration (ng/mL): 0.80, % Deviation: 3.6
Interferant: Bilirubin, Spiked Concentration (mg/dL): 25.0, Expected Concentration (ng/mL): 2.03, Observed Concentration (ng/mL): 2.05, % Deviation: 0.7
Interferant: Bilirubin, Spiked Concentration (mg/dL): 25.0, Expected Concentration (ng/mL): 3.44, Observed Concentration (ng/mL): 3.67, % Deviation: 6.2
Interferant: Triglycerides, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 0.73, Observed Concentration (ng/mL): 0.72, % Deviation: -1.7
Interferant: Triglycerides, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 1.87, Observed Concentration (ng/mL): 1.88, % Deviation: 0.1
Interferant: Triglycerides, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 3.21, Observed Concentration (ng/mL): 3.30, % Deviation: 3.0
Interferant: Hemoglobin, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 0.67, Observed Concentration (ng/mL): 0.64, % Deviation: -4.0
Interferant: Hemoglobin, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 1.82, Observed Concentration (ng/mL): 1.71, % Deviation: -6.9
Interferant: Hemoglobin, Spiked Concentration (mg/dL): 1000.0, Expected Concentration (ng/mL): 3.18, Observed Concentration (ng/mL): 3.07, % Deviation: -3.6
Analytical Range: 0.04 - 6 ng/mL
Minimum Detectable Concentration
ADVIA IMS (ng/mL): 0.04
Immuno 1 (ng/mL): 0.04
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.
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
NOV 1 4 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Digoxin Assay for Bayer ADVIA® Integrated Modular System (IMS)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K 033 D 07
1. Intended Use
The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
2. Predicate Device
| Product Name | Reagents & Calibrators | Controls |
|---|---|---|
| Immuno 1 Digoxin Assay | K912616 | K885226 |
3. Device / Method
| Product Name |
|---|
| ADVIA IMS Digoxin Assay |
Imprecision
| ADVIA IMS | |
|---|---|
| Level | |
| (ng/mL) | Total |
| CV(%) | |
| 0.75 | 6.0 |
| 1.9 | 5.9 |
| 3.3 | 3.8 |
| Immuno 1 | |
|---|---|
| Level | |
| (ng/mL) | Total |
| CV(%) | |
| 0.7 | 8.2 |
| 2.2 | 4.2 |
| 3.4 | 3.6 |
Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (ng/mL) | R | Sample Range (ng/mL) |
|---|---|---|---|---|---|---|
| Serum | Immuno 1 | 72 | Y=1.017X+0.055 | 0.265 | 0.985 | 0.04 to 4.73 |
Interfering Substances
| Interferant | Spiked
Concentration
(mg/dL) | Expected
Concentration
(ng/mL) | Observed
Concentration
(ng/mL) | %
Deviation |
|---------------|------------------------------------|--------------------------------------|--------------------------------------|----------------|
| Bilirubin | 25.0 | 0.77 | 0.80 | 3.6 |
| Bilirubin | 25.0 | 2.03 | 2.05 | 0.7 |
| Bilirubin | 25.0 | 3.44 | 3.67 | 6.2 |
| Triglycerides | 1000.0 | 0.73 | 0.72 | -1.7 |
| Triglycerides | 1000.0 | 1.87 | 1.88 | 0.1 |
| Triglycerides | 1000.0 | 3.21 | 3.30 | 3.0 |
| Hemoglobin | 1000.0 | 0.67 | 0.64 | -4.0 |
| Hemoglobin | 1000.0 | 1.82 | 1.71 | -6.9 |
| Hemoglobin | 1000.0 | 3.18 | 3.07 | -3.6 |
1
Analytical Range
0.04 - 6 ng/mL
Minimum Detectable Concentration
| ADVIA IMS
(ng/mL) | Immuno 1
(ng/mL) |
|----------------------|---------------------|
| 0.04 | 0.04 |
Table of Similarities and Differences between IMS Digoxin and Immuno 1 Digoxin assays:
| Package Insert Sections | ADVIA IMS Digoxin assay | Bayer Immuno 1 Digoxin assay
(predicate device) |
|---------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | Similar | Similar |
| Summary | Similar | Similar |
| Principle | Heterogeneous Competitive
Magnetic Separation Assay | Heterogeneous Competitive
Magnetic Separation Assay |
| Reagents | Two liquid reagents contained in
system specific packaging | Two liquid reagents contained in
system specific packaging |
| Storage | 2-8 °C | 2-8 °C |
| Stability | Similar | Similar |
| Precautions | Similar | Similar |
| Indications of
Deterioration | Similar | Similar |
| Performance
Characteristics | Similar | Similar |
| Limitations | Similar | Similar |
| Parameters | Similar | Similar |
Clu ets tos
Kenneta T. Edds Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
9/29/03
Date
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer HealthCare 511 Benedict Avenue Tarrytown, New York 10591-5097
NOV 1 4 2003
Re: K033007
Trade/Device Name: Digoxin Assay on the Bayer ADVIA IMS® Analyzer Regulation Number: 21 CFR § 862.3320 Regulation Name: Digoxin Test System Regulatory Class: II Product Code: KXT Dated: September 26, 2003 Received: September 26, 2003
Dear Dr. Edds:
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. Iisting 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 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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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ocid 11-13-200
Page 1_of_1
510(k) Number: K033007
Device Name: Digoxin Assay for the Advia IMS
Indications for Use:
The Bayer ADVIA® IMS™ Digoxin assay is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Carol Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K033007 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | |
| OR Over-The-CounterUse |
(Optional Format 1-2-96)