(64 days)
Syva EMIT® 2000 Carbanazepine Assay
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No
The summary describes a quantitative immunoassay for measuring drug levels, which is a standard laboratory technique and does not mention any AI/ML components.
No
The device is used to measure carbamazepine drug levels, aiding in diagnosis and monitoring therapy, but it does not directly provide therapeutic intervention itself.
Yes
The intended use explicitly states that "Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose".
No
The device description is not available, but the intended use and performance studies clearly indicate a laboratory assay performed on a physical instrument (Technicon Immuno-1 system) using reagents (Syva EMIT 2000 Assay). This involves hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "This in vitro method is intended to quantitatively measure carbamazepine drug, in human serum or plasma...". The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes "human serum or plasma," which are biological samples taken from the body, a common characteristic of IVDs.
- Purpose: The measurements are used "in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions, which is the core function of an IVD.
- Assay Method: The use of a "Syva EMIT 2000 Assay" on a "Technicon Immuno-1 system" describes a laboratory-based assay method, typical of IVDs.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.
Product codes
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Device Description
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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
Listed below is a comparison of the performance between the Immuno 1 Carbamazepine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Carbanazepine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Carbanazepine method sheet and the Syva EMIT® 2000 Carbamazepine Assay insert.
Key Metrics
Minimum Detectable Conc. (Immuno 1 Carbamazepine): 0.2 µg/mL
Minimum Detectable Conc. (Syva EMIT® 2000): 0.5 µg/mL
Precision (Between-Run) (Immuno 1 Carbamazepine): 2.8 µg/mL 3.9%; 9.6 µg/mL 4.2%; 16.1 µg/mL 8.7%
Precision (Between-Run) (Syva EMIT® 2000): 4.0 µg/mL 7.3%; 10.0 µg/mL 5.9%; 16.3 µg/mL 5.6%
Correlation: y=1.07x-0.13, where y = Immuno 1 Carbamazepine method, x = Syva EMIT® 2000 Carbamazepine Assay*, n = 50, r =0.978, Syx =0.89 µg/mL
Predicate Device(s)
Syva EMIT® 2000 Carbanazepine Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
13,1996
SUMMARY OF SAFETY AND EFFECTIVENTAS
Carbamazepine Method for Bayer Technicon Immune 1 System
Listed below is a comparison of the performance between the Immuno 1 Carbamazepine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Carbanazepine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Carbanazepine method sheet and the Syva EMIT® 2000 Carbamazepine Assay insert.
INTENDED USED
This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.
| METHOD | Immuno 1 Carbamazepine | Syva EMIT® 2000
(predicate Device) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Part No. | Reagents T01-3677-51
Calibrators T03-3679-01 | Reagents 4F019UL
Calibrators 4F109UL |
| Minimum Detectable Conc. | 0.2 µg/mL | 0.5 µg/mL |
| Precision (Between-Run) | 2.8 µg/mL 3.9%
9.6 µg/mL 4.2%
16.1 µg/mL 8.7% | 4.0 µg/mL 7.3%
10.0 µg/mL 5.9%
16.3 µg/mL 5.6% |
| Correlation | y=1.07x-0.13 | |
| | where
y = Immuno 1 Carbamazepine method
x = Syva EMIT® 2000 Carbamazepine Assay*
n = 50
r =0.978
Syx =0.89 µg/mL | |
*This assay was performed on Roche COBAS FARA II® Instrument.
Gabriel J. Murada, Jr.
Manager Regulatory Affairs Baver Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/7/96
Date