N ANTISERUM TO HUMAN ALBUMIN

K972929 · Behring Diagnostics, Inc. · DCF · Oct 20, 1997 · Immunology

Device Facts

• Record ID: K972929
• Device Name: N ANTISERUM TO HUMAN ALBUMIN
• Applicant: Behring Diagnostics, Inc.
• Product Code: DCF · Immunology
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

Device Story

In vitro diagnostic reagent; used with Behring Nephelometer Systems. Input: human serum, cerebrospinal fluid, or urine samples. Principle: proteins in sample form immune complexes with specific antibodies; complexes scatter light beam; scattered light intensity proportional to protein concentration. Output: quantitative albumin concentration determined by comparison with known standard. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing kidney and intestinal diseases.

Clinical Evidence

Bench testing only. Comparative study of 79 urine samples measured by subject device and predicate. Results: correlation coefficient 0.99, y-intercept -0.73, slope 1.12. Precision evaluated per NCCLS EP5-T protocol; intra-assay %CV 2.21-3.94, inter-assay %CV 1.77-5.01.

Technological Characteristics

In vitro diagnostic reagent; nephelometric assay. Utilizes specific antibodies to form immune complexes with human albumin. Designed for use with Behring Nephelometer Systems. No specific materials of construction or software algorithm details provided.

Indications for Use

Indicated for the measurement of albumin in human serum, cerebrospinal fluid, and urine as an aid in the diagnosis of kidney and intestinal diseases.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Beckman micro Albumin (MA) Reagent (K895883)

Submission Summary (Full Text)

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K972929

Behring Diagnostics Inc. N Antiserum to Human Albumin 510(k) Notification

OCT 20 1997

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

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

Manufacture

Behringwerke GmBH Postfach 1140 35001 Marburg Germany

| Distributor | Behring Diagnostics Inc.<br>151 University Avenue<br>Westwood, MA 02090<br>617-320-3000 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Ruth Forstadt |
| Date of Preparation: | July 7, 1997 |

#### Name/ Classification: 2 . Device

N Antiserum to Human Albumin

FDA has classified N Antiserum to Human Albumin into Class II (866.5040).

## 3 . Identification of the legally marketed device:

Beckman micro Albumin(MA) Reagent -K895883

## Proposed Device Description: 4 .

The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid 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.

## 5 . Proposed Device Intended Use:

N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, csf and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

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Behring Diagnostics Inc. N Antiserum to Human Albumin 510(k) Notification

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

The N Antiserum to Human Albumin is substantially equivalent in intended use and results to the Beckman micro Albumin (MA) Reagent, in that both methods measure human albumin in urine.

## Proposed Device Performance Characteristics: 7 .

## Correlation:

Comparative studies to measure albumin in urine using N Antiserum to Human Albumin and Beckman micro Albumin (MA) Reagent were conducted. In 79 urine samples, ranging from 11.51 to 5259.42 mg/L, the correlation coefficient was 0.99, the yintercept was -0.73 and the slope was 1.12.

# Precision:

The N Antiserum to Human Albumin was evaluated for the assay in urine on the Behring Nephelometer. The data analysis protocol was adapted from NCCLS EP5-T. Intra-assay precision %CV ranged from 2.21 to 3.94, and inter-assay precision %CV ranged from 1.77 to 5.01.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 20 1997

Re : K972929 Trade Name: N Antiserum to Human Albumin Regulatory Class : II Product Code: DCF Dated: August 7, 1997 Received: Auqust 8, 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 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 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.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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 Albumin 510(k) Notification

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510(k) Number (if known): K972929

Device Name:_

N Antiserum to Human Albumin

Indications For Use:

N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum. cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Meglem

0 D U SUCNB IS 5 31.0. 11. 211. 211. 2

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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