Creatine Kinase for Manual/Automated Applications

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894715 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase (Alt)/(Gpt)

  Class I

  FDA 510(k) K870086 Active Cleared 6 Mar 1987

• Aspartate Aminotransferase (Ast)/(Got)

  Class II

  FDA 510(k) K870077 Active Cleared 6 Mar 1987

• Uibc for Discreet Random Access Analyzer

  Class I

  FDA 510(k) K932871 Active Cleared 8 Sep 1993

• Direct Bilirubin for Manual or Automated Appli.

  Class II

  FDA 510(k) K892905 Active Cleared 19 Jun 1989

• Magnesium

  Class I

  FDA 510(k) K903341 Active Cleared 22 Aug 1990

• Uric Acid for Manual/Automated Applications

  Class I

  FDA 510(k) K895821 Active Cleared 5 Dec 1989

See all devices from Catachem, Inc. →

• What clinical conditions is this Creatine Kinase assay primarily used to diagnose or monitor, and how does it help in those cases?

  This Creatine Kinase (CK) Assay Reagent is designed to measure CK enzyme activity in blood or serum, which is critical for diagnosing and monitoring conditions like myocardial infarction (heart attack), muscle disorders, and metabolic or muscular pathologies. Elevated CK levels can indicate muscle damage, helping clinicians identify acute cardiac events or muscular diseases early, thereby guiding timely treatment decisions.

• Is this reagent compatible with both manual and automated laboratory testing systems, and what does that mean for workflow flexibility?

  Yes, this CK Assay Reagent is explicitly formulated for use in *both* manual and automated laboratory workflows. This dual-compatibility allows laboratories to integrate the test into their preferred testing environment—whether they rely on traditional manual methods or streamlined automated systems—without needing separate reagents, which enhances flexibility and efficiency in clinical chemistry labs.

• How should the reagent be stored, and what are the implications of proper storage on its performance?

  The reagent requires standard refrigeration between 2–8°C with no additional storage requirements. Proper refrigeration ensures stability and maintains the reagent’s accuracy and reliability for measuring CK activity, preventing degradation that could lead to inaccurate test results or compromised diagnostic confidence.

• Is this a single-use product, and if so, how does that impact inventory management and cost efficiency for laboratories?

  Yes, this CK Assay Reagent is supplied as a single-use diagnostic kit, designed for one-time use per test. This approach minimizes contamination risk and ensures consistent, reproducible results per batch. For laboratories, this means managing inventory carefully to avoid waste while maintaining compliance with single-use protocols, though it may require more frequent restocking compared to reusable alternatives.

• What regulatory pathway was followed for FDA clearance, and how does that classification (Class II) affect its use in clinical settings?

  The reagent received FDA 510(k) clearance (K894715) under the Clinical Chemistry advisory committee, classified as substantially equivalent (SESE) and falling under 21 CFR 862.1215. As a Class II device, it undergoes rigorous premarket review to ensure safety and effectiveness, which reassures clinicians of its reliability for diagnosing conditions like myocardial infarction or muscle disorders. The clearance also implies adherence to quality standards for clinical chemistry assays.