SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT

K974050 · Beckman Instruments, Inc. · DCK · Nov 24, 1997 · Immunology

Device Facts

• Record ID: K974050
• Device Name: SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DCK · Immunology
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent, in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.

Device Story

The SYNCHRON Systems CRP Reagent is an in vitro diagnostic reagent used on Beckman SYNCHRON Systems to measure C-reactive protein concentration. The device utilizes a turbidimetric rate nephelometry method to quantify CRP levels in patient serum or plasma samples. It is intended for use by clinical laboratory professionals. The system processes samples to produce a quantitative concentration value, which assists healthcare providers in evaluating the extent of tissue injury. The device benefits patients by providing objective data for clinical assessment of inflammatory states or tissue damage.

Clinical Evidence

Bench testing only. Performance data includes method comparison studies using Deming regression analysis for various anticoagulants (Lithium Heparin, Sodium Heparin, EDTA) showing high correlation (r=0.967 to 0.989). Imprecision studies (N=80 per level) demonstrated within-run %C.V. ranging from 1.14% to 4.46% and total imprecision %C.V. ranging from 3.56% to 5.49% across three concentration levels.

Technological Characteristics

Immunological test system for CRP quantification. Utilizes turbidimetric rate nephelometry. Reagent shelf-life is 24 months at 2-8°C. System uses a five-level calibration set. Designed for use on Beckman SYNCHRON Systems.

Indications for Use

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

• IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent (K963061)

Submission Summary (Full Text)

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

K974050

# BECKMAN

NOV 2 4 1997

## Summary of Safety & Effectiveness SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

#### 1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

October 23, 1997

#### 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

3.2 Classification Names

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

#### 4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent K963061

#### 5.0 Description:

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human C-reactive protein by rate nephelometry.

#### 6.0 Intended Use:

The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent , in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.

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

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

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

| Reagent | Aspect/Characteristic | Comments |
|------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON<br>Systems CRP<br>Reagent | Sample types<br>(serum/plasma) | Same as IMMAGE System CRP Reagent |
| SYNCHRON<br>Systems CRP<br>Reagent | Shelf-life of 24 months<br>(stored at 2-8°C) | Same as IMMAGE System CRP Reagent |
| SYNCHRON<br>Systems CRP<br>Reagent | Antibody | Same as IMMAGE System CRP Reagent |
| DIFFERENCES | | |
| SYNCHRON<br>Systems CRP<br>Reagent | Calibrator | The SYNCHRON uses a five level system<br>calibration while the IMMAGE uses a single<br>cal point update. |
| SYNCHRON<br>Systems CRP<br>Reagent | Methodology | The SYNCHRON Systems CRP utilizes a<br>turbidimetric method while the IMMAGE<br>System CRP utilizes a nephelometric<br>method. |

#### 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.

# Method Comparison for CRP Reagent

| 145 SUSSAFE SERVACETRY SERVED SERIE CONFECT STARE<br>******************************************************************************************************************************************************************************<br><br><br><br><br><br>CARS COLLECT<br><br>100 4 100 000 100 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 0000 0000 0000 00000000000000000 | . Авидеть авинания светство в присатериана терика<br>. I am a f a s a program a participant a parties and proposition in the finities and the maint of the maint of the maint of the maint of the maintent of the maint of the main<br>Miller = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =<br><br>4. 10700 11/24 11/24 12 2000 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100<br>******************************************************************************************************************************************************************************<br><br>TANKPARENERER DOGREDARD<br>.<br>. A B R<br>A Book Andrew Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book Book | waangabatakaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa<br><br>100 Bir All La<br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br> | . The a sunt of the other frequent of the serves in a<br><br>. Runna den Bandade<br>A CAARLE E EXERTIES .<br>SANSFORD SALES BASE<br>MAANAGE ER FETAAL<br><br>.<br> | <br>**********************<br><br><br>.<br><br><br>Annesesbably on Bankanopribal | THE OWNER OF<br>---------<br> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------|
| | | | | | A Children Call |

# Serum vs Plasma Study Summary

| Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis (mg/dL) |
|-----------------|-------------------------------|------------------------------------|
| Lithium Heparin | 14 Units/mL | $Y = 1.042X - 0.45; r = 0.977$ |
| Sodium Heparin | 14 Units/mL | $Y = 0.994X - 0.07; r = 0.989$ |
| EDTA | 1.5 mg/mL | $Y = 0.992X - 0.20; r = 0.967$ |

# Estimated SYNCHRON CRP Reagent Imprecision

| Sample | Mean (IU/mL) | S.D. (IU/mL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 1.03 | 0.05 | 4.46 | 80 |
| Level 2 | 4.06 | 0.06 | 1.58 | 80 |
| Level 3 | 7.09 | 0.08 | 1.14 | 80 |
| Total Imprecision | | | | |
| Level 1 | 1.03 | 0.06 | 5.49 | 80 |
| Level 2 | 4.06 | 0.18 | 4.49 | 80 |
| Level 3 | 7.09 | 0.25 | 3.56 | 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions NOV 2 4 1997 Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

Re: K974050 SYNCHRON® System C-Reactive Protein (CRP) Reagent Trade Name: Requlatorv Class: II Product Code: DCK Dated: October 23, 1997 Received: October 24, 1997

Dear Ms. Hellie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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

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

510(k) Number (if known): K974050

Device Name: SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

Indications for Use:

The SYNCHRON® Systems C-Reactive Protein (CRP) Roagent, In conjunction with the SYNCHRON CX® CRP Calibrator Set. Is intended for the quantitative determination of C-reactive protein concentration in serum or plaema.

21 CFR 866.5270 C-reactive protein immunological test system.

(a) 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. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. . . . - - --- ---- -----------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) Classification. Class II (performance standards)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off

beratory Devices 5100c) Nowel

Prescription Use
(per 21 CFR 801.109)

OR

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