IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)

K071017 · Siemens Medical Solutions Diagnostics · NQD · May 2, 2007 · Immunology

Device Facts

• Record ID: K071017
• Device Name: IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
• Applicant: Siemens Medical Solutions Diagnostics
• Product Code: NQD · Immunology
• Decision Date: May 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for in vitro diagnostic use with the IMMULITE 2500 analyzer for the quantitative measurement of C-reactive protein (CRP) in human serum or plasma, as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Device Story

Solid-phase, two-site, chemiluminescent immunometric assay; used with IMMULITE 2500 Automated Analyzer. Input: human serum or plasma samples. Operation: automated analyzer performs immunochemical measurement of CRP levels. Output: quantitative CRP concentration. Used in clinical laboratory settings by trained laboratory personnel. Results provided to physicians to assist in evaluating inflammatory states, tissue injury, and cardiovascular risk assessment. Enables clinical decision-making regarding patient management for coronary disease and inflammatory conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance and technological similarity to the predicate device.

Technological Characteristics

Solid-phase, two-site, chemiluminescent immunometric assay. Designed for use on the IMMULITE 2500 Automated Analyzer. Quantitative measurement of CRP in serum/plasma. In vitro diagnostic reagent system.

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in serum or 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

• IMMULITE 2000 High Sensitivity CRP assay (K063057)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K071017

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I 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. (For a preamendments device, a statement to this effect has been provided.) k063057
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).
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 introduction of the IMMULITE 2000 High Sensitivity CRP assay onto the IMMULITE 2500 Analyzer. The assays are equivalent in all aspects except incubation time, which is shortened from 1 cycle of 30 minutes on the IMMULITE 2000 to 1 cycle of 10 minutes on the IMMULITE 2500.

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