Creatine Kinase-MB (CK-MB) Reagent Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K935463 FDA 510(k)
- FDA Product Code
- CGS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1215 FDA 510(k)
- Regulation Number
- 862.1215 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Creatine Kinase-MB (CK-MB) Reagent Set is a clinical chemistry reagent set used for the measurement of CK-MB isoenzyme activity in serum or plasma. It is intended for use in diagnostic laboratories to aid in the detection of myocardial infarction.
The reagent set is supplied as a liquid formulation and is designed for use with automated clinical chemistry analyzers. It is provided in a kit configuration with specified volumes of reagents R1 and R2, and is authorized under FDA 510(k) clearance (K935463) for use in the United States.
Frequently asked questions
What is the Creatine Kinase-MB (CK-MB) Reagent Set used for?
The Creatine Kinase-MB (CK-MB) Reagent Set is used to measure CK-MB isoenzyme activity in serum or plasma specimens. This measurement aids in the detection of myocardial infarction by identifying elevated levels of the CK-MB enzyme, which is released when heart muscle is damaged. It is intended for use in diagnostic laboratories performing clinical chemistry testing.
How is the CK-MB Reagent Set supplied and what equipment is it designed for?
The reagent set is supplied as a liquid formulation in a kit configuration containing specified volumes of reagents R1 and R2. It is designed for use with automated clinical chemistry analyzers, which perform the enzymatic assay to quantify CK-MB activity. The liquid format ensures stability and ease of use on compatible instrumentation.
Is the CK-MB Reagent Set sterile or single-use?
The CK-MB Reagent Set is not described as sterile, as it is an in vitro diagnostic reagent intended for use in controlled laboratory environments where sterility is not required. It is supplied in a multi-use kit format with defined reagent volumes, meaning it is not single-use; rather, multiple tests can be performed from the kit until the reagents are exhausted, following the manufacturer’s stability and usage guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CK-MB Reagent Set C7563-30, R1: 1 x 24 mL, R2: 1 x 6 mL (5390012522 ..., Creatine Kinase - MB (CK - MB) Reagent Set - Pointe Scientific, Inc., Pointe Scientific CK (Liquid) Reagents 150 mL | Buy Online | Pointe ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K935463 | Class II | Active |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
- FDA Applicant
- Pointe Scientific, Inc.,
Sources (1)
- FDA 510(k) K935463 24 fields · synced Sep 25, 2026