N ANTISERUM TO HUMAN TRANSFERRIN

K972840 · Behring Diagnostics, Inc. · DDG · Oct 17, 1997 · Immunology

Device Facts

• Record ID: K972840
• Device Name: N ANTISERUM TO HUMAN TRANSFERRIN
• Applicant: Behring Diagnostics, Inc.
• Product Code: DDG · Immunology
• Decision Date: Oct 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

Device Story

N Antiserum to Human Transferrin is an in vitro diagnostic reagent for use with Behring Nephelometer Systems. It detects transferrin in human serum and urine samples. Principle of operation: proteins in samples form immune complexes with specific antibodies; these complexes scatter light; scattered light intensity is proportional to protein concentration. Results are determined by comparing sample light intensity against a standard of known concentration. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing iron deficiency, iron overload, and glomerular defects.

Clinical Evidence

Bench testing only. Comparative study of 53 urine samples (range 2.44–300.60 mg/L) between subject device and predicate showed a correlation coefficient of 0.99, slope of 1.01, and v-intercept of 0.53. Precision evaluated per NCCLS EP5-T; intra-assay %CV ranged from 2.52 to 5.86; inter-assay %CV ranged from 1.22 to 7.46.

Technological Characteristics

In vitro diagnostic reagent utilizing immunonephelometry. Operates by measuring light scattering from antigen-antibody complexes. Designed for use with Behring Nephelometer Systems. No specific materials of construction or software architecture details provided.

Indications for Use

Indicated for the measurement of transferrin in human serum and urine as an aid in the diagnosis of latent and manifest iron deficiency, iron overload, and glomerular defects.

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 (TRF) Reagent (K926272)

Submission Summary (Full Text)

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# OCT 1 7 1997

# 510(k) SUMMARY FOR N ANTISERUM TO HUMAN TRANSFERRIN

Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:

| Manufacturer | Behringwerke GmbH<br>Emil-von-Behring Strasse 76<br>35041 Marburg<br>Germany |
|--------------|------------------------------------------------------------------------------|
| Distributor | Behring Diagnostics Inc.<br>151 University Avenue<br>Westwood. MA 02090 |

Contact Person: Ruth Forstadt

Date of Preparation: July 31, 1997

#### Name/ Classification: 2 . Device

N Antiserum to Human Transferrin

FDA has classified N Antiserum to Human Transferrin into Class II (866.5880).

617-320-3000

### 3 . ldentification of the legally marketed device:

Beckman Transferrin(TRF) Reagent -K926272

#### 4 . Device Description: Proposed

The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine.

In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

000023

Confidential

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### Proposed Device Intended Use: 5 .

N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems for the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

## Medical device to which equivalence is claimed and comparison 6. information.

The N Antiserum to Human Transferrin is substantially equivalent in intended use and results to the Beckman Transferrin (TRF) Reagent, in that both methods measure human transferrin in serum and urine.

#### Performance 7 . Proposed Device Characteristics:

## Correlation:

Comparative studies to measure transferrin in urine using N Antiserum to Human Transferrin and Beckman Transferrin (TRF) Reagent were conducted. In 53 urine samples, ranging from 2.44 to 300.60 mg/L, the correlation coefficient was 0.99, the v-intercept was 0.53 and the slope was 1.01.

## Precision:

The N Antiserum to Human Transferrin Reagent was evaluated for the precision of the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.52 to 5.86, and interassay precision %CV ranged from 1.22 to 7.46.

**CONFIDENTIAL**

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Ruth Forstadt Regulatory Affairs Associate Behring Diagnostics, Inc. 151 University Avenue Westwood, Massachusetts 02090

OCT ! 7 1997

Re: K972840 Trade Name: N Antiserum to Human Transferrin Requlatory Class: II Product Code: DDG Dated: July 31, 1997 Received: Auqust 1, 1997

Dear Ms. Forstadt:

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 Regulation (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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity cateqorization. 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 requlation 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.qov/cdrh/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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Behring Diagnostics Inc. N Antiserum to Human Transferrin 510(k) Notification

> of _ Page

510(k) Number (if known): K972840

Device Name:

N Antiserum to Human Transferrin

1. 1.0 27. 1.9 1.0 1.3 1.3 1.4 1.

Indications For Use:

N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madni

(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)

0000000

Confidential