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

K042442 · Orion Diagnostica, OY · DCK · Sep 24, 2004 · Immunology

Device Facts

• Record ID: K042442
• Device Name: QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
• Applicant: Orion Diagnostica, OY
• Product Code: DCK · Immunology
• Decision Date: Sep 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for 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 Story

QuikRead CRP is a quantitative in vitro diagnostic assay for C-reactive protein (CRP) levels in whole blood or plasma. The system utilizes the QuikRead 101 Instrument to process samples. The device measures CRP to assist clinicians in evaluating acute inflammatory processes, whether induced by infectious microbial agents or non-infectious inflammatory stimuli. The QuikRead CRP Control Set is used for quality control of the assay. The system is intended for professional use in clinical settings to aid in clinical decision-making regarding inflammatory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro diagnostic system for CRP quantification. Includes instrument (QuickRead 101) and reagent kit. Modification involves buffer production process for room temperature stability. System utilizes established CRP detection technology. No changes to fundamental scientific technology.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in human whole blood or plasma samples.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K042442

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET,:

1. The name and 510(k) number of ORION DIAGNOSTICA OY's previously cleared device, ORION DIAGNOSTICA QUIKREAD CRP KIT and ORION DIAGNOSTICA QUIKREAD CRP CONTROL, cleared under K031607. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the indicated detection limit to <4.9 connected to a change in the buffer production process to improve buffer stability at room temp (does not report out less than 5mg/L) and the addition of a second CRP-level control ≈ 120 mg/L to meet CLIA requirement.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98