Aspartate Aminotransferase (AST) Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935181 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Em Diagnostic Systems, Inc. →

• What clinical applications is the Aspartate Aminotransferase (AST) Test primarily used for in a laboratory setting?

  The AST Test is designed for clinical chemistry applications to help assess liver function and detect potential liver or heart damage. Elevated AST levels can indicate tissue injury, so this test aids in diagnosing conditions like hepatitis, cirrhosis, or myocardial infarction by measuring serum aspartate aminotransferase enzyme levels.

• How is the Aspartate Aminotransferase (AST) Test supplied, and is it intended for single-use?

  The AST Test is supplied as a reagent kit for use in clinical laboratories. According to the manufacturer’s specifications, it is intended for single-use only, ensuring accuracy and reliability in diagnostic results without risk of cross-contamination.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The AST Test received FDA clearance through a 510(k) submission (K935181) under the Traditional clearance type, determined to be Substantially Equivalent to a predicate device. It is classified as a Class II medical device under product code CIT, subject to special controls for clinical chemistry applications.

• Does the manufacturer provide specific storage instructions to maintain the test’s accuracy?

  While the exact storage instructions are not detailed in the provided data, the manufacturer emphasizes that proper storage and handling are required to maintain the accuracy and reliability of the AST Test results. Laboratories should follow the manufacturer’s guidelines (Em Diagnostic Systems, Inc.) to preserve reagent integrity.