Aspartate Aminotransferase Test Item No. 65654

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K884377 ↗

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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• What is the Aspartate Aminotransferase Test used for?

  The Aspartate Aminotransferase Test is a clinical chemistry test used to measure levels of AST in the blood. AST is an enzyme found in the liver, heart, muscles, and other tissues, making this test valuable for assessing liver function and detecting potential liver cell damage.

• How is the Aspartate Aminotransferase Test supplied?

  The test is supplied as a single-use item, designed for one-time use only. It is manufactured by Em Diagnostic Systems, Inc. and intended specifically for use in clinical chemistry laboratories to ensure accurate testing results.

• What is the regulatory status of this test?

  The Aspartate Aminotransferase Test has received FDA 510K clearance with device class 2 status. It is authorized for use in the United States and is subject to regulation 862.1100, ensuring it meets specific safety and effectiveness requirements.

• What tissues does the AST test evaluate?

  The AST test evaluates aspartate aminotransferase levels in the blood, which is an enzyme found in various tissues including the liver, heart, muscles, and other bodily tissues. This makes it useful for detecting damage to these organs, particularly the liver.