IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

K983340 · Beckman Coulter, Inc. · DBF · Dec 14, 1998 · Immunology

Device Facts

• Record ID: K983340
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: DBF · Immunology
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® with Immunochemistry System Ferritin Calibrator, is intended for the quantitative determination of femitin in human serum by turbidimetric immunoassay. Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE Immunochemistry Systems for the calibration of ferritin.

Device Story

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Calibrator are used on the IMMAGE® Immunochemistry System to measure ferritin levels in human serum. The system utilizes a turbidimetric immunoassay methodology, specifically Near Infrared Particle Immunoassay (NIPIA), to quantify ferritin. The device requires a 7.5 µL sample volume. The system is operated by laboratory personnel in a clinical setting. The output is a quantitative ferritin concentration, which clinicians use to assess body iron stores and assist in diagnosing conditions such as anemia and hemochromatosis. The device benefits patients by providing an automated, precise measurement of iron storage proteins.

Clinical Evidence

Bench testing only. Method comparison study against the IMx Ferritin predicate (n=116) yielded a slope of 1.059, intercept of -6.5 ng/mL, and r=0.987. Imprecision studies (n=80 per level) showed within-run C.V.s of 2.6%–4.4% and total C.V.s of 3.1%–5.5% across three concentration levels (53.5–397.0 ng/mL).

Technological Characteristics

Turbidimetric immunoassay using Near Infrared Particle Immunoassay (NIPIA) technology. Reagents utilize rabbit polyclonal antibodies. System requires 7.5 µL sample volume. Designed for use on the IMMAGE® Immunochemistry System. Calibration is single-point, linked to a WHO standard.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum to aid in the diagnosis of anemia and hemochromatosis (iron overload).

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• IMx® Ferritin (FER) (K881345)

Submission Summary (Full Text)

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DEC | 4 1998

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## Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Ferritin Reagent

#### 1.0 Submitted By:

Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

21 September 1998

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE® Immunochemistry System Femitin (FER) Reagent IMMAGE® Immunochemistry System Ferritin Calibrator

#### Classification Name 3.2

Ferritin Test System (21 CFR §862.3920) Catibrator (21 CFR 5882.1150)

### 4.0 Predicate Device(s):

| IMMAGE System | Predicate | Manufacturer | Docket Number |
|-----------------------------------------|----------------------|-------------------------------|----------------------|
| IMMAGE System Ferritin<br>(FER) Reagent | IMx®* Ferritin (FER) | Abbott**<br>Laboratories, Inc | K881345 |
| IMMAGE System Ferritin<br>Calibrator | | | (K882233)<br>DIGOXAL |

*Trademark of Abbott Laboratories

** Abbott Laboratories, Abbott Park, IL 60064

#### 5.0 Description:

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.

### 6.0 Intended Use:

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® with Immunochemistry System Ferritin Calibrator, is intended for the quantitative determination of femitin in human serum by turbidimetric immunoassay.

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE Immunochemistry Systems for the calibration of ferritin.

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

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

| IMMAGE System | Aspect/Characteristic | Comments |
|-------------------|-------------------------------------|----------------|
| IMMAGE System FER | Intended use. | |
| Reagent | Reaction temperature of 37° C | Same as Abbott |
| IMMAGE System FER | Human Spleen Origin | IMx Ferritin |
| Calibrator | Calibrator linked to a WHO Standard | |

## SIMILARITIES to the PREDICATE

## DIFFERENCES from the PREDICATE

| IMMAGE<br>System | Aspect/Characteristic | Comments |
|------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| IMMAGE<br>System FER<br>Reagent | IMMAGE FER uses Near Infrared<br>Particle Immunoassay (NIPIA) rate<br>immunoassay methodology | Abbott IMx reagents utilize<br>fluorescence polarization<br>immunoassay |
| | Antibody source for IMMAGE FER is<br>rabbit (polyclonal) | Antiserum sources for IMx<br>Ferritin are rabbit and mouse |
| IMMAGE<br>System FER<br>Calibrator | Calibration | IMMAGE FER uses a single<br>point calibration while IMx is<br>multipoint |
| IMMAGE<br>System FER<br>Sample | IMMAGE System FER requires a<br>sample volume of 7.5 µL | IMx ferritin requires a sample<br>volume of 150µL |

#### 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 and imprecision experiments.

| Analyte | Sample Type | Slope | Intercept (ng/mL) | r | n | Predicate Method |
|-----------------------|-------------|-------|-------------------|-------|-----|------------------|
| IMMAGE<br>FER Reagent | serum | 1.059 | -6.5 | 0.987 | 116 | IMx Ferritin |

# Method Comparison Study Results

## Estimated IMMAGE System Ferritin (FER) Reagent Imprecision

| Sample | Mean (ng/mL) | S.D. (ng/mL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 53.5 | 2.4 | 4.4 | 80 |
| Level 2 | 172.0 | 5.3 | 3.0 | 80 |
| Level 3 | 397.0 | 10.5 | 2.6 | 80 |
| Total Imprecision | | | | |
| Level 1 | 53.5 | 2.9 | 5.5 | 80 |
| Level 2 | 172.0 | 7.1 | 4.1 | 80 |
| Level 3 | 397.0 | 12.4 | 3.1 | 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

2098 Gaither Road

Rockville MD 20850

Food and Drug Administration

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEC | 4 1998 Mr. Richard T. Ross Staff Requlatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000

Re : K983340

> IMMAGE® Immunochemistry System Ferritin (FER) Trade Name: Reagent and IMMAGE® Immunochemistry System Ferritin Calibrator Requlatory Class: II Product Code: DBF Dated: September 21, 1998 September 23, 1998 Received:

Dear Mr. Ross:

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 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). 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.

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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/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 Radioloqical Health

Enclosure

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K983340

page 1 of \$\overline{J}\$

510(k) Number (if known): Not yet assigned-

Device Name:

IMMAGE® Immunochemistry System Ferritin (FER) Reagent

Indications for Use:

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.

Clinical Significance:

Ferritin is the main iron storage protein in the body. The concentration of ferritin is directly proportional to the iron stores in the body. Measurement of ferritin may aid in the diagnosis of anemia and hemochromatosis (Iron overload).

Ferritin (21 CFR §866.5340)

(b) Classification. Class II.

(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 | K983348 |

| Prescription Use<br>(per 21 CFR 801.109) | <img alt="Check" src="check.jpg"/> | OR | Over-the-Counter Use<br>Optional Format 1-2-96 |
|------------------------------------------|------------------------------------|----|------------------------------------------------|
|------------------------------------------|------------------------------------|----|------------------------------------------------|

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page 2 of 2

K983340

510(k) Number (if known):- Not yet assigned

Device Name:

IMMAGE® Immunochemistry Systems Ferritin Calibrator

Indications for Use:

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

Clinical Significance:

Ferritin is the main iron storage protein in the body. The concentration of ferritin is directly proportional to the iron stores in the body. Measurement of ferritin may aid in the diagnosis of anemia and hemochromatosis (Iron overload).

Calibrator (21 CFR §862.1150)

(b) Classification. Class II.

(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
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96