← Product Code [LEG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG) · K964442 # VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964442) _Bayer Corp. · LEG · Dec 18, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K964442 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [LEG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG.md) - **Decision Date:** Dec 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3645 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K964442](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LEG/K964442) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com