(153 days)
K94615, K011035
Not Found
No
The device description details a homogeneous, sequential, chemiluminescent immunoassay based on LOCI® technology, which is a standard laboratory technique. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance metrics.
No.
The device is an in vitro diagnostic test used for quantitative measurement of digoxin in human serum and plasma to monitor drug levels and diagnose overdose, not directly for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma" and that "Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy." This directly identifies the device as a diagnostic tool.
No
The device is an in vitro diagnostic test that includes physical reagents (beads, antibodies, calibrators) and is used on a specific hardware system (Dimension Vista® System). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states: "The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma..." and "The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method..." This directly identifies the device and its calibrator as IVDs.
- Device Description: The description details a method for analyzing human serum and plasma samples using a chemical reaction (chemiluminescent immunoassay) to measure a substance (digoxin) within those samples. This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The document includes performance studies (method comparisons and reproducibility testing) that are typical for evaluating the accuracy and reliability of an IVD device.
- Predicate Device(s): The mention of predicate devices with K numbers indicates that this device is being compared to previously cleared IVD devices.
All of these points strongly support the conclusion that this device is an In Vitro Diagnostic.
N/A
Intensive Use / Indications for Use
The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma on the Dimension Vista" System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
KXT, JIX, DLJ
Device Description
Method: The DIGXN method is a homogeneous, sequential, chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated F(ab')2 fragment of an anti-Digoxin mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with ouabain, a weaker binding analog of digoxin, and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated F(ab')> which allows digoxin from the sample to saturate a fraction of the biotinylated F(ab')2 that is directly related to the digoxin concentration. In a second step, ouabain chemibeads are added and form bead/biotinylated F(ab')> immunocomplexes with the non-saturated fraction of the biotinylated F(ab')>. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemilyminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the digoxin concentration in the sample.
Calibrator: The DRUG 4 Calibrator is a 5 level, liquid calibrator. It is packaged as a kit of ten vials, two vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is human serum.
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)
Split sample method comparisons demonstrated equivalence between the Dimension Vista® DIGXN Flex® reagent cartridge assay and the Dimension® DGNA Flex® reagent cartridge assay.
Reproducibility testing was done in accordance with CLSI Guideline EP5-A2: Evaluation of Precision Performance of Clinical Chemistry Devices. For each test level, single tests from two independent cups were analyzed twice a day, for 20 days. The repeatability and within lab precision standard deviations (SD) and percent coefficient of variation (% CV) were calculated by the analysis of variance method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 1.02
Intercept: -0.04 ng/mL
Correlation Coefficient (r): 0.98
Sample size (n): 116
Repeatability SD: Level 1 QC - 0.01, Level 2 QC - 0.02, Level 3 QC - 0.05, Level 1 serum pool - 0.01, Level 2 serum pool - 0.03
Repeatability %CV: Level 1 QC - 1.5, Level 2 QC - 1.2, Level 3 QC - 1.4, Level 1 serum pool - 1.5, Level 2 serum pool - 1.3
Within Lab SD: Level 1 QC - 0.01, Level 2 QC - 0.02, Level 3 QC - 0.05, Level 1 serum pool - 0.02, Level 2 serum pool - 0.03
Within Lab %CV: Level 1 QC - 1.7, Level 2 QC - 1.4, Level 3 QC - 1.5, Level 1 serum pool - 1.7, Level 2 serum pool - 1.4
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.
K94615, K011035
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
510(k) Summary of Safety and Effectiveness for the Dimension Vista® LOCI Digoxin Flex® Reagent Cartridge (K6435) and Dimension Vista® DRUG 4 Calibrator (KC460)
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.
A. 510(k) Number: K093441
B. Date of Preparation: October 30, 2009
C. Proprietary and Established Names:
Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435) Dimension Vista® DRUG 4 Calibrator, DRUG 4 CAL (KC460)
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Frances A. Dillon, Regulatory Affairs & Compliance Manager Office: (302) 631-6951 Fax: (302) 631-6299
E. Requlatory Information:
Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435)
-
- Regulation section: 21 CFR § 862.3320 Digoxin test system
-
- Classification: Class II
-
- Product Code: KXT
-
- Panel: Toxicology
Dimension Vista® DRUG 4 Calibrator, DRUG 4 CAL (KC460)
-
- Requlation section: 21 CFR § 862.1150 calibrator, multi-analyte mixture
-
- Classification: Class II
-
- Product Code: JIX
-
- Panel: Clinical Chemistry
F. Predicate Device:
Method
Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435), is substantially equivalent to the Dimension® Digoxin Flex® reagent cartridge, DGNA (DF35A), cleared under K94615.
Calibrator
Dimension Vista® DRUG 4 Calibrator, DRUG 4 CAL (KC460), is substantially equivalent to Dimension® Drug Calibrator, DRUG CAL (DC22B), cleared under K011035.
G. Device Description:
Method
The DIGXN method is a homogeneous, sequential, chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated F(ab')2 fragment of an anti-Digoxin mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with ouabain, a weaker binding analog of digoxin, and contains a photosensitizer dye. In a first step, sample
1
is incubated with biotinylated F(ab')> which allows digoxin from the sample to saturate a fraction of the biotinylated F(ab')2 that is directly related to the digoxin concentration. In a second step, ouabain chemibeads are added and form bead/biotinylated F(ab')> immunocomplexes with the non-saturated fraction of the biotinylated F(ab')>. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemilyminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the digoxin concentration in the sample.
Calibrator
The DRUG 4 Calibrator is a 5 level, liquid calibrator. It is packaged as a kit of ten vials, two vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is human serum.
H. Intended Use:
Method
The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma on the Dimension Vista" System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
Calibrator
The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.
I. Substantial Equivalence Information:
The Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435) and the Dimension Vista® DRUG 4 Calibrator, DRUG 4 CAL (KC460) were compared to the respective predicate devices, Dimension® Digoxin Flex® reagent cartridge, DGNA (DF35A), cleared under K94615 and Dimension® Drug Calibrator, DRUG CAL (DC22B), cleared under K011035. A comparison of the important similarities and differences between the devices is provided in the following tables:
Method
Similarities
| Feature | Dimension Vista® LOCI DIGXN
Flex® reagent cartridge (K6435) | Predicate
Dimension® DGNA Flex®
reagent cartridge (DF35A) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The DIGXN method is an in vitro
diagnostic test for the quantitative
measurement of digoxin in human
serum and plasma on the
Dimension Vista® System.
Measurements of digoxin are used
in the diagnosis and treatment of
digoxin overdose and in monitoring
levels of digoxin to help ensure
appropriate therapy. | The DGNA method used on the
Dimension® clinical chemistry
system is an in vitro diagnostic
test intended to measure digoxin,
a cardiovascular drug, in human
serum and plasma. DGNA test
results are used in the diagnosis
and treatment of digoxin
overdose and in monitoring levels
of digoxin to ensure appropriate
therapy. |
2
| Sample
| Types | Serum and plasma | Serum and plasma |
|---|---|---|
| Measuring | ||
| Range | Trade Name: Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435) and Dimension Vista® Drug 4 Calibrator, DRUG 4 CAL (KC460) Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Codes: KXT. DLJ Dated: February 18, 2010 Received: February 22, 2010 |
Dear Ms. Dillon:
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 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).
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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 Vitro 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications For Use
510(k) Number (if known): K093441
Device Name:
Dimension Vista® LOCI Digoxin Flex® reagent cartridge, DIGXN (K6435)
Indications for Use:
The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma on the Dimension Vista® System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
Prescription Use and/or (Part 21 CFR 801 Subpart D)
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
d===========================================================================================================================================================================
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093441
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Indications For Use
510(k) Number: K093441
Device Name:
Dimension Vista® Drug 4 Calibrator, DRUG 4 CAL (KC460)
Indications for Use:
The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.
Prescription Use ج and/or (Part 21 CFR 801 Subpart D)
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) �����������������������������������������������������������������������������������������������������������������������������������������������������������������������������
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K093441
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