SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT

K971958 · Beckman Instruments, Inc. · DDG · Aug 20, 1997 · Immunology

Device Facts

• Record ID: K971958
• Device Name: SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DDG · Immunology
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Device Story

The SYNCHRON LX Systems Transferrin (TRFN) Reagent is an in vitro diagnostic reagent used on Beckman SYNCHRON LX20 clinical chemistry analyzers. It utilizes an immunoturbidimetric principle where the reagent reacts with human transferrin in serum or plasma samples to form antigen-antibody complexes. The analyzer measures the resulting turbidity at 340 nm at 37°C. The system is operated by laboratory personnel in a clinical setting. The output is a quantitative concentration of transferrin (mg/dL), which assists clinicians in diagnosing malnutrition, inflammation, infection, renal function, and iron deficiency anemia. The device includes an automated antigen excess check to prevent inaccurate reporting of high concentrations.

Clinical Evidence

Bench testing only. Method comparison study (n=80) between SYNCHRON LX TRFN and ARRAY System TRFN showed a slope of 1.041, intercept of -20.7 mg/dL, and correlation coefficient (r) of 0.9844. Within-run imprecision (%C.V.) ranged from 1.34% to 1.47% across three levels (135.7–303.5 mg/dL). Stability data supports a 24-month shelf-life, 14-day calibration stability, and 60-day on-board stability.

Technological Characteristics

Immunoturbidimetric assay; reaction at 37°C; endpoint detection at 340 nm. Reagent packaged in polystyrene cartridges. Designed for use on SYNCHRON LX20 clinical chemistry analyzers. Automated antigen excess detection. No specific material standards or software architecture details provided.

Indications for Use

Indicated for the quantitative determination of human transferrin in serum or plasma to aid in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function, and red blood cell disorders such as iron deficiency anemia.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• Beckman Transferrin (TRFN) Reagent (K780913)

Submission Summary (Full Text)

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K971958

AUG 20 1997

## Summary of Safety & Effectiveness SYNCHRON LX™ Systems Transferrin (TRFN) Reagent

#### 1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

21 May 1997

#### 3.0 Device Name(s):

## 3.1 Proprietary Names

SYNCHRON LX™ Systems Transferrin (TRFN) Reagent

## 3.2 Classification Names

Transferrin immunological test system (21 CFR 866.5880)

#### 4.0 Predicate Device(s):

| SYNCHRON LX<br>Reagents | Predicate | Predicate<br>Company | Docket<br>Number |
|-------------------------------|------------------------------------------|------------------------------|------------------|
| Transferrin (TRFN)<br>Reagent | Beckman<br>Transferrin<br>(TRFN) Reagent | Beckman<br>Instruments, Inc. | K780913 |

#### 5.0 Description:

The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.

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Beckman Instruments, Inc., Section 510(K) Notification SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Summary of Safety & Effectiveness

#### 6.0 Intended Use:

The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

#### 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 LX Systems<br>(TRFN) Reagent | Intended use | Same as the ARRAY System<br>TRFN reagent quantitative<br>determination of human transferrin |
| | Chemical reaction | Same principle as the ARRAY<br>System TRFN reagent; formation<br>of antigen-antibody complexes |
| | Antibody | Same source, antibody,<br>processing, and buffer as the<br>ARRAY System TRFN reagent |
| | Calibration | Same as the ARRAY System<br>TRFN reagent; single point update<br>of manufacturer determined<br>calibration curve |

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| Reagent | Aspect<br>/Characteristic | Comments |
|------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| SYNCHRON LX<br>Systems (TRFN)<br>Reagent | Methodology | The SYNCHRON LX reads turbidimetrically and the<br>ARRAY System reads nephelometrically |
| | Measurement method | The SYNCHRON LX runs the reaction at 37°C and<br>reads an endpoint at 340 nm, where the ARRAY<br>System runs at 26.5°C and reads the rate of increase<br>in light scatter at 670 nm |
| | Range expansion | The SYNCHRON LX TRFN reagent measures<br>transferrin concentrations at the initial range of 75 -<br>800 mg/dL; while the ARRAY TRFN reagent<br>measures transferrin concentrations at the initial range<br>of 75-800 mg/dL and expanded range of 12.5 - 4,500<br>mg/dL |
| | Type of specimen | The SYNCHRON LX TRFN reagent measures<br>transferrin concentrations in serum or plasma<br>samples; while the ARRAY Systems TRFN reagent<br>measures transferrin concentrations in serum (plasma<br>samples are not recommended) or urine samples. |
| | Antigen excess<br>checking | The SYNCHRON LX TRFN reagent was designed so<br>that high antigen concentrations will not report in<br>range; the ARRAY System adds extra antibody to<br>observe for additional activity |
| | Packaging | The SYNCHRON LX TRFN reagent is packaged in<br>polystyrene cartridges; the ARRAY System TRFN<br>reagent is packaged in glass bottles |

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON LX™ Systems Transferin (TRFN) Reagent Summary of Safety & Effectiveness

#### Summary of Performance Data: 8.0

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, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRFN Transferrin (on ARRAY) Reagent to the SYNCHRON LX Transferrin (TRFN) Reagent.

> Method Comparison Study Results SYNCHRON LX Transferrin (TRFN) Reagent vs. Beckman TRFN Transferrin Reagent (on ARRAY)

| Reagent<br>(Analyte) | Slope | Intercept<br>(mg/dL) | r | n | Predicate Method |
|--------------------------------------------------|-------|----------------------|--------|----|----------------------------------------------------------------|
| The SYNCHRON LX<br>Transferrin (TRFN)<br>Reagent | 1.041 | -20.7 | 0.9844 | 80 | Beckman's TRFN<br>Transferrin Reagent on the<br>ARRAY® Systems |

### Stability Study Results

| Reagent | Product Claim |
|-------------------------------------------|-----------------------------------------------------------------------------------|
| SYNCHRON LX Transferrin (TRFN)<br>Reagent | 24 month shelf-life<br>14 day calibration stability<br>60 days on-board stability |

Estimated Within-Run Imprecision

| Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N |
|----------------------------------------|-----------------|-----------------|-------|----|
| SYNCHRON LX Transferrin (TRFN) Reagent | | | | |
| Level 1 | 135.7 | 2.00 | 1.47 | 80 |
| Level 2 | 218.6 | 2.95 | 1.35 | 80 |
| Level 3 | 303.5 | 4.08 | 1.34 | 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Senior Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

AUG 20 1997

K971958/S1 Re: Trade Name: SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Regulatory Class: II Product Code: DDG Dated: July 31, 1997 Received: August 5, 1997

Dear Ms. Stockert:

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, Druq, 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 Regulation (QS) for Medical Devices: General requlation (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 GMF regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Piease 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.

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Page 2

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].

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 Sutman

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):

SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Device Name:

Indications for Use: .........................................................................................................................................................

The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assav is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.

21 CFR 866.5880 Transferrin immunological test system

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number

| Prescription Use<br>(per 21 CFR 801.109) | OR | Over-the-Counter Use<br>Optional Format 1-2-96 |
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