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510(k) Data Aggregation

K Number

Device Name

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

Manufacturer

ORION DIAGNOSTICA OY

Date Cleared

2004-09-24

(15 days)

Product Code

DCK,JJX

Regulation Number

866.5270

Type

Special

Panel

Clinical Chemistry (CH)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli.

QuikRead CRP Control Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument.

For in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

This letter is a 510(k) clearance letter from the FDA. It does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies. The letter primarily states that the device, Orion Diagnostica QuikRead® CRP kit and its control set, is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate performance study report.

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