(24 days)
aca® analytical test pack
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No
The summary describes a standard immunoassay technique (PETINIA) for measuring vancomycin levels. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test used to measure vancomycin levels, which is a diagnostic function, not a therapeutic one.
Yes
The text explicitly states: "The VANC FLEX™ reagent cartridge...is an in vitro diagnostic test intended to measure vancomycin...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."
No
The device is a reagent cartridge used on a clinical chemistry system, which are physical components and not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The VANC FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure vancomycin, an antibiotic drug, in plasma and serum."
N/A
Intended Use / Indications for Use
The VANC FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure vancomycin, an antibiotic drug, in plasma and 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.
Product codes
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Device Description
The VANC method is based on a Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-vancomycin conjugate and vancomycin-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
Two hundred thirty-one samples were tested with the VANC FLEX™ reagent cartridge on the Dimension® system and the aca® VANC test pack on the aca® discrete clinical analyzer, with the following results:
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two hundred thirty-one samples were tested with the VANC FLEX™ reagent cartridge on the Dimension® system and the aca® VANC test pack on the aca® discrete clinical analyzer, with the following results:
slope = 0.95 intercept = - 0.33 correlation coefficient = 0.987 range of samples = 0.1 - 49.8 ug/ mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
aca® analytical test pack
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/2 description: The image shows the text "KS63267" above a black rectangle with the words "DADE INTERNATIONAL" in white. The text "KS63267" is written in a handwritten style. The black rectangle is a solid block of color, and the white text is centered within it.
Chemistry Systems 0. Box 6101 Newark, DE 19714
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
Vancomycin FLEXTM Reagent Cartridge
Summary of Safety and Effectiveness
The VANC FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure vancomycin, an antibiotic drug, in plasma and 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.
The VANC method is based on a Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-vancomycin conjugate and vancomycinspecific monoclonal antibody.
The VANC FLEX™ reagent cartridge is substantially equivalent to the aca® analytical test pack, which was cleared by the FDA through the 510(k) process. Both tests used prepackaged reagents for the determination of vancomycin in human serum and plasma.
Two hundred thirty-one samples were tested with the VANC FLEX™ reagent cartridge on the Dimension® system and the aca® VANC test pack on the aca® discrete clinical analyzer, with the following results:
slope = 0.95 intercept = - 0.33 correlation coefficient = 0.987 range of samples = 0.1 - 49.8 ug/ mL
Carlyn K. George
arolvn K. George Regulatory Affairs and Compliance Manager
September 4, 1996
Date