EMDS Aspartate Aminotransferase (AST) 67657/95

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

Full name

Emds(Tm) Aspartate Aminotransferase (Ast) 67657/95

510(k) Number

K863963 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

  FDA 510(k) K903198 Active Cleared 12 Sep 1990

• Emds Tm Phenobarbital(Phno) Testpack, #67677/95

  Class II

  FDA 510(k) K864926 Active Cleared 7 Jan 1987

• Olympus(Tm) Total Bilirubin

  Class II

  FDA 510(k) K897174 Active Cleared 10 May 1990

• Systamate Aspartate Aminotransferase Test Technico

  Class II

  FDA 510(k) K922857 Active Cleared 9 Sep 1992

• Systemate (Tm) Alanine Transferase (Alt)

  Class II

  FDA 510(k) K863094 Active Cleared 29 Aug 1986

• Systemate Ldh, 67210

  Class II

  FDA 510(k) K843269 Active Cleared 13 Sep 1984

See all devices from Em Diagnostic Systems, Inc. →

• What clinical conditions does the EMDS AST 67657/95 help diagnose?

  This reagent measures aspartate aminotransferase (AST) levels, a key enzyme for assessing liver function and detecting conditions like hepatitis, cirrhosis, or muscle damage. It also supports evaluation of cardiac health, as elevated AST can indicate myocardial injury. The quantitative results aid clinicians in diagnostic decision-making for hepatic and cardiac disorders.

• How is the EMDS AST 67657/95 supplied, and what are its storage requirements?

  The device is supplied as a single-use reagent, ensuring sterility and consistency for each test. It must be stored under controlled conditions to maintain stability and accuracy. Proper storage prevents degradation and ensures reliable performance, as outlined in the manufacturer’s instructions.

• Is the EMDS AST 67657/95 intended for reuse, or is it designed for single-use?

  This reagent is explicitly designed for single-use only. Single-use reagents minimize cross-contamination risk and ensure accurate, reproducible results for each patient sample. Reusing it could compromise sterility and reliability, so adherence to single-use guidelines is critical.

• What regulatory pathway does the EMDS AST 67657/95 follow, and what does that mean for users?

  The device received FDA 510(k) clearance under the Substantially Equivalent determination (K863963), classifying it as a Class II medical device with special controls. This means it meets performance standards for diagnostic reagents, ensuring compliance with Regulation 862.1100. Users can rely on its validated design and manufacturing processes for clinical chemistry applications.

• Are there different models or sizes available for the EMDS AST 67657/95?

  This specific device is identified by the model/reference number 67657/95, indicating a single, standardized formulation for AST measurement. No alternative models or sizes are referenced in the available data, so this reagent is provided uniformly for consistent clinical use.