(46 days)
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No
The summary describes a standard immunoassay technology (FPIA) and does not mention any AI/ML terms or concepts.
No.
This device is described as an immunoassay for the quantitative determination of digitoxin, which is a diagnostic function, not a therapeutic one.
Yes
The device is used for the "quantitative determination of digitoxin in human serum or plasma," which is a diagnostic measurement. It also refers to "immunoassays" and "correlation studies," which are characteristic of diagnostic devices.
No
The device description explicitly states "automated fluorescence polarization immunoassays (FPIA)," which is a laboratory-based hardware technology, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of digitoxin in human serum or plasma". This indicates the device is used to test samples taken from the human body (in vitro) to diagnose or monitor a condition (determining the level of digitoxin).
- Device Description: The description mentions "automated fluorescence polarization immunoassays (FPIA)". Immunoassays are a common method used in IVD testing to detect and measure specific substances in biological samples.
- Sample Type: The device is designed to analyze "human serum or plasma", which are biological samples commonly used in IVD testing.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Abbott AxSYM Digitoxin assay is substantially equivalence to the TDx/TDxFLx Digitoxin assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The AxSYM Digitoxin standard calibrators and controls are to be used with the AxSYM Digitoxin reagents. The calibrators and controls are prepared gravimetrically using purfied material obtained from commercial sources. The calibrators and controls are verified using protocols involving multiple instrument testing. AxSYM Digitoxin reagent, calibrator and control expiration dates are based on real time stability testing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation studies indicated the following results: Slope: 0.96 Y-intercept: 0.58 Correlation Coefficient: 0.97 Std. Error of the Y estimate: 1.87 Number: 517
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.
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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.
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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).
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§ 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
K963/58
SEP 1 0 1996
510(k) Summary Abbott AxSYM® Digitoxin
Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination
The Abbott AxSYM Digitoxin assay is substantially equivalence to the TDx/TDxFLx Digitoxin assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate). Both assays are calibrated with Abbott calibrators. Abbott controls are used for verification of accuracy and precision of the AxSYM system when used for the quantitative determination of digitoxin in human serum or plasma. Correlation studies indicated the following results:
Slope: 0.96 Y-intercept: 0.58 Correlation Coefficient: 0.97 Std. Error of the Y estimate: 1.87 Number: 517
The AxSYM Digitoxin standard calibrators and controls are to be used with the AxSYM Digitoxin reagents. The calibrators and controls are prepared gravimetrically using purfied material obtained from commercial sources. The calibrators and controls are verified using protocols involving multiple instrument testing. AxSYM Digitoxin reagent, calibrator and control expiration dates are based on real time stability testing.
Prepared and Submitted:
Grace LeMieux (847) 937-0165 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537