(42 days)
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No
The summary describes a quantitative immunoassay for measuring valproic acid levels, which is a standard laboratory technique and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) method used to measure valproic acid levels, which aids in monitoring and diagnosis rather than directly treating a condition.
Yes
The "Intended Use" section explicitly states that "Measurements of valproic acid are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy." This indicates its role in aiding medical diagnosis.
No
The device is an in vitro diagnostic (IVD) assay that measures valproic acid in human serum or plasma using a specific assay kit and a Technicon Immuno-1 system. This involves chemical reagents and a physical instrument, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is an "in vitro method" and is used to measure a substance (valproic acid) in human serum or plasma. This is a key characteristic of an IVD.
- Sample Type: It uses human serum or plasma, which are biological samples analyzed outside of the body.
- Purpose: The measurements are used in the "diagnosis and treatment" of valproic acid overdose and "monitoring levels" for therapy. This directly relates to providing information for medical decisions, which is the purpose of IVDs.
- Device Name: The name "Syva EMIT Valproic Acid Assay" and the mention of it being used on a "Technicon Immuno-1 system" further indicate it's a laboratory-based diagnostic test.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure valproic acid, an anticonvulsant drug, in human serum or plasma (heparin) using Syva EMIT Valproic Acid Assay on a Technicon Immuno-1 system. Measurements of valproic acid are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid 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 Valproic Acid method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Valproic Acid Assay, Behring Diagnostics Inc.).
| METHOD | Immuno 1 Valproic Acid Method Set | Syva EMIT® Valproic Acid Assay (predicate Device) |
|---|---|---|
| Part No. | T01-3698-01 | 6G009UL |
| Minimum Detectable Conc. | 0.9 µg/mL | Not listed |
| Precision (Between-Run) | 3.4% @ 50.4 µg/mL; 2.6% @ 115.4 µg/mL; 2.9% @ 132.2 µg/mL | 4.6% @ 76 µg/mL |
| Correlation | y = 0.94x - 0.22 where y = Immuno 1 Valproic Acid method x = Syva EMIT® Valproic Acid Assay* n = 50 r = 0.996 Syx = 3.16 µg/mL | No value listed |
*This assay was performed on COBAS FARA II Instrument using parameters and protocol specified in Behring Application Sheet.
Key Metrics
Minimum Detectable Conc.: 0.9 µg/mL
Precision (Between-Run): 3.4% @ 50.4 µg/mL; 2.6% @ 115.4 µg/mL; 2.9% @ 132.2 µg/mL
Correlation: y = 0.94x - 0.22, n = 50, r = 0.996, Syx = 3.16 µg/mL
Predicate Device(s)
Syva EMIT® Valproic Acid Assay, Behring Diagnostics Inc.
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 1 8 1996
Valproic Acid Method for Bayer Technicon Immuno 1° System
Listed below is a comparison of the performance between the Immuno 1 Valproic Acid method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Valproic Acid Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Valproic Acid method sheet and the Syva EMIT® Valproic Acid Assay Insert Sheet.
INTENDED USED
This in vitro method is intended to quantitatively measure valproic acid, an anticonvulsant drug, in human serum or plasma (heparin) using Syva EMIT Valproic Acid Assay on a Technicon Immuno-1 system. Measurements of valproic acid are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
| METHOD | Immuno 1 Valproic Acid Method Set | Syva EMIT® Valproic Acid Assay
(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Part No. | T01-3698-01 | 6G009UL |
| Minimum Detectable Conc. | 0.9 µg/mL | Not listed |
| Precision (Between-Run) | 3.4% @ 50.4 µg/mL
2.6% @ 115.4 µg/mL
2.9% @ 132.2 µg/mL | 4.6% @ 76 µg/mL |
| Correlation | y = 0.94x - 0.22
where
y = Immuno 1 Valproic Acid method
x = Syva EMIT® Valproic Acid Assay*
n = 50
r = 0.996
Syx = 3.16 µg/mL | |
*This assay was performed on COBAS FARA II Instrument using parameters and protocol specified in Behring Application Sheet.
Gabriel J. Munoz Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
11/5/96
Date