Cardiozyme Plus CK-Total Item #65046

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811574 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultra Zyme Plus Ck-1 #64978, 65027 & 28

  Class II

  FDA 510(k) K812593 Active Cleared 2 Oct 1981

• Ultrachem Phosphorus, 64973

  Class I

  FDA 510(k) K772156 Active Cleared 6 Dec 1977

• Ultrachem Total Protein, #64974

  Class II

  FDA 510(k) K772155 Active Cleared 6 Dec 1977

• Ultrazyme Plus Alp

  Class II

  FDA 510(k) K770870 Active Cleared 14 Jul 1977

• Ultra Zyme Plus Gpt, #64956, 65035 & 36

  Class I

  FDA 510(k) K812591 Active Cleared 24 Sep 1981

• Ultrazyme Alkaline Phosphatase

  Class II

  FDA 510(k) K760024 Active Cleared 26 Aug 1976

See all devices from Harleco →

• What clinical chemistry tests does the Cardiozyme Plus CK-Total Item #65046 support, and how is it used in a lab setting?

  The Cardiozyme Plus CK-Total Item #65046 is designed for performing NAD Reduction/NADH Oxidation tests, specifically for measuring creatine phosphokinase (CPK) or its isoenzymes. This test system is used in clinical chemistry to help assess cardiac health by measuring enzyme levels, particularly useful in diagnosing myocardial infarction or other cardiac conditions. It operates by quantifying the enzymatic activity involved in energy metabolism within cells.

• Is this device intended for single-use or reusable applications in a clinical setting?

  The Cardiozyme Plus CK-Total Item #65046 is not explicitly described as single-use or reusable in the provided data. However, given its classification as a Nad Reduction/NAdh Oxidation, CPK or Isoenzymes test system and its role in clinical chemistry testing, it is most likely intended for single-use per test kit or reagent vial to ensure accuracy and prevent cross-contamination. Always follow manufacturer guidelines for proper usage and disposal.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in the U.S.?

  The Cardiozyme Plus CK-Total Item #65046 was cleared via the FDA 510(k) pathway under K811574, submitted by Harleco of McHenry, Illinois. This means the device was determined to be substantially equivalent to a legally marketed device already on the market, fulfilling FDA requirements for safety and effectiveness. The clearance was granted on June 25, 1981, under product code CGS and regulation number 862.1215, confirming its compliance for clinical chemistry use in the U.S.

• Are there multiple versions or sizes of this test system, and how should it be stored?

  The provided data does not specify multiple versions or sizes of the Cardiozyme Plus CK-Total Item #65046, but it is associated with multiple FEI numbers and registration numbers, which may indicate variations in packaging or lot-specific identifiers. For storage, while not explicitly detailed, clinical chemistry reagents like this are typically stored according to manufacturer instructions—usually in a cool, dry place, protected from light and extreme temperatures. Always check the packaging or accompanying documentation for precise storage guidelines to maintain reagent integrity.