SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR

K971788 · Beckman Instruments, Inc. · DHR · Jun 3, 1997 · Immunology

Device Facts

• Record ID: K971788
• Device Name: SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
• Applicant: Beckman Instruments, Inc.
• Product Code: DHR · Immunology
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma. The SYNCHRON CX® Systems RF Calibrator, a six level calibrator set, in conjunction with SYNCHRON® Systems RF Reagent, is intended for use on SYNCHRON CX Systems for the calibration of Rheumatoid Factor.

Device Story

The SYNCHRON Systems Rheumatoid Factor (RF) Reagent is an in vitro diagnostic reagent used on Beckman SYNCHRON Systems. It utilizes latex particles coated with human IgG to detect rheumatoid factor in human serum or plasma samples. The device operates via a turbidimetric method, measuring the concentration of rheumatoid factor through immunochemical reaction. It is intended for use in clinical laboratory settings by trained personnel. The output is a quantitative concentration value (IU/mL) provided to clinicians to assist in the diagnosis of rheumatoid arthritis. The system includes a six-level calibrator set for system calibration.

Clinical Evidence

Bench testing only. Method comparison study between SYNCHRON RF Reagent and IMMAGE RF Reagent (N unspecified) showed a slope of 0.982, intercept of -3.43, and correlation coefficient (r) of 0.953. Imprecision studies (N=80 per level) demonstrated within-run %C.V. ranging from 2.2% to 5.6% and total imprecision %C.V. ranging from 2.8% to 11.5% across three concentration levels.

Technological Characteristics

Reagents consist of latex particles coated with human IgG. Measurement principle is turbidimetric. Designed for use on Beckman SYNCHRON Systems. Analytical range: 20 to 800 IU/mL. Storage: 2-8°C.

Indications for Use

Indicated for the quantitative determination of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Test System (K963048)

Submission Summary (Full Text)

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K971788

Summary of Safety & Effectiveness SYNCHRON® Systems Rheumatoid Factor (RF) Reagent

V - 3 1997

#### Submitted By: 1.0

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:

13 May 1997

#### 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON® Systems Rheumatoid Factor (RF) Reagent SYNCHRON CX® Systems RF Calibrator

### 3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775) Calibrator (21 CFR 862.1150)

#### 4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Test System K963048

#### 5.0 Description:

The SYNCHRON Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human meumatoid factor by rate nephelometry.

#### 6.0 Intended Use:

The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.

The SYNCHRON CX® Systems RF Calibrator, a six level calibrator set, in conjunction with SYNCHRON® Systems RF Reagent, is intended for use on SYNCHRON CX Systems for the calibration of Rheumatoid Factor.

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Rheumatoid Factor (RF) Reagent Summary of Safety & Effectiveness

### 7.0 Comparison to Predicate(s):

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 RF<br>Reagent | Latex particles coated<br>with human IgG | |
| SYNCHRON<br>Systems RF<br>Reagent | Shelf-life of 24 months<br>(stored at 2-8°C) | Same as IMMAGE System RF Reagent |
| SYNCHRON<br>Systems RF<br>Reagent | Initial analytic range of<br>20 to 800 IU/mL | |
| DIFFERENCES | | |
| SYNCHRON<br>Systems RF<br>Reagent | Calibrator | The SYNCHRON uses a six level system<br>calibration while the IMMAGE uses a single<br>cal point update |
| SYNCHRON<br>Systems RF<br>Reagent | Methodology | The SYNCHRON Systems RF utilizes a<br>turbidimetric method while the IMMAGE<br>System RF utilizes a nephelometric 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. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the SYNCHRON RF Reagent to the IMMAGE System RF Reagent.

### Method Comparison Study Results SYNCHRON RF Reagent vs. IMMAGE RF Reagent

| Analyte | Slope | Intercept | r | Predicate |
|---------|-------|-----------|-------|-----------|
| RF | 0.982 | -3.43 | 0.953 | IMMAGE RF |

## Estimated SYNCHRON RF Reagent Imprecision

| Sample | Mean (IU/mL) | S.D. (IU/mL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 68.3 | 3.79 | 5.6 | 80 |
| Level 2 | 220.7 | 5.07 | 2.3 | 80 |
| Level 3 | 582.2 | 12.9 | 2.2 | 80 |
| Total Imprecision | | | | |
| Level 1 | 68.3 | 7.84 | 11.5 | 80 |
| Level 2 | 220.7 | 6.46 | 2.9 | 80 |
| Level 3 | 582.2 | 16.4 | 2.8 | 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.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 3 1997

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

Re: K971788

Trade Name: SYNCHRON® Systems Rheumatoid Factor (RF) Reagent Regulatory Class: II Product Code: DHR Dated: May 13, 1997 Received: May 14. 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Register.

Please note: this response to vour premarket notification submission does not affect any obligation vou 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.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-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].

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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

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page

510(k) Number (if known):

Device Name: SYNCHRON® Systems Rheumatoid Factor (RF) Reagent

Indications for Use: - - - - -

The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent , in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.

Rheumatoid factor immunological test system(21 CFR 866.5775)

(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure bv immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

(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)

Retur E. Maluss

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .

Prescription Use ﺑﻠﻨﺪﯼ (per 21 CFR 801.109)

OR

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