Identifiers
- 510(k) Number
- K880705 FDA 510(k)
- FDA Product Code
- DKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3200 FDA 510(k)
- Regulation Number
- 862.3200 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Calibrator, Drug Mixture, classified under FDA regulation 862.3200 as a Class II medical product. It serves as a reference standard for calibrating clinical toxicology assays, ensuring accurate measurement and analysis of therapeutic drug concentrations in biological samples.
The Therapeutic Drug Standard is supplied as a pre-determined mixture of drugs for use in laboratory settings, specifically in clinical toxicology. It is intended for single-use calibration of analytical instruments and is not sterile or reusable. The device is authorized under FDA 510(k) clearance (K880705) and adheres to regulatory standards for drug calibrators, with no specified MRI safety considerations. Storage and handling follow standard laboratory protocols for chemical reference materials.
Frequently asked questions
What is the primary purpose of the Therapeutic Drug Standard from Verichem Laboratories, Inc.?
The Therapeutic Drug Standard is designed as a pre-determined drug mixture calibrator for clinical toxicology assays. Its main purpose is to serve as a reference standard to calibrate analytical instruments, ensuring accurate measurement and analysis of therapeutic drug concentrations in biological samples. This helps laboratories maintain precision in drug testing and monitoring.
Is the Therapeutic Drug Standard intended for single-use or repeated use in a laboratory?
This device is explicitly single-use only and not intended for reuse. It is formulated as a calibrator for one-time use in laboratory settings to standardize toxicology assays, avoiding contamination or degradation risks associated with repeated use.
How should the Therapeutic Drug Standard be stored and handled according to manufacturer guidelines?
Storage and handling follow standard laboratory protocols for chemical reference materials, as specified by the manufacturer. Since it is not sterile, it should be kept in a controlled environment to prevent degradation or contamination, adhering to typical chemical storage practices for calibrators in toxicology labs.
What regulatory pathway was followed for FDA clearance of this device, and what is its classification?
The Therapeutic Drug Standard received FDA 510(k) clearance (K880705) under the traditional review pathway, classified as a Class II medical device under regulation 862.3200. It is categorized as a *Calibrator, Drug Mixture* and falls under the *Clinical Toxicology* specialty, ensuring compliance with FDA standards for drug calibrators.
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: THERAPEUTIC DRUG STANDARD (K880705) — FDA 510(k) | Innolitics, Verichem Laboratories, Inc., VERICHEM LABORATORIES, INC. FDA Filings - FDA.report, Verichem Laboratories, Inc. - FDA, VeriChem - Substance Intelligence
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880705 | Class II | Active |
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Manufacturer
- Manufacturer
- Verichem Laboratories, Inc.
Sources (1)
- FDA 510(k) K880705 24 fields · synced Sep 19, 2026