CK Reagent Cartridge (Product No. 88213)

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

510(k) Number

K861879 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What clinical chemistry analyzers is the CK Reagent Cartridge compatible with, and how is it intended to be used in a lab setting?

  The CK Reagent Cartridge (Product No. 88213) is designed for use in automated clinical chemistry analyzers that perform enzymatic assays. It measures creatine kinase (CK) levels by facilitating reactions that produce NADH, which is then quantified to assess cardiac and muscle tissue health. Since it is a single-use cartridge, it must be inserted into compatible analyzers following the manufacturer’s instructions, ensuring proper handling and compatibility with the analyzer’s reagent system.

• Is the CK Reagent Cartridge sterile, and how should it be stored to maintain its integrity?

  Yes, the CK Reagent Cartridge is supplied sterile and packaged individually to preserve its sterility. Storage should adhere to standard laboratory practices for reagent cartridges, including protection from extreme temperatures, moisture, and direct light. Always follow the manufacturer’s guidelines for optimal shelf life and handling to ensure accurate diagnostic results.

• Can the CK Reagent Cartridge be reused, or is it intended for single-use only?

  The CK Reagent Cartridge is explicitly designed for single-use only. Reusing it could compromise accuracy, introduce contamination, or invalidate test results. Since it is intended for laboratory diagnostics, proper disposal after use is required to maintain regulatory compliance and ensure reliable performance.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?

  The CK Reagent Cartridge received FDA 510(k) clearance (K861879) under the Traditional pathway, classified as a Class II device under regulation 862.1215. This means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, ensuring it meets FDA safety and performance standards. Buyers can rely on this clearance as evidence of regulatory compliance, though they should verify compatibility with their specific analyzer systems.