Quantitope 125I AFP Kit and Control Serum

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

PMA Number

P800025 ↗

FDA Product Code

LOK

Device Class

Class III

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S003

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• What is the primary clinical purpose of the Quantitope 125I AFP Kit and Control Serum, and how does it function?

  The Quantitope 125I AFP Kit is designed for **quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma** using radioimmunoassay (RIA) technology. It helps detect elevated AFP levels, which may signal potential neural tube defects or other prenatal abnormalities during pregnancy screening. The kit relies on RIA to bind AFP with labeled antibodies, enabling precise detection of abnormal concentrations.

• Is this kit intended for single-use or repeated use, and what sterilization considerations apply?

  The Quantitope 125I AFP Kit is explicitly labeled as a **single-use diagnostic reagent kit**. No additional sterilization is required beyond the manufacturer’s sealed packaging, as it is intended for one-time use in clinical laboratory settings. Reuse is not supported or recommended.

• How is the kit authorized for use in the U.S., and what regulatory pathway was followed?

  The kit is authorized under **FDA Premarket Approval (PMA)** with PMA number **P800025**, indicating it underwent a rigorous review process to demonstrate safety and effectiveness. This pathway is typically reserved for high-risk medical devices, ensuring compliance with stringent regulatory standards for in vitro diagnostics.

• Does the kit include quality assurance measures, and if so, what form does it take?

  Yes, the Quantitope 125I AFP Kit includes **control serum** as part of its design, which serves as a quality assurance tool. This control helps validate the accuracy and reliability of test results by providing a reference standard for comparison during laboratory use.