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Quanta Flash Dgp Iga, Quanta Flash Dgp Igg, Quanta Flash Dgp Iga Calibrators, Q…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K113863

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K113863 FDA 510(k)
FDA Product Code
MST FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5750 FDA 510(k)
Regulation Number
866.5750 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The QUANTA FLASH DGP IGA and QUANTA FLASH DGP IGG Calibrators are diagnostic calibrators used in chemiluminescent immunoassays (CIA) to measure IgA and IgG antibodies against deamidated gliadin peptide (DGP). These calibrators establish reference points for quantifying chemiluminescent unit (CU) values in serum samples, enabling accurate detection of anti-DGP antibodies.

These calibrators are supplied for use with the QUANTA FLASH DGP immunoassay system on the BIO-FLASH instrument. They are intended for in vitro diagnostic use and are authorized under FDA 510(k) and IVDD regulations. Each calibrator vial is single-use and requires proper storage to maintain stability, with no specific MRI safety considerations noted. The product codes and registration numbers reflect their classification as Class II devices under medical specialty Immunology.

Frequently asked questions

What clinical purpose do the QUANTA FLASH DGP IGA and IGG Calibrators serve in testing?

These calibrators establish reference points for quantifying chemiluminescent unit (CU) values in serum samples during chemiluminescent immunoassays (CIA). They help ensure accurate detection of IgA and IgG antibodies against deamidated gliadin peptide (DGP), which is useful for diagnosing or monitoring conditions related to gluten sensitivity or celiac disease.

Are the QUANTA FLASH DGP Calibrators single-use or reusable, and how should they be stored?

Each vial of the QUANTA FLASH DGP IGA and IGG Calibrators is designed for single-use only. Proper storage is required to maintain stability, though specific storage conditions (e.g., temperature) are not detailed in the provided data. Always follow manufacturer guidelines to preserve accuracy and reliability.

Which instrument and immunoassay system are these calibrators intended to work with?

The QUANTA FLASH DGP IGA and IGG Calibrators are specifically designed for use with the QUANTA FLASH DGP immunoassay system on the BIO-FLASH instrument. They are not compatible with other systems unless explicitly stated by the manufacturer.

Are there any safety considerations related to MRI when using these calibrators?

The provided data does not mention any MRI safety considerations for the QUANTA FLASH DGP Calibrators. Since they are in vitro diagnostic devices (not implanted or used in MRI environments), they are unlikely to pose MRI-related risks, but always verify compatibility with your facility’s protocols.

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: QUANTA Flash (R) DGP IgA Calibrators | Werfen North America, QUANTA Flash (R) DGP Screen Calibrators - Werfen, Quanta Flash Dgp Iga, Quanta Flash Dgp Igg, Quanta Flash Dgp Iga ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K113863 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026