Modification to Whole PTH (1-84) Specific Immunochemilluminometric (ICMA) Assay Kit, Model 3KG002

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K060420 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Total Intact Pth Immunoradiometric Assay (Coated Tube Version), Model 3KG013

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• Scantibodies Laboratory Tsh Immunoradiometric Assay (Irma)(Coated Tube Technology)

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See all devices from Scantibodies Laboratory Inc. →

• What is the purpose of the Whole PTH (1-84) ICMA assay kit?

  The Whole PTH (1-84) ICMA assay kit is an in vitro diagnostic test used to quantify parathyroid hormone levels in human plasma samples. It utilizes an immuno-chemiluminometric assay principle to detect the hormone for laboratory use.

• How is the Whole PTH (1-84) ICMA assay kit supplied?

  The assay kit is supplied as a modification to an existing device. It is intended for laboratory use and is not specified as single-use or reusable. The device is supplied with all necessary components for performing the immuno-chemiluminometric assay.

• What is the regulatory status of the Whole PTH (1-84) ICMA assay kit?

  The device is a Class II device with FDA 510(k) clearance K060420, granted on March 1, 2006, with a decision of Substantially Equivalent. It is regulated under product code CEW and is not specified as single-use or reusable.

• What are the specifications of the Whole PTH (1-84) ICMA assay kit?

  The assay kit is designed for laboratory use and utilizes an immuno-chemiluminometric assay principle to detect parathyroid hormone levels in human plasma samples. The device is a modification to an existing device and is not specified as single-use or reusable.