(56 days)
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No
The description details a turbidimetric immunoassay technique, which is a standard chemical analysis method and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic test used to measure tobramycin levels, aiding in diagnosis and monitoring, but it does not directly treat or prevent a disease and is therefore not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test" and that its measurements are "used in the diagnosis and treatment of tobramycin overdose."
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).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test intended to measure tobramycin... in plasma and serum." This is the primary characteristic of an IVD.
- Sample Type: The device measures a substance (tobramycin) in biological samples (plasma and serum) taken from the human body. This is a key aspect of IVD testing.
- Purpose: The measurements are used "in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy." This indicates a medical purpose related to diagnosis and treatment, which is the function of an IVD.
- Device Description: The description of the method (PETINIA) confirms it's a laboratory-based test performed on samples outside the body.
The information provided clearly aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TOBR FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Product codes
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Device Description
The TOBR FLEX™ reagent cartridge is an in vitro diagnostic test designed for use on the Dimension® clinical chemistry system. It measures tobramycin in plasma and serum using the Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique, which utilizes a latex particle-tobramycin conjugate and tobramycin-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 forty-one samples were tested with the TOBR FLEX™ reagent cartridge on the Dimension® system and the aca® TOBRA test pack on the aca® discrete clinical analyzer.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
One hundred forty-one samples were tested with the TOBR FLEX™ reagent cartridge on the Dimension® system and the aca® TOBRA test pack on the aca® discrete clinical analyzer, with the following results: slope = 0.99, intercept = 0.10, correlation coefficient = 0.989, range of samples = 0-12 µg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
slope = 0.99 intercept = 0.10 correlation coefficient = 0.989 range of samples = 0-12 µg/mL
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
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§ 862.3900 Tobramycin test system.
(a)
Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "DADE" in large, bold, black letters. The font appears to be a serif typeface, with the letters evenly spaced and aligned horizontally. The background is plain white, providing a stark contrast that makes the word stand out prominently. The overall impression is clean and straightforward, emphasizing the word itself.
Image /page/0/Picture/1 description: The image shows the text "K962818" above a black rectangle with the words "DADE INTERNATIONAL" in white letters. The text "K962818" is in a handwritten style, with the letters and numbers connected. The black rectangle is located directly below the text, and the words "DADE INTERNATIONAL" are centered within the rectangle. The image appears to be a logo or trademark.
SEP 1 3 1996
Chamiciry Syc 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
Tobramycin FLEXTM Reagent Cartridge
Summary of Safety and Effectiveness
The TOBR FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
The TOBR method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-tobramycin conjugate and tobramycin-specific monoclonal antibody.
The TOBR FLEX™ reagent cartridge is substantially equivalent to the aca® tobramycin analytical test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of tobramycin in human serum or plasma.
One hundred forty-one samples were tested with the TOBR FLEX™ reagent cartridge on the Dimension® system and the aca® TOBRA test pack on the aca® discrete clinical analyzer, with the following results:
slope = 0.99 intercept = 0.10 correlation coefficient = 0.989 range of samples = 0-12 µg/mL
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
September 4, 1996
Date