AST (GOT) Liquid Stable 2 Vial - Dynamic Stabilization Technology (DST)

No FDA recalls on record, checked 22 Oct 2026.

Full name

Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (Dst)

510(k) Number

K980030 ↗

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 Trace America, Inc. →

• What is the AST/GOT Liquid Stable 2 Vial with Dynamic Stabilization Technology used for?

  The AST/GOT Liquid Stable 2 Vial with Dynamic Stabilization Technology (DST) is designed for the quantitative measurement of aspartate aminotransferase (AST) activity in human serum. AST levels are critical for diagnosing and monitoring liver conditions, heart disease, and muscle damage. This reagent reacts with serum samples on automated chemistry analyzers to provide precise AST level quantification, supporting accurate clinical laboratory diagnostics.

• How is the AST/GOT Liquid Stable 2 Vial with DST supplied, and what does this mean for its use?

  The AST/GOT Liquid Stable 2 Vial with DST is supplied as a 2-vial liquid stable reagent. This means it comes in two separate vials, ensuring stability and ease of handling for clinical laboratories. The liquid form allows for straightforward integration into automated chemistry analyzers, while the stability ensures reliable performance without requiring immediate use after opening. Since it is single-use, each vial is intended for one test cycle, reducing the risk of contamination.

• Is the AST/GOT Liquid Stable 2 Vial with DST sterile, and what does this imply for its handling?

  The AST/GOT Liquid Stable 2 Vial with DST is non-sterile. This means it is not intended for direct patient use or procedures requiring sterile conditions. Instead, it is designed for use in controlled laboratory environments where contamination risks are minimized through proper handling protocols. Laboratories must adhere to standard in vitro diagnostic reagent protocols to ensure accuracy and safety when preparing and using the reagent.

• What regulatory clearance does the AST/GOT Liquid Stable 2 Vial with DST hold, and how does this affect its use?

  The AST/GOT Liquid Stable 2 Vial with DST holds FDA 510(k) clearance (K980030), confirming it is substantially equivalent to a legally marketed device under the Traditional 510(k) review pathway. This clearance ensures the reagent meets regulatory standards for safety and effectiveness in measuring AST levels in human serum. Clinicians and laboratories can rely on its compliance with FDA requirements for in vitro diagnostic reagents, though they should always follow manufacturer instructions and local regulatory guidelines for proper use.

• How should the AST/GOT Liquid Stable 2 Vial with DST be stored, and what considerations apply?

  The AST/GOT Liquid Stable 2 Vial with DST follows standard in vitro diagnostic reagent storage protocols, though specific storage conditions are not detailed in the provided data. Generally, such reagents should be stored in a clean, dry environment protected from extreme temperatures, light, and contamination. Laboratories should refer to the manufacturer’s instructions for precise storage guidelines, including temperature ranges and shelf-life information. Proper storage ensures the reagent’s stability and accuracy in AST measurements.