VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K964442 · Bayer Corp. · LEG · Dec 18, 1996 · Clinical Toxicology

Device Facts

• Record ID: K964442
• Device Name: VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended 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.

Device Story

In vitro diagnostic assay; measures valproic acid concentrations in human serum/plasma; used on Technicon Immuno-1® system. Clinical utility: monitoring therapeutic drug levels; diagnosing overdose. Output: quantitative concentration (µg/mL). Used in clinical laboratory settings by trained personnel. Results assist clinicians in adjusting drug dosage or managing toxicity.

Clinical Evidence

Bench testing only. Method comparison study (n=50) against Syva EMIT® Valproic Acid Assay on COBAS FARA II® instrument. Correlation: y = 0.94x - 0.22; r = 0.996; S_yx = 3.16 µg/mL. Precision (between-run) reported at 2.6%–3.4% across concentrations 50.4–132.2 µg/mL.

Technological Characteristics

In vitro diagnostic immunoassay. Quantitative measurement via Technicon Immuno-1® system. Minimum detectable concentration: 0.9 µg/mL.

Indications for Use

Indicated for quantitative measurement of valproic acid in human serum or plasma for patients undergoing anticonvulsant therapy or suspected of valproic acid overdose.

Regulatory Classification

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.

Predicate Devices

• Syva EMIT® Valproic Acid Assay (Behring Diagnostics Inc.)

Reference Devices

• COBAS FARA II® Instrument

Submission Summary (Full Text)

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K964442

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Valproic Acid Method for Bayer Technicon Immuno 1® System

DEC 18 1996

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
S_{yx} = 3.16 µg/mL

*This assay was performed on COBAS FARA II® Instrument using parameters and protocol specified in Behring Application Sheet. | |

Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
Bayer Corporation
511 Benedict Avenue
Tarrytown, New York 10591-5097

Date
11/5/96