(56 days)
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Abbott AxSYM®, Dimension® clinical chemistry system
No
The description details a turbidimetric immunoassay technique, which is a standard chemical analysis method and does not mention or imply the use of AI or ML.
No.
The device is an in vitro diagnostic test for measuring gentamicin levels to aid in diagnosis and monitoring, not for providing direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test intended to measure gentamicin...in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy." This clearly defines it as a diagnostic device.
No
The device is described as a "reagent cartridge" used on a "clinical chemistry system," indicating it is a physical component (reagent) and relies on a hardware system (Dimension® clinical chemistry system). It is an in vitro diagnostic test, which typically involves physical reagents and instrumentation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test intended to measure gentamicin... in human specimens." It also mentions its use in "diagnosis and treatment" and "monitoring levels," which are typical applications for IVDs.
- Device Description: The description of the method (PETINIA) and the components (reagent cartridge, clinical chemistry system) are consistent with an in vitro diagnostic assay.
- Performance Studies: The inclusion of performance studies comparing it to a predicate device (Abbott AxSYM® Gentamicin assay) is a standard requirement for demonstrating the performance of an IVD.
The information provided clearly indicates that this device is designed to be used outside of the body to examine specimens from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
Product codes
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Device Description
The GENT method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody.
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
One hundred ninety-семь samples were tested with the GENT FLEX™ reagent cartridge on the Dimension® system and the Abbott Gentamicin assay on the Abbott AxSYM®, with the following results:
Summary of Performance Studies
study type: comparison, sample size: 197, key results: slope = 1.02 intercept = - 0.15 correlation coefficient = 0.987 range of samples = 0.1-10.6 µg/mL
Key Metrics
correlation coefficient = 0.987
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the text "K962819" above the words "DADE INTERNATIONAL". The text is in black and the background is white. The font is bold and sans-serif.
Chemistry Systems P (). Box 6101 Newark DE 19714
SEP 1 3 1996
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
Gentamicin FLEX™ Reagent Cartridge
Summary of Safety and Effectiveness
The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
The GENT method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody.
The GENT FLEX™ reagent cartridge is substantially equivalent to the Abbott AxSYM® Gentamicin assay, which was cleared by the FDA through the 510(k) process. Both tests use liquid reagents in an automated system for the determination of gentamicin in human serum or plasma.
One hundred ninety-seven samples were tested with the GENT FLEX™ reagent cartridge on the Dimension® system and the Abbott Gentamicin assay on the Abbott AxSYM®, with the following results:
slope = 1.02 intercept = - 0.15 correlation coefficient = 0.987 range of samples = 0.1-10.6 µg/mL
AxSYM® is a registered trademark of Abbott Laboratories, Abbott Park, IL 60064.
Carolyn K. Henge
Regulatory Affairs and Compliance Manager
September 4, 1996
Date
Printed on recycled paper
with 25% post consumer