Whole PTH (1-84) Specific Immunochemiluminometric Assay (ICMA), Model 3KG002

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

510(k) Number

K051141 ↗

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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See all devices from Scantibodies Laboratory Inc. →

• What is the Whole PTH (1-84) Specific Immunoassay, Model 3KG002 used for?

  This device is an in vitro diagnostic reagent kit designed to quantitatively measure whole parathyroid hormone (PTH) levels in human plasma samples. PTH is critical for regulating calcium metabolism, so this assay helps evaluate and diagnose conditions such as hypercalcemia (high calcium) or hypocalcemia (low calcium). By detecting PTH (1-84), clinicians can better assess calcium-related disorders.

• How is the Whole PTH (1-84) ICMA Assay, Model 3KG002 supplied, and is it single-use?

  The assay is supplied as a reagent kit intended exclusively for laboratory use. According to the specifications, it is designed for single-use only, meaning each kit should not be reused after opening or use. This ensures accuracy and sterility for subsequent tests.

• Is the Whole PTH (1-84) ICMA Assay sterile, and can it be reprocessed?

  The provided specifications do not explicitly state whether the kit is sterile or include instructions for reprocessing. As a single-use device, it is generally recommended to follow manufacturer guidelines for storage and handling to maintain integrity. If sterility is required, the accompanying instructions should be consulted for proper use.

• What regulatory approval does the Whole PTH (1-84) ICMA Assay, Model 3KG002 hold?

  The assay has received FDA 510(k) clearance under the Clinical Chemistry advisory committee. It is classified as a Class II medical device under 21 CFR 862.1545, indicating it has been deemed substantially equivalent to a predicate device through the traditional 510(k) review process.

• Does the Whole PTH (1-84) ICMA Assay require special storage conditions?

  The specifications mention that the device requires proper storage as outlined in the accompanying instructions. While specific storage conditions (e.g., temperature, humidity) are not detailed here, adhering to the manufacturer’s guidelines ensures the assay’s performance and stability. Always refer to the included instructions for precise storage recommendations.