An acetaminophen test system measures the amount of acetaminophen in your blood. It’s a blood test that can help diagnose an overdose, assess liver damage, and determine treatment

Intended Use of Acetaminophen Test System

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Intended Use:

It is used for the quantitative determination of acetaminophen in human serum or plasma and used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.

Device Description:

An Acetaminophen Test System is used to measure acetaminophen levels in biological samples (blood, serum, urine, or plasma), especially in cases of overdose. These systems typically consist of a reagent that reacts with acetaminophen, producing a measurable change (like a color shift or fluorescence), and an instrument that quantifies the change. Common devices include colorimetric assays, which require a spectrophotometer or colorimeter to measure absorbance at specific wavelengths, and automated clinical chemistry analyzers  which streamline the testing process. Test strips offer a simpler, point-of-care option, where color changes on the strip indicate acetaminophen levels, and fluorescence-based assays use fluorometers for highly sensitive detection. These devices are crucial in diagnosing and managing acetaminophen overdose, providing rapid and accurate results for timely intervention.

Performance Testing (Analytical) for Acetaminophen Test System

• Precision/Reproducibility
• Linearity/Assay Reportable Range
• Detection Limit
• Analytical Specificity
• Traceability (Controls, Calibrators, Or Method)
• Interference
• Analytical Sensitivity

Clinical Testing

Not Applicable for 510k submission