(126 days)
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No
The description focuses on standard immunoassay technology and does not mention AI or ML terms.
No
The device is described as an immunoassay for the quantitative determination of procainamide, which is a diagnostic purpose, not a therapeutic one. It analyzes a substance in human samples rather than directly treating a condition.
Yes
Explanation: The device is for the "quantitative determination of procainamide in human serum or plasma," which is a measurement used to aid in diagnosis or patient management.
No
The device description explicitly states it is an "automated fluorescence polarization immunoassay (FPIA)," which is a laboratory-based hardware technology for measuring substances in biological samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of procainamide in human serum or plasma". This indicates the device is used to test biological samples (serum or plasma) outside of the body (in vitro) to provide diagnostic information (quantitative determination of a substance).
- Device Description: The description mentions "automated fluorescence polarization immunoassays (FPIA)". Immunoassays are a common technique used in IVD devices to detect and quantify specific substances in biological samples.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
the quantitative determination of procainamide 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
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: 0.98 Y-Intercept: 0.1 Correlation Coefficient: 0.989 Std. Error of the Y estimate: 0.056 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.
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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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§ 862.3320 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.
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510(k) Summary Abbott AxSYM Procainamide Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination
APR - 2 1996
The following information as presented in the Premarket Notification 510(k) for AxSYM Procainamide constitutes data supporting a substantially equivalent determination.
Substantial equivalence has been demonstrated between the AxSYM Procainamide assay and the TDx/TDxFLx Procainamide assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of procainamide 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: 0.98 Y-Intercept: 0.1 Correlation Coefficient: 0.989 Std. Error of the Y estimate: 0.056 Number: 205
The AxSYM Procainamide standard calibrators and controls are to be used with the AxSYM Procainamide 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 Procainamide 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
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