An Amphetamine Test System is a diagnostic device designed to measure the presence of amphetamines in biological samples such as plasma and urine. This system is primarily used for both qualitative and semiquantitative detection, allowing healthcare providers to identify whether a patient has consumed amphetamines, including common medications like Adderall and Benzedrine, which contain these substances. The testing process typically starts with a qualitative screening, followed by quantitative assays to determine if amphetamine levels exceed recommended thresholds, helping to monitor potential misuse or overdose.

Intended Use of Amphetamine Test System

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 treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Intended Use:

Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine.

Device Description:

Multi-Drug Test Cup are immunochromatographic assay that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. The test device is sealed with sachets of desiccant in an aluminium pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Software, Similarity Score Algorithm, Tissue of Origin for Malignant Tumour Types

Intended Use:

The Cancer Genetics Tissue of Origin Test is an in vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient’s formalin-fixed, paraffin-embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. This test should be evaluated by a qualified physician in the context of the patient’s clinical history and other diagnostic test results.

Device Description:

The kit includes a reagent set and instructions, along with a microchip and software, to compare the RNA expression pattern of a patient’s tumor sample to a database of expression patterns from 15 known tumor types.

Enzyme Immunoassay, Amphetamine

Intended Use:

The assay is a homogeneous enzyme immunoassay used for determining ecstasy drugs in human urine. It provides a simple and rapid analytical screening procedure at a cutoff level of 500 ng/mL. This product is intended for clinical laboratories only and provides only a preliminary analytical test result. A more specific chemical method, such as gas chromatography/mass spectrometry (GC/MS) or liquid chromatography with tandem mass spectrometry (LC-MS/MS), is preferred for confirmation.

Device Description:

The Assay is a homogeneous enzyme immunoassay used to detect ecstasy drugs in human urine. Ecstasy drugs are ring substituted methylenedioxy analogues of amphetamine, including MDMA and MDEA. They are commonly abused for their psychotropic effects and are listed as Schedule I by the U.S. Drug Enforcement Administration. At low doses, they produce euphoria, self-awareness, and trust. At higher doses, they are hallucinogenic. The assay’s detection depends on factors like drug frequency, metabolism, excretion rate, drug half-life, and the user’s age, weight, activity, and diet. It is a first-line device for diagnosing ecstasy abuse.

• Reagent Stability
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical specificity
• Accuracy(recovery)
• Interfering Substances

Clinical Testing:

No Guidance available for 510k submission