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

Intended 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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# Section 14 - 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

#### Establishment Name:

Siemens Medical Solutions Diagnostics 5700 West 96th Street Los Angeles, CA 90045-5597

MAY - 2 2007

Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900

Telephone Number: [phone]

Facsimile Number: [phone]

- Deborah L. Morris Contact Person: Director, Clinical Affairs & Regulatory Submissions
Date of Preparation: April 6, 2007

Device Trade Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay

Catalog Number: L5KCRP

21 CFR 862.1377: 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.

| Device Common Name: | Reagent system for the determination of C-reactive protein in plasma or serum. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II device; Product Code: NQD (21 CFR 866.5270) |
| Panel: | Immunology |
| CLIA Complexity<br>Category: | We believe the category to be moderate based on previous<br>classification of analogous tests. |
| Manufacturer: | Siemens Medical Solutions Diagnostics<br>5700 West 96th Street<br>Los Angeles, CA 90045-5597<br><br>Siemens Medical Solutions Diagnostics<br>5210 Pacific Concourse Drive<br>Los Angeles, CA 90045-6900 |

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#### Establishment Registration Number:

Siemens Medical Solutions Diagnostics 5700 West 96th Street Los Angeles, CA 90045-5597 Registration #: 2017183

Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 Registration #: 3005250747

#### Substantially Equivalent Predicate Device:

IMMULITE 2000 High Sensitivity C-Reactive Protein Immunoassay (K063057, K003372)

#### Description of Device:

The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,

#### Intended Use of the Device:

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.

- Conclusion: The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Siemens Medical Solutions Diagnostics substantial equivalence for the IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming a protective shape.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Medical Solutions Diagnostics c/o Ms. Deborah L. Morris. Director of Clinical Affairs & Regulatory Submissions 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900

રિક: k071017

> Trade/Device Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay Regulation Number: 21 CFR§ 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NOD Dated: April 6, 2007 Received: April 10, 2007

MAY - 2 2007

Dear Ms. Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, perroits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 4071017 510(k) Number (if known):

Device Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein

Indications For Use:

The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and 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 (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K07 1017

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