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Titan Gel Iso Dot Cpk Procedure

FDA 510(k)

Class II (US FDA 510(k))

510(k) K842755

by Helena Laboratories

Identifiers

510(k) Number
K842755 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 Titan Gel Iso-Dot CPK Procedure is a diagnostic test used for the qualitative detection of creatine phosphokinase (CPK) isoenzymes and NAD reduction/NADH oxidation activity. It falls under the category of Nad Reduction/NADH Oxidation and CPK or Isoenzymes, designed for clinical chemistry applications. This procedure aids in identifying specific isoenzyme patterns, which can assist in diagnosing conditions such as myocardial infarction or other muscle disorders.

This procedure is supplied as a kit for in vitro diagnostic use in clinical laboratories. It is intended for single-use and requires no special storage conditions beyond those specified in the accompanying instructions. The device is regulated under FDA 510(k) clearance (K842755) and falls under Class II with Special Controls. The procedure is not MRI-compatible, and no specific sterility claims are noted beyond standard laboratory practices for diagnostic reagents.

Frequently asked questions

What clinical conditions can this diagnostic test help identify based on its intended use?

The Titan Gel Iso-Dot CPK Procedure is designed to detect creatine phosphokinase (CPK) isoenzymes and measure NAD reduction/NADH oxidation activity. This helps identify specific isoenzyme patterns, which can assist in diagnosing conditions like myocardial infarction (heart attack) or other muscle disorders by providing insights into tissue-specific enzyme activity.

Is this procedure suitable for reuse, or is it intended for single-use only?

The Titan Gel Iso-Dot CPK Procedure is explicitly intended for single-use only, as stated in the manufacturer’s instructions. This aligns with standard laboratory practices for diagnostic reagents to ensure accuracy and prevent cross-contamination.

What type of storage requirements does this kit have beyond standard laboratory conditions?

The kit does not require any special storage conditions beyond those outlined in the accompanying instructions. This means it can be stored under typical laboratory environmental controls (e.g., temperature, humidity) without additional precautions.

How is this device regulated, and what does its FDA clearance status indicate?

The Titan Gel Iso-Dot CPK Procedure is regulated under the FDA 510(k) clearance process (with clearance number K842755) and falls under Class II with Special Controls. This indicates that it has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in clinical chemistry applications.

Can this procedure be used in conjunction with MRI equipment, or is it MRI-compatible?

The Titan Gel Iso-Dot CPK Procedure is not MRI-compatible. This means it should not be used in or near MRI environments, as the diagnostic reagents may not be safe or effective in such settings.

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: K842755 FDA 510(k) - TITAN GEL ISO DOT CPK PROCEDURE, TITAN GEL ISO DOT CPK PROCEDURE (K842755) - Innolitics, K842755 FDA 510(k) - TITAN GEL ISO DOT CPK PROCEDURE, TITAN Gel Proteins | Helena Laboratories - Innovations for Science ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K842755 24 fields · synced Sep 19, 2026