ACE Amylase Reagent

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

510(k) Number

K951548 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K973582 Active Cleared 12 Nov 1997

• Triglycerides Reagent

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• Ace Hdl-C Reagent

  Class I

  FDA 510(k) K971526 Active Cleared 21 May 1997

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  FDA 510(k) K941489 Active Cleared 18 Jul 1994

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  FDA 510(k) K944911 Active Cleared 10 Feb 1995

• Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C Controls

  Class I

  FDA 510(k) K991733 Active Cleared 13 Jul 1999

See all devices from Schiapparelli Biosystems, Inc. →

• What is the ACE Amylase Reagent used for?

  The ACE Amylase Reagent is a chemistry reagent designed for catalytic methods to measure amylase levels in clinical chemistry applications. It is specifically engineered for use with Ace/Next systems.

• How is the ACE Amylase Reagent supplied?

  The ACE Amylase Reagent is supplied as a single-use reagent in a 7mL size. Each unit is designed for one-time use to ensure accurate test results and maintain sterility.

• What is the regulatory classification of the ACE Amylase Reagent?

  The ACE Amylase Reagent is a Class II medical device cleared by the FDA as substantially equivalent under product code JFJ. It is regulated under 862.1070 for clinical chemistry applications.

• Can the ACE Amylase Reagent be reused?

  No, the ACE Amylase Reagent is supplied as a single-use reagent and should not be reused. This design ensures test integrity and prevents potential contamination between samples.