Advia Ims Valproic Acid Method
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042807 FDA 510(k)
- FDA Product Code
- LEG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3645 FDA 510(k)
- Regulation Number
- 862.3645 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advia Ims Valproic Acid Method is an in vitro diagnostic device used to measure the antiepileptic drug valproic acid in human serum and plasma. It is an enzyme immunoassay that provides quantitative measurements of valproic acid (2-propylpentanoic acid) to aid in the diagnosis and treatment of valproic acid overdose.
This device is for single-use in vitro diagnostic applications and is supplied as part of the ADVIA® IMS systems. It is a Class 2 Chemistry device (product code LEG) that received FDA 510(k) clearance through the Traditional pathway on February 8, 2005, after a 119-day review.
Frequently asked questions
What is the Advia Valproic Acid Method used for?
The Advia Valproic Acid Method is used to measure the antiepileptic drug valproic acid in human serum and plasma to aid in the diagnosis and treatment of valproic acid overdose.
Is the Advia Valproic Acid Method for single-use or reuse?
The Advia Valproic Acid Method is for single-use in vitro diagnostic applications.
How is the Advia Valproic Acid Method supplied?
The Advia Valproic Acid Method is supplied as part of the ADVIA IMS systems.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ADVIA IMS VALPROIC ACID METHOD (K042807) — FDA 510 (k) | Innolitics, K042807 - ADVIA IMS VALPROIC ACID METHOD | FDA 510 (k), PDF A cid - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042807 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K042807 24 fields · synced Sep 26, 2026