(588 days)
Not Found
No
The description focuses on the chemical reagents and the intended use for quantitative determination of digoxin, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used for in vitro diagnostic quantitative determination of digoxin, which aids in monitoring and managing drug levels, but it does not directly treat a 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 digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy." This directly indicates its role in diagnostic processes.
No
The device description clearly outlines physical reagent packs containing chemical components (antibodies, paramagnetic particles) for an in vitro diagnostic assay, indicating it is a hardware-based system with associated reagents, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For in vitro diagnostic use". It also describes the purpose of the device as determining digoxin levels in serum and plasma, which are biological samples analyzed outside of the body.
- Device Description: The description details reagents used to perform a test on these biological samples.
- Summary of Performance Studies: The performance studies describe testing performed on biological specimens (serum and plasma) to evaluate the device's accuracy and reliability in a laboratory setting.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP systems.
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.
Product codes (comma separated list FDA assigned to the subject device)
KXT
Device Description
The ADVIA Centaur Digoxin assay reagents come in the following configurations:
5 ReadyPack primary reagent packs containing ADVIA Centaur DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master Curve card, Number of tests: 250
1 ReadyPack primary reagent pack containing ADVIA Centaur DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master Curve card, Number of tests: 50
The ReadyPack consists of the following:
ADVIA Centaur DIG ReadyPack® primary reagent pack; Lite Reagent
2.5 ml/reagent pack monoclonal mouse anti-digoxin antibody (~26.4 ng/mL) labeled with acridinium ester in protein buffered saline with sodium azide (0.11%) and preservatives.
ADVIA Centaur DIG ReadyPack primary reagent pack; Solid Phase Reagent
12.5 mL/reagent pack digitoxin (~2 ng/mL) covalently coupled to paramagnetic particles in protein buffered saline with sodium azide (0.11%) and preservatives.
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)
Specimen Equivalency: Specimen equivalency was determined with the Deming linear regression model in accordance with CLSI Document EP09-A3.
Dipotassium EDTA plasma (n=51): y = 1.02x - 0.02 ng/mL (y = 1.02x - 0.03 nmol/L); Sample Interval: 0.14–4.81 ng/mL (0.18–6.16 nmol/L); r = 0.996
Lithium heparin plasma (n=50): y = 1.06x - 0.03 ng/mL (y = 1.06x - 0.04 nmol/L); Sample Interval: 0.14–4.88 ng/mL (0.18–6.25 nmol/L); r = 0.990
Interferences: Interference testing was performed in accordance with CLSI Document EP07-ed3.
Canrenone: Tested at 1000 ng/mL, bias 2.7% at 1.11 ng/mL and -0.5% at 2.12 ng/mL.
Dipotassium EDTA: Tested at 9.0 mg/mL, bias -0.4% at 0.91 ng/mL and -1.1% at 3.12 ng/mL.
Heparin: Tested at 75 U/mL, bias 8.9% at 0.61 ng/mL and -1.7% at 3.66 ng/mL.
Potassium Canrenoate: Tested at 1000 ng/mL, bias 2.8% at 1.07 ng/mL and -1.0% at 2.08 ng/mL.
Spironolactone: Tested at 1000 ng/mL, bias 1.0% at 1.04 ng/mL and 2.5% at 2.00 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See performance studies above for regression equation, correlation coefficient, and bias.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 16, 2021
Siemens Healthcare Diagnostics, Inc. Anoop Joy Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, New York 10591
Re: K193397
Trade/Device Name: ADVIA Centaur Digoxin assay Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin Test System Regulatory Class: Class II Product Code: KXT Dated: October 16, 2020 Received: October 19, 2020
Dear Anoop Joy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193397
Device Name ADVIA Centaur® Digoxin assay
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP systems.
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness
ADVIA Centaur® Digoxin assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K193397.
l. APPLICANT
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
| Contact: | Anoop Joy |
|---|---|
| Regulatory Clinical Affairs Specialist | |
| Phone: | (914) 524-2273 |
| Fax: | (914) 524-2101 |
| E-mail: | anoop.joy@siemens-healthineers.com |
Date Prepared: July 16, 2021
Regulatory Information II.
Name of Device: ADVIA Centaur® Digoxin assay Classification: Class II Regulation Section: 21 CFR § 862.3320 Product Code: KXT Panel: Toxicology
PREDICATE DEVICE lll.
Name of Device: ADVIA Centaur® Digoxin assay 510 (k): K931213
4
DEVICE DESCRIPTION IV.
The ADVIA Centaur Digoxin assay reagents come in the following configurations:
| Contents | Number of Tests |
|---|---|
| 5 ReadyPack primary reagent packs containing ADVIA Centaur | |
| DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master | |
| Curve card | 250 |
| 1 ReadyPack primary reagent pack containing ADVIA Centaur | |
| DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master | |
| Curve card | 50 |
The ReadyPack consists of the following:
ADVIA Centaur DIG ReadyPack® primary reagent pack; Lite Reagent
2.5 ml/reagent pack monoclonal mouse anti-digoxin antibody (~26.4 ng/mL) labeled with acridinium ester in protein buffered saline with sodium azide (0.11%) and preservatives.
ADVIA Centaur DIG ReadyPack primary reagent pack; Solid Phase Reagent
12.5 mL/reagent pack digitoxin (~2 ng/mL) covalently coupled to paramagnetic particles in protein buffered saline with sodium azide (0.11%) and preservatives.
INTENDED USE >
For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP systems.
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.
INDICATIONS FOR USE VI.
Same as Intended use
COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The following table provides a comparison between the predicate and candidate device.
5
| | Predicate Device | Candidate Device
(Modified Device) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | ADVIA Centaur® Digoxin assay | ADVIA Centaur® Digoxin assay |
| Intended Use | For in vitro diagnostic use in the
quantitative determination of
digoxin in serum using the ADVIA
Centaur®, ADVIA Centaur XP,
and ADVIA Centaur XPT systems. | For in vitro diagnostic use in the
quantitative determination of
digoxin in serum and plasma
(EDTA and lithium heparin) using
the ADVIA Centaur® XP systems.
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. |
| Measurement | Quantitative | Same |
| Assay Range | 0.1–5.0 ng/mL | Same |
| Assay Principle | competitive immunoassay | Same |
| Technology | Direct chemiluminescent | Same |
| Sample Type | Serum | Serum and plasma (EDTA and
lithium heparin) |
| Sample Volume | 50 µL | same |
| Reagent
Volume | 50 µL of Lite Reagent and
250 µL of Solid Phase | same |
| Incubation
Time | Lite Reagent: 5.0 minutes at 37°C
Solid Reagent: 2.5 minutes at
37°C. | same |
| Standardization | Traceable to an internal standard
manufactured using U.S.P.
(United States Pharmacopeia)
material | Same |
| Calibration | 2-point | Same |
| Calibrators | ADVIA Centaur Calibrator B | Same |
| Number of
Calibrator
Levels | Two levels | Same |
| Controls | Commercial Controls | Same |
| Detection
Antibody | monoclonal mouse anti-digoxin
antibody labeled with acridinium
ester | Same |
| Capture
Antibody | digitoxin covalently coupled to
paramagnetic particles | Same |
Table 1: Substantial Equivalence Comparison
VIII. PERFORMANCE CHARACTERISTICS DATA
Addition of plasma sample type claim was demonstrated by performing specimen equivalency studies, precision studies and interference studies using EDTA and
6
Heparin. Since the assay principle, design or formulation has not changed from original device (K931213), the analytical performance data previously reviewed for the ADVIA Centaur® Digoxin assay continues to apply to this assay.
Specimen Equivalency
Specimen equivalency was determined with the Deming linear regression model in accordance with CLSI Document EP09-A3. The following results were obtained:
| Tube (y) vs. Serum (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|
| Dipotassium EDTA plasma | y = 1.02x - 0.02 ng/mL | |||
| (y = 1.02x - 0.03 nmol/L) | 0.14–4.81 ng/mL | |||
| (0.18–6.16 nmol/L) | 51 | 0.996 | ||
| Lithium heparin plasma | y = 1.06x - 0.03 ng/mL | |||
| (y = 1.06x - 0.04 nmol/L) | 0.14–4.88 ng/mL | |||
| (0.18–6.25 nmol/L) | 50 | 0.990 |
a Number of samples tested.
b Correlation coefficient.
Interferences
Interference testing was performed in accordance with CLSI Document EP07-ed3. The following results were obtained:
| Substance | Substance Test Concentration | Analyte Concentration
ng/mL (nmol/L) | Bias (%) |
|----------------------|------------------------------|-----------------------------------------|----------|
| Canrenone | 1000 ng/mL | 1.11 (1.42) | 2.7 |
| | | 2.12 (2.71) | -0.5 |
| Dipotassium EDTA | 9.0 mg/mL | 0.91 (1.16) | -0.4 |
| | | 3.12 (3.99) | -1.1 |
| Heparin | 75 U/mL | 0.61 (0.78) | 8.9 |
| | | 3.66 (4.68) | -1.7 |
| Potassium Canrenoate | 1000 ng/mL | 1.07 (1.37) | 2.8 |
| | | 2.08 (2.66) | -1.0 |
| Spironolactone | 1000 ng/mL | 1.04 (1.33) | 1.0 |
| | | 2.00 (2.56) | 2.5 |
X. CONCLUSION
Comparative testing of the modified ADVIA Centaur® Digoxin assay is substantially equivalent in principle and performance to the Predicate Device - ADVIA Centaur® Digoxin assay cleared under 510(k) K931213.