QuickRead System: CRP Kit Model 06085; QuickRead 101 Instrument Model 06088; CRP Control Set

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Quickread System: Quickread Crp Kit, Model 06085; Quickread 101 Instrument, Model 06088; Quickread Crp Control Set, Mode

510(k) Number

K042442 ↗

FDA Product Code

DCK

Models / Variants

Quickread System: Quickread Crp Kit, Model 06085

Quickread 101 Instrument, Model 06088

Quickread Crp Control Set, Mode

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Pyloriset

  Class I

  FDA 510(k) K904655 Active Cleared 21 Oct 1991

• Rubella Virus Antigens & Controls

  Class II

  FDA 510(k) K802937 Active Cleared 31 Dec 1980

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  Class II

  FDA 510(k) K884074 Active Cleared 27 Oct 1988

• Herpes Simplex Type I

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  FDA 510(k) K802939 Active Cleared 31 Dec 1980

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  FDA 510(k) K821659 Active Cleared 5 Aug 1982

• Immunochemical Determination of Immunoglobulin M

  Class II

  FDA 510(k) K884147 Active Cleared 27 Oct 1988

See all devices from Orion Diagnostica, Inc. →

• What clinical conditions can the QuickRead CRP Kit help evaluate using C-reactive protein levels as a biomarker?

  The QuickRead System measures C-reactive protein (CRP) in whole blood or plasma to assess inflammatory responses. CRP is used as a biomarker to evaluate both infectious and non-infectious inflammatory conditions, such as infections, autoimmune diseases, or other systemic inflammatory processes. It aids clinicians in monitoring disease activity or response to treatment in conditions where inflammation plays a key role.

• Is the QuickRead CRP Kit designed for single-use or repeated use in a clinical setting?

  The QuickRead CRP Kit (Model 06085) is explicitly intended for single-use in clinical laboratory settings. This design ensures patient safety and consistency in test results, as reuse could compromise sterility or accuracy. The accompanying QuickRead 101 Instrument (Model 06088) is also intended for use with single-use kits.

• How is the QuickRead System supplied, and what components are included in the full kit?

  The QuickRead System consists of three main components: the QuickRead CRP Kit (Model 06085), the QuickRead 101 Instrument (Model 06088), and the QuickRead CRP Control Set. These components work together to perform quantitative CRP measurements in whole blood or plasma. The kit is designed for use in clinical laboratories, where the instrument reads results from the single-use CRP test strips included in the kit.

• What regulatory pathway was followed for FDA clearance of the QuickRead System, and what category does it fall under?

  The QuickRead System received FDA 510(k) clearance under Special Review (SESE) in the Immunology category. This classification aligns with its use for measuring CRP, a key biomarker in inflammatory and immune-related evaluations. The device is classified as Class II and regulated under 21 CFR 866.5270, reflecting its role in diagnostic testing for clinical decision-making.