(134 days)
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No
The summary describes a fluorescence polarization immunoassay (FPIA) for quantitative determination of vancomycin. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No.
This device is for the quantitative determination of vancomycin in human serum or plasma, which is a diagnostic purpose, not a therapeutic one. Therapeutic devices are designed to treat or alleviate a disease or condition.
Yes
Explanation: The device is intended for the "quantitative determination of vancomycin in human serum or plasma," which is a measurement used to aid in the diagnosis and monitoring of a patient's condition. While not explicitly stating "diagnosis," quantitative determination of substances in bodily fluids is a fundamental aspect of diagnostic testing.
No
The device description explicitly states "automated fluorescence polarization immunoassays (FPIA)," which is a hardware-based laboratory technique. The summary does not mention any software components or functions.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of vancomycin in human serum or plasma...". This clearly indicates the device is used to test biological samples (serum or plasma) in vitro (outside the body) to diagnose or monitor a condition (vancomycin levels).
- Device Description: The description mentions "automated fluorescence polarization immunoassays (FPIA)". Immunoassays are a common technique used in IVD devices to measure the presence or amount of specific substances in biological samples.
- Sample Type: The device is designed to analyze "human serum or plasma", which are biological specimens.
The other sections, while providing details about the device and its performance, do not contradict or negate its classification as an IVD. The lack of information on image processing, AI, anatomical site, etc., is not relevant to the core definition of an IVD.
N/A
Intended Use / Indications for Use
The intended use of both assays is for the quantitative determination of vancomycin 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: 1.03 Y-Intercept: -1.08 Correlation Coefficient: 0.99 Std. Error of the Y estimate: 2.74 Number: 217
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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§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
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510(k) Summary Abbott AxSYM® Vancomycin II
MAY - 9 1996
6
Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination
The following information as presented in the Premarket Notification 510(k) for AxSYM Vancomycin II constitutes data supporting a substantially equivalent determination.
Substantial equivalence has been demonstrated between the AxSYM Vancomycin II assay and the AxSYM Vancomycin assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of vancomycin in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate). Both assays are calibrated with Abbott calibrators. Abbott controls are used for verification of the accuracy and precision of the AxSYM system. Correlation studies indicated the following results:
Slope: 1.03 Y-Intercept: -1.08 Correlation Coefficient: 0.99 Std. Error of the Y estimate: 2.74 Number: 217
The AxSYM Vancomycin II standard calibrators and controls are to be used with the AxSYM Vancomycin II 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 Vancomycin II 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