SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT

K070626 · Beckman Coulter, Inc. · NQD · May 4, 2007 · Immunology

Device Facts

• Record ID: K070626
• Device Name: SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: NQD · Immunology
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX 20 PRO System. UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.

Device Story

In vitro diagnostic reagent for quantitative determination of C-Reactive Protein (CRP) in human serum or plasma. Uses near-infrared particle immunoassay rate turbidimetry; anti-CRP antibody-coated particles bind to CRP in patient samples to form insoluble aggregates, increasing turbidity. Operated on SYNCHRON LX 20 PRO or UniCel DxC 600/800 systems by laboratory personnel. Output is a quantitative CRP concentration value. Healthcare providers use results to assess inflammation, stratify cardiovascular disease risk, and determine prognosis for recurrent events in coronary syndrome patients. Benefits include objective clinical data for patient management and risk stratification.

Clinical Evidence

Bench testing only. Method comparison study (n=269) against Dade Behring CardioPhase hsCRP showed slope 1.048, intercept 0.024, r=0.9899. Imprecision studies (n=80 per level) demonstrated within-run CVs of 1.6-3.1% and total CVs of 2.8-5.3% across three concentration levels.

Technological Characteristics

Near-infrared particle immunoassay; rate turbidimetry. Reagent uses anti-CRP antibody-coated particles (goat and mouse antibodies). Liquid stable formulation. Calibration via SYNCHRON Systems CAL 5 Plus. Designed for use on automated SYNCHRON LX 20 PRO and UniCel DxC 600/800 clinical chemistry analyzers.

Indications for Use

Indicated for quantitative determination of C-Reactive Protein (CRP) in human serum or plasma. Used as an aid in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Indicated for identification and stratification of individuals at risk for future cardiovascular disease and as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

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

• Dade Behring CardioPhase hsCRP (K033908)
• Synchron Systems High Sensitivity CRPH Reagent (K010597)

Submission Summary (Full Text)

{0}------------------------------------------------

K070626

## Summary of Safety & Effectiveness SYNCHRON® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent

#### 1.0 Submitted By:

Tara Viviani Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

MAY - 4 2007

#### 2.0 Date Submitted:

March 2, 2007

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent

#### 3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket Number/<br>(Product Code) |
|--------------------------------------------------------------|------------------------------------------------------|-------------------------|----------------------------------|
| Synchron Systems<br>High Sensitivity Cardiac<br>CRPH Reagent | Dade Behring<br>CardioPhase hsCRP | Dade Behring<br>Inc.* | K033908<br>(NQD) |
| Synchron Systems<br>High Sensitivity Cardiac<br>CRPH Reagent | Synchron Systems<br>High Sensitivity<br>CRPH Reagent | Beckman<br>Coulter, Inc | K010597<br>(DCK) |

*Dade Behring Inc. (Newark, DE)

#### 5.0 Description:

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry. SYNCHRON® System(s) CRPH reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity.

#### 6.0 Intended Use:

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX 20 PRO System. UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.

## Clinical Significance:

Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes. CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Beckman Coulter, Inc., Section 510(k) Notification

SYNCHRON® System High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, SYN Cardiac CRPH Summary of Safety final.doc, March 2007

{1}------------------------------------------------

#### 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| | Similarities | |
|-------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Synchron Cardiac<br>CRPH<br>Reagent | Intended Use | Same as<br>Dade Behring<br>CardioPhase hsCRP |
| | Use of Latex particle<br>technology | Same as<br>Dade Behring CardioPhase hsCRP and<br>Synchron CRPH |
| | Liquid stable reagent | The formulation is identical to LX System CRPH<br>Reagent. |
| | Single point adjusted<br>Calibration model | Same as LX System CRPH Reagent |
| | Differences | |
| Synchron Cardiac<br>CRPH Reagent | Antibody source | SYNCHRON Cardiac CRPH uses goat and<br>mouse while the Dade Behring Kit uses mouse<br>only. |
| | Initial dilution range | SYNCHRON Cardiac CRPH initial dilution range<br>covers from 0.02 to 8.0 mg/dL while the Dade<br>Behring Kit covers from 0.31 to 20.0 mg/dL |
| | Extended dilution range | SYNCHRON Cardiac CRPH extended dilution<br>range covers up to 38.0 mg/dL while the Dade<br>Behring Kit covers uses multiple dilutions to<br>cover the range from 0.016 to 1600.0 mg/dL |
| | Calibration model | SYNCHRON Cardiac CRPH uses a different<br>model equation for the predetermined calibration<br>curve than SYNCHRON CRPH |

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

| Analyte | Slope | Intercept | r | n | Predicate Method |
|-------------------------------------------|-------|-----------|--------|-----|------------------------------|
| Synchron Cardiac CRPH<br>(0.2 to 80 mg/L) | 1.048 | 0.024 | 0.9899 | 269 | Behring<br>CardioPhase hsCRP |
| Synchron Cardiac CRPH<br>(0.2 to 10 mg/L) | 1.030 | -0.008 | 0.9910 | 149 | Behring<br>CardioPhase hsCRP |

Method Comparison Study Results

SYNCHRON High Sensitivity Cardiac CRPH Reagent Imprecision Results

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.063 | 0.0019 | 3.1 | 80 |
| Level 2 | 1.368 | 0.0222 | 1.6 | 80 |
| Level 3 | 5.639 | 0.0907 | 1.6 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.063 | 0.0033 | 5.3 | 80 |
| Level 2 | 1.368 | 0.0381 | 2.8 | 80 |
| Level 3 | 5.639 | 0.1823 | 3.2 | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Beckman Coulter, Inc., Section 510(k) Notification

SYNCHRON® System High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, SYN Cardiac CRPH Summary of Safety final.doc, March 2007

{2}------------------------------------------------

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter, Inc. c/o Ms. Tara Viviani Senior Regulatory Affairs Specialist 200 South Kraemer Blvd. M/S /W110 Brea, CA 92822-8000

MAY - 4 2007

Re: k070626

Trade/Device Name: Synchron® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system. Regulatory Class: Class II Product Code: NQD Dated: March 2, 2007 Received: March 6, 2007

Dear Ms. Viviani:

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).

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

{3}------------------------------------------------

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 1egally marketed predicate device results in a classification for your device and thus, permits 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 from me [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Jéan 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

{4}------------------------------------------------

# Indications for Use

K070626 510(k) Number (if known):

Device Name:

SYNCHRON® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH)

Reagent

Indications for Use:

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX® PRO System, UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma bv rate turbidimetry.

## Clinical Significance:

Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis 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 807 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)

ion Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

Page 1 of 1

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® System High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, SYN Cardiac CRPH510K_Section1.doc, March 2007

10