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CHROM Z-Protein C, Cat. No. 5243

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952666

by Helena Laboratories

Identifiers

510(k) Number
K952666 FDA 510(k)
FDA Product Code
GGP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7290 FDA 510(k)
Regulation Number
864.7290 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CHROM Z-Protein C, Cat. No. 5243 is a qualitative and quantitative test for detecting Protein C deficiency, a condition associated with hematological disorders. As classified under product code GGP, this device measures Protein C levels in plasma, aiding in the diagnosis of coagulation factor deficiencies and related thrombotic risks. It operates as an in vitro diagnostic tool, providing results to support clinical assessments in hematology.

This device is supplied as a single-use diagnostic reagent intended for use in clinical laboratories. It requires standard laboratory equipment, including a spectrophotometer, and is designed for qualitative and quantitative analysis of Protein C levels in human plasma samples. The device is regulated under FDA 510(k) clearance (K952666) and falls under Class II, adhering to special controls for in vitro diagnostics. Storage and handling follow standard laboratory protocols for diagnostic reagents, ensuring accuracy and reliability of test results.

Frequently asked questions

What is the CHROM Z-Protein C, Cat. No. 5243 used for?

The CHROM Z-Protein C, Cat. No. 5243 is an in vitro diagnostic reagent designed to detect and measure Protein C levels in human plasma. Protein C deficiency is linked to hematological disorders and increased thrombotic risk, so this test supports clinical assessments in hematology by providing qualitative and quantitative results to aid in diagnosing coagulation factor deficiencies.

How is the CHROM Z-Protein C, Cat. No. 5243 supplied and intended for use?

This device is supplied as a single-use diagnostic reagent kit. It is intended exclusively for use in clinical laboratories equipped with standard laboratory equipment, including a spectrophotometer. The test requires human plasma samples for qualitative and quantitative analysis of Protein C levels, ensuring accurate clinical decision-making.

Is the CHROM Z-Protein C, Cat. No. 5243 sterile and single-use?

Yes, the CHROM Z-Protein C, Cat. No. 5243 is designed as a single-use diagnostic reagent. While the provided data does not explicitly state sterility, it aligns with standard laboratory protocols for diagnostic reagents, which typically require sterility to prevent contamination and ensure reliable test results. Always follow manufacturer guidelines for handling and storage.

What regulatory clearance does the CHROM Z-Protein C, Cat. No. 5243 hold?

The CHROM Z-Protein C, Cat. No. 5243 holds FDA 510(k) clearance under the reference number K952666. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and falls under Class II regulatory classification, adhering to special controls for in vitro diagnostics.

How should the CHROM Z-Protein C, Cat. No. 5243 be stored?

Storage and handling of the CHROM Z-Protein C, Cat. No. 5243 follow standard laboratory protocols for diagnostic reagents. While specific storage conditions are not detailed, it is generally recommended to store the reagent in a clean, dry environment, protected from extreme temperatures and light, to maintain its accuracy and reliability. Always refer to the manufacturer’s instructions for precise storage 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: CHROM Z-PROTEIN C, CAT. NO. 5243 by HELENA LABORATORIES | FDA 510 (k ..., CHROM Z-PROTEIN C, CAT. NO. 5243 (K952666) — FDA 510 (k) | Innolitics, K952666 FDA 510(k) - CHROM Z-PROTEIN C | Helena Laboratories

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K952666 24 fields · synced Oct 1, 2026