← Back to catalogue

Envoy 500 CK Reagent Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141265

by Elitechgroup

Identifiers

510(k) Number
K141265 FDA 510(k)
FDA Product Code
JHW 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 Envoy 500 CK Reagent Kit is a reagent kit classified as a U.V. Method, Cpk Isoenzymes device under the Clinical Chemistry nomenclature. It is designed for the quantitative in vitro measurement of creatine kinase (CK) in human serum and plasma, utilizing ultraviolet (UV) detection methods. The kit is intended for use exclusively with the Envoy 500 Chemistry System, a benchtop analyzer, and is not suitable for point-of-care testing. Its primary function is to facilitate biochemical analysis in clinical laboratory settings for diagnostic purposes.

This reagent kit is supplied as a single-use consumable for the Envoy 500 Chemistry System, a benchtop analyzer used in clinical chemistry laboratories. It is intended for use in regulated laboratory environments and requires adherence to standard operating procedures for in vitro diagnostics. The device has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (regulation number 862.1215). Storage and handling must comply with manufacturer guidelines to ensure reagent stability and accuracy of test results.

Frequently asked questions

What clinical chemistry tests does this reagent kit perform, and how is it used in a lab setting?

The Envoy 500 CK Reagent Kit is specifically designed for the quantitative measurement of creatine kinase (CK) in human serum and plasma using ultraviolet (UV) detection. It is intended exclusively for use with the Envoy 500 Chemistry System, a benchtop analyzer in clinical laboratories. This kit is not suitable for point-of-care testing and is used to aid in biochemical analysis for diagnostic purposes, such as assessing cardiac events or muscle disorders.

Is this reagent kit single-use, and if so, how does that impact its use in a laboratory?

Yes, the Envoy 500 CK Reagent Kit is supplied as a single-use consumable for the Envoy 500 Chemistry System. This design ensures consistency and accuracy in test results, as each kit is intended for one use only. Laboratories must adhere to standard operating procedures to maintain reagent stability and avoid cross-contamination, which is critical for reliable diagnostic outcomes.

What regulatory pathway was followed for FDA clearance of this reagent kit, and what classification does it hold?

The Envoy 500 CK Reagent Kit received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device (regulation number 862.1215). This classification indicates that it is subject to stricter controls due to its role in measuring critical biochemical markers like creatine kinase, ensuring its safety and performance in clinical settings.

How should this reagent kit be stored, and what precautions should laboratories take to maintain its integrity?

While specific storage instructions are not detailed in the provided data, the manufacturer’s guidelines must be followed to ensure reagent stability and accuracy. Laboratories should store the kit in a controlled environment, protected from extreme temperatures, light, and contamination. Adherence to these guidelines is essential to preserve the kit’s performance for its intended single-use application on the Envoy 500 Chemistry System.

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: ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT by ELITECHGROUP | FDA ..., ENVOY 500+ - ELITechGroup Clinical Chemistry US, FDA Browser - Cleared 510 (K) - ELITECH CLINICAL SYSTEMS ENVOY 500 CK ..., Elitechgroup Reagents and Controls for Envoy 500 Analyze 55225 - 8.0 Each

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Elitechgroup

Sources (1)

  • FDA 510(k) K141265 24 fields · synced Sep 20, 2026