Acro Biotech LLC Rapid Amphetamine Urine Test Catalog# AMP001000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053032 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
- Models / Variants
- Catalog# Amp001000 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and in monitoring levels of amphetamine to ensure appropriate therapy.
The device is supplied as a rapid test system and is authorized under FDA 510(k) clearance K053032. It is classified as a Class II device under regulation number 862.3100 with product code DKZ and is intended for use in clinical toxicology settings.
Frequently asked questions
What is the ACRO BIOTECH RAPID AMPHETAMINE URINE TEST used for?
This test system is designed to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. The measurements are used in the diagnosis and monitoring of amphetamine levels to ensure appropriate therapy for patients.
How is the ACRO BIOTECH RAPID AMPHETAMINE URINE TEST supplied?
The device is supplied as a rapid test system, providing quick results for clinical toxicology settings. It comes with catalog number AMP001000 and is manufactured by Acro Biotech, LLC.
What is the regulatory status of the ACRO BIOTECH RAPID AMPHETAMINE URINE TEST?
This test is authorized under FDA 510(k) clearance K053032 and is classified as a Class II device under regulation number 862.3100 with product code DKZ. It is intended for use in clinical toxicology settings.
Is the ACRO BIOTECH RAPID AMPHETAMINE URINE TEST reusable or single-use?
The device is supplied as a rapid test system, which typically indicates it is designed for single-use to ensure accurate results and prevent cross-contamination between samples.
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: Acro Biotech Llc Rapid Amphetamine Urine Test; Catalog# Amp001000, Acro Biotech Rapid Test Catalogue | PDF - Scribd, PRODUCTS | Acro Biotech, Inc., Rapid Tests | Acro Biotech, Inc. | United States
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053032 | Class II | Active |
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Manufacturer
- Manufacturer
- Acro Biotech, LLC
Sources (1)
- FDA 510(k) K053032 24 fields · synced Sep 26, 2026