Acetaminophen (Enzymatic Rate), Number 502-13

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K885097 ↗

FDA Product Code

LDP

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Chemicals, Ltd. (Usa) →

• What is the Acetaminophen (Enzymatic Rate), Number 502-13 used for?

  This device is designed for in vitro diagnostic use in clinical toxicology laboratories to measure acetaminophen levels in biological samples. It employs enzymatic and colorimetric methods to quantify acetaminophen concentrations, helping clinicians assess overdose risks or monitor therapeutic drug levels in emergency or clinical settings.

• How is the Acetaminophen (Enzymatic Rate), Number 502-13 supplied, and is it single-use?

  The assay is supplied as a single-use reagent system, meaning each kit is intended for one-time use only. This ensures consistency and reliability in test results, as reuse could compromise sterility and accuracy. It requires compatibility with standard laboratory equipment and procedures.

• What regulatory pathway and classification does this device follow?

  The Acetaminophen (Enzymatic Rate), Number 502-13 is classified as a Class II medical device under FDA regulation 862.3030. It holds a 510(k) clearance (K885097) through the Traditional pathway, demonstrating substantial equivalence to a predicate device. This classification reflects its role in clinical toxicology assessments.

• Are there specific storage or handling requirements for this assay?

  Storage and handling must strictly follow the manufacturer’s guidelines to maintain the accuracy and reliability of test results. While the exact conditions are not detailed here, typical enzymatic assays require protection from light, moisture, and extreme temperatures. Adherence to these instructions ensures optimal performance and valid diagnostic outcomes.

• What distinguishes this assay from other acetaminophen testing methods?

  This assay uses enzymatic rate methods combined with colorimetric detection, providing a precise and rapid means of quantifying acetaminophen levels. Unlike other methods, this approach leverages enzymatic reactions to generate measurable color changes, enabling clinicians to obtain reliable results in clinical toxicology evaluations with greater specificity.