SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR

K021572 · Beckman Coulter, Inc. · DCN · Jul 19, 2002 · Immunology

Device Facts

• Record ID: K021572
• Device Name: SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: DCN · Immunology
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

Device Story

In vitro diagnostic reagent kit for quantitative determination of C-reactive protein (CRP) in human serum and plasma; utilizes rate turbidimetry with latex particle technology; reagents are liquid-stable; designed for use on Beckman Coulter SYNCHRON CX and LX clinical chemistry systems; operated by laboratory personnel; output is a quantitative CRP concentration value; results assist clinicians in evaluating patient stress, trauma, infection, inflammation, and surgical recovery.

Clinical Evidence

Bench testing only. Method comparison studies performed on 132 (CX) and 143 (LX) samples showed high correlation (R=0.996 and 0.998 respectively) against predicate. Imprecision studies (n=80 per level) demonstrated total CVs ranging from 1.60% to 3.45% across measuring ranges.

Technological Characteristics

Latex particle-enhanced rate turbidimetric immunoassay; liquid-stable reagents; mouse/goat antibody source; detection wavelength 600 nm; compatible with SYNCHRON CX and LX automated chemistry analyzers.

Indications for Use

Indicated for quantitative determination of human C-reactive protein (CRP) in human serum and plasma to aid in evaluation of stress, trauma, infection, inflammation, and surgery.

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

• SYNCHRON LX Systems CRPH Reagent (K010597)
• SYNCHRON Systems CRP Calibrator (K910535)

Submission Summary (Full Text)

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16021572

# JUL 1 9 2002

### 510(k) Summary SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator

#### 1.0 Submitted By:

Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

May 13, 2002

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent SYNCHRON Systems CX® C-RP Calibrator

#### 3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270) Primary Calibrator (21 CFR § 862.1150)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------------------|--------------------------------------|---------------------------|------------------|
| SYNCHRON® Systems<br>C-RP Reagent | SYNCHRON LX®<br>Systems CRPH Reagent | Beckman Coulter,<br>Inc.* | K010597 |
| SYNCHRON Systems<br>CX® C-RP Calibrator | SYNCHRON Systems<br>CRP Calibrator | Beckman Coulter, Inc. | K910535 |

*Beckman Coulter, Inc., Brea, CA

### 5.0 Description:

The SYNCHRON Systems C-RP reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/54/5PRO, CX7/7RTS/7/2/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.

#### 6.0 Intended Use:

C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

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#### 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 |
|--------------|----------------------------------|---------------------------------------------------------------------------------|
| C-RP Reagent | Intended Use | Same as Beckman Coulter<br>SYNCHRON LX Systems High<br>Sensitivity CRPH Reagent |
| | Use of Latex particle technology | |
| | Sample Type | |
| | Antibody source (mouse, goat) | |
| | Liquid-stable reagents | |
| | Differences | |
| | Detection Wavelength | C-RP: 600 nm<br>CRPH: 910 nm |
| | Platform | C-RP: All CX and LX models<br>CRPH: LX PRO models only |
| | Initial Measuring Range | C-RP: 0.20 to 25 mg/dL (CX)<br>0.10 to 25 mg/dL (LX)<br>CRPH: 0.02 to 8 mg/dL |
| | Extended Measuring Range | C-RP: up to 50 mg/dL<br>CRPH: up to 38 mg/dL |
| | Sensitivity | C-RP: 0.20 mg/dL (CX),<br>0.10 mg/dL (LX)<br>CRPH: 0.02 mg/dL |

#### 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, linearity, and imprecision experiments.

| SYNCHRON Systems C-RP Method Comparison Study Results | | |
|-------------------------------------------------------|--|--|
| | | |

| Candidate Method | Platform | Slope | Intercept | R | n | Predicate Method |
|--------------------------|----------|-------|-----------|-------|-----|-----------------------------------|
| SYNCHRON<br>Systems C-RP | CX | 1.007 | 0.05 | 0.996 | 132 | Beckman Coulter |
| Reagent | LX | 1.033 | 0.01 | 0.998 | 143 | SYNCHRON LX Systems<br>CRPH Assay |

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.49 | 0.014 | 2.77 | 80 |
| Level 2 | 5.40 | 0.063 | 1.17 | 80 |
| Level 3 | 13.45 | 0.210 | 1.56 | 80 |
| Level 4 | 23.99 | 0.598 | 2.49 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.49 | 0.017 | 3.45 | 80 |
| Level 2 | 5.40 | 0.086 | 1.60 | 80 |
| Level 3 | 13.45 | 0.287 | 2.13 | 80 |
| Level 4 | 23.99 | 0.624 | 2.60 | 80 |

### SYNCHRON LX System C-RP Estimated Imprecision

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.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92822-8000

JUL 1 9 2002

k021572 Re:

Trade/Device Name: SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator Regulation Number: 21 CFR § 866.5270 and 21 CFR § 862.1150 Regulation Name: C-Reactive Protein Immunological Test System and Primary Calibrator Regulatory Class: II Product Code: DCN, JIS Dated: May 13, 2002 Received: May 14, 2002

Dear Ms. Tang:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set

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## Page 2

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator

Indications for Use:

C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX® Systems and CX® C-RP Calibrator on SYNCHRON CX® Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples by rate turbidimetry. Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

KO21572

CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-Reactive Protein (C-RP) Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1/Reeve for E. Altaie

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number _

Prescription Use
(per 21 CFR 801.109)

OR

. '

Over-the-Counter Use Optional Format 1-2-96