(148 days)
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No
The summary describes a standard immunoassay technology (FPIA) and does not mention AI, ML, or any related concepts. The performance studies are based on correlation, not typical AI/ML metrics.
No
The device is for the "quantitative determination of N-acetylprocainamide", indicating a diagnostic purpose rather than a therapeutic one.
Yes
The device is described as for the "quantitative determination of N-acetylprocainamide in human serum or plasma," which indicates it measures a substance in the body for diagnostic purposes (e.g., monitoring drug levels or detecting abnormalities). This is further supported by the mention of a "TDx/TDxFLx N-Acetylprocainamide assay" as a predicate device, which is an established diagnostic test.
No
The device description explicitly states "automated fluorescence polarization immunoassays (FPIA)," which are hardware-based laboratory instruments used for quantitative analysis. The summary does not mention any software-only components or functions.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of Nacetylprocainamide in human serum or plasma". This involves testing biological samples (serum or plasma) outside of the body (in vitro) to diagnose or monitor a condition (determining the level of Nacetylprocainamide).
- Device Description: The device is described as an "automated fluorescence polarization immunoassays (FPIA)". Immunoassays are a common type of test used in IVD devices to detect or measure specific substances in biological samples.
These characteristics 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 Nacetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Both assays are automated fluorescence polarization immunoassays (FPIA).
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: 1.05 Y-Intercept: -0.1 Correlation Coefficient: 0.993 Std. Error of the Y estimate: 0.081 Number: 205
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.
TDx/TDxFLx N-Acetylprocainamide assay
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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§ 862.3320 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
K9554aa
APR 2 4 1996
510(k) Summary Abott AxSYM N-Acetylprocainamide
Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination
The following information as presented in the Premarket Notification 510(k) N-Acetylprocainamide constitutes data supporting a substantially for AxSYM equivalent determination.
Substantial equivalence has been demonstrated between the AxSYM N-Acetylprocainamide assay and the TDx/TDxFLx N-Acetylprocainamide assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of Nacetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate). Both assays are calibrated with Abbott calibrators. Abbott controls are assayed controls used for verification of the accuracy and precision of the AxSYM system. Correlation studies indicated the following results:
Slope: 1.05 Y-Intercept: -0.1 Correlation Coefficient: 0.993 Std. Error of the Y estimate: 0.081 Number: 205
The AxSYM N-Acetylprocainamide standard calibrators and controls are to be used with the AxSYM N-Acetylprocainamide reagents. The calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources. The calibrators and controls are verified using protocols involving multiple instrument testing. AxSYM N-Acetylprocainamide reagent, calibrator and control expiration dates are based on real time stability testing.
Prepared and Submitted :
Grace LeMieux (708) 937-0165 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537