TINA-QUANT CRP (LATEX)

K032336 · Roche Diagnostics Corp. · DCN · Aug 5, 2003 · Immunology

Device Facts

• Record ID: K032336
• Device Name: TINA-QUANT CRP (LATEX)
• Applicant: Roche Diagnostics Corp.
• Product Code: DCN · Immunology
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Device Story

Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric assay used on automated clinical chemistry analyzers. Anti-CRP antibodies coupled to latex microparticles react with CRP antigen in human serum or plasma samples to form antigen/antibody complexes. The resulting turbidity is measured by the analyzer; the degree of turbidity is proportional to the CRP concentration in the sample. The device is intended for use by laboratory professionals in clinical settings. Results assist clinicians in evaluating the extent of tissue injury. The assay provides quantitative CRP levels, facilitating clinical decision-making regarding inflammatory or injury-related conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance comparisons between the subject device and the predicate, including measuring range verification and sample type compatibility.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay; utilizes anti-CRP antibodies coupled to latex microparticles. Designed for use on automated clinical chemistry analyzers (e.g., Roche/Hitachi series). Measuring range varies by analyzer (e.g., 1-265 mg/L to 1-560 mg/L with rerun).

Indications for Use

Indicated for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma to aid in the evaluation of tissue injury.

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

• Roche Diagnostics Tina-quant CRP (Latex) HS assay (K003400)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032336

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):

1. The name and 510(k) number of ROCHE DIAGNOSTICS CORP.'s previously cleared device, CRP HS TEST SYSTEM, cleared under K003400. (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 broadening the assay range, increasing buffer conc., deleting citrated and adding K2-EDTA plasma specimen type and name change.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.
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
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)

August 1, 2003 (Date)

revised:3/27/98