ACE Theophylline Reagent, Theo Calibrators

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K973583 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Ace Primidone Reagent, Aed Calibrators

  Class II

  FDA 510(k) K973582 Active Cleared 12 Nov 1997

• Triglycerides Reagent

  Class I

  FDA 510(k) K954187 Active Cleared 23 Oct 1995

• Ace Hdl-C Reagent

  Class I

  FDA 510(k) K971526 Active Cleared 21 May 1997

• Ace Clinical Chemistry System

  Class II

  FDA 510(k) K941489 Active Cleared 18 Jul 1994

• Ace Iron Reagent

  Class I

  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 Theophylline Reagent used for?

  The ACE Theophylline Reagent is an enzyme immunoassay test system used for the quantitative determination of theophylline in human serum or plasma. It operates on a competitive binding principle between an enzyme-labeled drug and free drug from the sample for antibody binding sites.

• How is the ACE Theophylline Reagent supplied?

  The device consists of two reagents: Antibody/Substrate and Enzyme Conjugate. It is supplied as a single-use system and is intended for in vitro diagnostic use only.

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

  The device is classified under Clinical Toxicology test systems and is regulated under 21 CFR 862.3880 with FDA 510(k) clearance (K973583). It has been determined to be substantially equivalent to predicate devices.

• Is the ACE Theophylline Resterile?

  The device information does not specify sterility status. As a single-use system, it is designed for one-time use only and should be handled according to standard laboratory protocols for in vitro diagnostic reagents.