(56 days)
aca® carbamazepine analytical test pack
aca® CRBAM test pack
No
The document describes a standard in vitro diagnostic immunoassay based on a well-established technique (FETINIA) and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test for measuring carbamazepine levels, which is a diagnostic function, not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "an in vitro diagnostic test intended to measure carbamazepine... Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose".
No
The device is described as a "reagent cartridge" and utilizes a "Particle Enhanced Turbidimetric Inhibition Immunoassay (FETINIA) technique," which are physical components and chemical processes, not solely software.
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 carbamazepine... in plasma or serum." It also mentions its use in "diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy." These are clear diagnostic purposes.
- Device Description: The description reiterates that it is an "in vitro diagnostic test" and describes the method used to measure the substance in a biological sample (plasma or serum).
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, from the human body to help diagnose diseases or conditions. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
Product codes
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Device Description
The CRBM method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (FETINIA) technique which uses a latex particle-carbamazepine conjugate and carbamazepine-specific monoclonal antibody.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
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
Eighty-two samples were tested with the CRBM FLEX™ reagent cartridge on the Dimension® system and the aca® CRBAM test pack on the aca® discrete clinical analyzer, with the following results: slope = 0.99 intercept = 0.06 correlation coefficient = 0.979 range of samples = 0-18.6 µg/mL
Key Metrics
slope = 0.99 intercept = 0.06 correlation coefficient = 0.979 range of samples = 0-18.6 µg/mL
Predicate Device(s)
aca® carbamazepine analytical test pack
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
SEP 1 3 1996
Image /page/0/Picture/2 description: The image shows the text "K962820" in a handwritten style above the words "DADE INTERNATIONAL" in a bold, sans-serif font. The words "DADE INTERNATIONAL" are set against a solid black rectangular background. The handwritten text appears to be a code or identifier, while the text below indicates an organization or company name.
Chemistry Systems P.O. 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
Carbamazepine FLEX™ Reagent Cartridge
Summary of Safety and Effectiveness
The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
The CRBM method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (FETINIA) technique which uses a latex particle-carbamazepine conjugate and carbamazepinespecific monoclonal antibody.
The CRBM FLEX™ reagent cartridge is substantially equivalent to the aca® carbamazepine analytical test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of carbamazepine in human serum and plasma.
Eighty-two samples were tested with the CRBM FLEX™ reagent cartridge on the Dimension® system and the aca® CRBAM test pack on the aca® discrete clinical analyzer, with the following results:
slope = 0.99 intercept = 0.06 correlation coefficient = 0.979 range of samples = 0-18.6 µg/mL
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
September 4, 1996
Date
i late