Acetaminophen Assay (ACE), Catalogue Number 503-10

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K980031 ↗

FDA Product Code

LDP

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the Acetaminophen Assay (ACE) 503-10 kit used for?

  The Acetaminophen Assay (ACE) 503-10 is an in vitro diagnostic reagent kit designed for quantitative measurement of acetaminophen concentrations in human serum. It aids clinicians in assessing acetaminophen toxicity, which is critical for diagnosing and managing overdoses or excessive exposure in patients. The colorimetric method provides reliable results for clinical toxicology evaluations in laboratory settings.

• How is the Acetaminophen Assay (ACE) 503-10 kit supplied?

  The kit is supplied as a reagent kit, containing all necessary components for performing the colorimetric assay. It is intended for use exclusively in clinical laboratory environments, where trained personnel can conduct the test following the manufacturer’s instructions. The kit is not intended for point-of-care or home use.

• Is the Acetaminophen Assay (ACE) 503-10 kit sterile?

  The provided device data does not specify sterility status explicitly. However, as an in vitro diagnostic reagent kit for laboratory use, it is typically designed to prevent contamination during handling and testing. For precise sterility information, refer to the manufacturer’s instructions or safety data sheet accompanying the kit.

• Is the Acetaminophen Assay (ACE) 503-10 kit single-use or reusable?

  The kit is intended for single-use per the manufacturer’s design and regulatory classification as an in vitro diagnostic reagent. Reusing components could compromise accuracy, reliability, or sterility, potentially leading to incorrect test results or safety risks. Always follow the manufacturer’s guidelines for proper disposal after use.

• What regulatory pathway was followed for FDA clearance of the Acetaminophen Assay (ACE) 503-10?

  The Acetaminophen Assay (ACE) 503-10 received FDA clearance under the Traditional 510(k) pathway, classified as Substantially Equivalent (SESE) to a predicate device. This pathway demonstrates that the device is as safe and effective as a legally marketed alternative. The clearance was granted on March 3, 1998, and the device falls under FDA regulation number 862.3030, categorized as Device Class 2.