Skip to content

Prisma-C-Reactive Protein Calibrators

by Syva Co. 510(k)

Active United States

510(k) K823417

Overview

The Prisma C-Reactive Protein Calibrators are in vitro diagnostic controls designed for quantifying C-reactive protein (CRP) levels in serum or plasma. These calibrators provide reference standards to ensure accuracy and precision in immunoassay measurements, supporting clinical assessments of inflammation or infection.

Supplied as liquid controls, these calibrators are intended for single-use in laboratory settings and require no special storage conditions beyond refrigeration. They are classified under FDA product code DCK and were granted 510(k) clearance (K823417) in 1982, adhering to Class II regulatory requirements. No MRI safety or sterility specifications are noted in the regulatory data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823417 Date9 Dec 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Syva Co.

See all devices from Syva Co. →

Questions

  • What is the primary purpose of the Prisma C-Reactive Protein Calibrators in a clinical lab setting?

    The Prisma C-Reactive Protein Calibrators are designed to serve as reference standards for quantifying C-reactive protein (CRP) levels in serum or plasma. They help ensure the accuracy and precision of immunoassay measurements, which are critical for assessing inflammation or infection in patients. By providing calibrated controls, these products support reliable clinical assessments.

  • Are these calibrators intended for single-use or repeated use, and what storage requirements apply?

    The Prisma C-Reactive Protein Calibrators are explicitly labeled for single-use in laboratory settings. They are supplied as liquid controls and do not require special storage conditions beyond standard refrigeration, making them convenient for routine use without additional handling constraints.

  • How were these calibrators classified by the FDA, and what does that mean for their regulatory pathway?

    These calibrators were granted 510(k) clearance (K823417) under the FDA’s Class II regulatory requirements, with a substantially equivalent determination (SESE). This means the device was reviewed by the FDA’s Immunology (IM) advisory committee and deemed comparable to legally marketed predecessors, ensuring compliance with safety and performance standards for in vitro diagnostic controls.

  • What product code and regulatory category does the Prisma C-Reactive Protein Calibrators fall under?

    The calibrators are classified under FDA product code DCK (Diagnostic Controls) and fall within the Immunology medical specialty. This categorization reflects their role as reference standards for immunoassay-based CRP testing, aligning with regulatory frameworks for diagnostic accuracy and precision.