VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

K152433 · Ortho Clinical Diagnostics · DCK · Sep 24, 2015 · Immunology

Device Facts

• Record ID: K152433
• Device Name: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
• Applicant: Ortho Clinical Diagnostics
• Product Code: DCK · Immunology
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

VITROS Chemistry Products CRP Slides: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections. VITROS Chemistry Products Calibrator Kit 7: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.

Device Story

VITROS Chemistry Products CRP Slides; in vitro diagnostic assay for quantitative CRP measurement in human serum/plasma; utilizes thin-film multilayer slide technology; operated by laboratory personnel in clinical settings; modification involves updating calibrator reference standard from ERM-DA472 to ERM-DA474; output provides CRP concentration values to aid clinical inflammation assessment.

Clinical Evidence

Bench testing only. Performance studies conducted to verify the impact of the calibrator reference standard change (ERM-DA472 to ERM-DA474) on assay performance. No clinical data provided.

Technological Characteristics

Thin-film multilayer slide technology for quantitative chemistry analysis. Modification: update of calibrator reference standard to ERM-DA474. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma to aid in the evaluation of inflammation.

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.

Predicate Devices

• VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7 (K030626)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K152433

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7(K030626).

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 (labeling changes are permitted as long as they do not affect the intended use). The labeling was updated with the current performance values obtained from the testing of the calibrator reference standard ERM-DA474. The changes do not affect the intended use.

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:
a. Modification from calibrator reference standard from ERM-DA472 to ERM-DA474.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance studies of the VITROS Chemistry Products CRP Slides assay and Calibrator Kit 7.

5. 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

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.