Visualine II Amphetamine Assay

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Visualine II (Also Known As Sunline) Amphetamine Assay

510(k) Number

K010177 ↗

FDA Product Code

DKZ

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Visualine II (Also Known As Sunline) Methadone

  Class II

  FDA 510(k) K981314 Active Cleared 4 Sep 1998

• Visualine II (Also Known As Sunline) Phencyclidine

  Unclassified

  FDA 510(k) K983790 Active Cleared 1 Mar 1999

• Visualine Methadone Dipstriptest

  Class II

  FDA 510(k) K023856 Active Cleared 25 Aug 2003

• Visualine Combo V (Cocaine/Thc) Test

  Class II

  FDA 510(k) K963606 Active Cleared 30 Oct 1996

• Visualine D Hcg

  Class II

  FDA 510(k) K963408 Active Cleared 18 Oct 1996

• Visualine II Methamphetimine

  Class II

  FDA 510(k) K972032 Active Cleared 12 Aug 1997

See all devices from Sun Biomedical Laboratories, Inc. →

• What types of biological specimens can the Visualine II Amphetamine Assay detect amphetamine in, and how is it typically used in clinical settings?

  The Visualine II Amphetamine Assay is designed for the qualitative detection of amphetamine in urine and other relevant biological specimens, primarily used in clinical toxicology settings. It helps identify the presence of amphetamine metabolites, aiding in confirming substance exposure or overdose cases. The assay follows standard immunoassay procedures in clinical laboratories and toxicology testing facilities.

• Is the Visualine II Amphetamine Assay intended for single-use or repeated use, and what storage conditions are required?

  The Visualine II Amphetamine Assay is supplied as a single-use diagnostic test kit, meaning each kit is intended for one test only. Storage requirements are straightforward—it should be kept under refrigeration or as directed in the accompanying instructions, with no additional specialized conditions needed.

• How is the regulatory status of this device determined, and what does the FDA clearance indicate about its use?

  The Visualine II Amphetamine Assay holds an FDA 510(k) clearance (K010177), which means it has been deemed substantially equivalent to a legally marketed device already on the market. This clearance confirms it meets FDA standards for enzyme immunoassays for amphetamine detection and is classified as a Class II medical device under regulation 862.3100. It is intended for use in clinical laboratories and toxicology testing, adhering to standard immunoassay protocols.

• Are there different models or sizes available for the Visualine II Amphetamine Assay, or is it provided in a standardized format?

  The provided data does not specify multiple models or sizes for the Visualine II Amphetamine Assay. It is described as a single-use diagnostic test kit, implying a standardized format for qualitative amphetamine detection in biological specimens. If variations exist, they are not detailed in the available information.

• What is the primary purpose of the Visualine II Amphetamine Assay in a clinical toxicology context, and how does it contribute to patient care?

  The primary purpose of the Visualine II Amphetamine Assay is to qualitatively detect amphetamine metabolites in biological specimens, such as urine, to assist in diagnosing amphetamine exposure or overdose. In clinical toxicology, this helps clinicians confirm substance use, guide treatment decisions, and monitor patient safety by providing rapid, evidence-based results.