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 Description

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.

AI/ML Overview

The N Antiserum to Human Albumin underwent studies to demonstrate its performance, specifically focusing on its correlation with a legally marketed predicate device and its precision.

1. Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Correlation	Not explicitly stated, but typically a high correlation coefficient (e.g., >0.95) with the predicate device is sought for quantitative assays.	Correlation Coefficient (r): 0.99 (with Beckman micro Albumin (MA) Reagent)
		Y-intercept: -0.73
		Slope: 1.12
Intra-assay Precision (%CV)	Not explicitly stated, but typically low %CV values are desired for good precision (e.g., <10% for clinical assays).	2.21 to 3.94%
Inter-assay Precision (%CV)	Not explicitly stated, but typically low %CV values are desired for good precision (e.g., <10% for clinical assays).	1.77 to 5.01%

2. Sample Size and Data Provenance for Test Set

Sample Size for Correlation Study: 79 urine samples were used for the comparative study measuring albumin.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device's performance assessment appears to be based on comparative measurements against a predicate device and internal precision studies, rather than expert consensus on diagnostic images or clinical interpretations.

4. Adjudication Method for Test Set

Not applicable. As noted above, the assessment of performance is based on quantitative measurements and statistical analysis, not expert adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic reagent, not a device that involves human readers interpreting diagnostic data.

6. Standalone Performance Study

Yes, a standalone performance study was done for precision. The N Antiserum to Human Albumin was evaluated for intra-assay and inter-assay precision on the Behring Nephelometer. This demonstrates the algorithm's (or in this case, the reagent's analytical method's) inherent performance characteristics.
The correlation study also assessed the standalone performance by comparing its results directly to a predicate device, effectively showing its performance in measuring albumin.

7. Type of Ground Truth Used

For the correlation study: The "ground truth" was established by the measurements obtained from the predicate device, the Beckman micro Albumin (MA) Reagent. The assumption is that the predicate device provides accurate measurements of albumin.
For the precision studies: The "ground truth" is the inherent variability of the assay itself under repeat measurements, assessed using statistical methods (%CV). There isn't an external "ground truth" in the same sense as pathology for an imaging device.

8. Sample Size for Training Set

Not applicable. This is an in vitro diagnostic reagent, not an AI/ML algorithm that requires a training set of data. The performance is based on the chemical and immunological properties of the reagent and the measurement capabilities of the nephelometer system.

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set was used for this type of device.

Summary

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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.151 University AvenueWestwood, MA 02090617-320-3000
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 .

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 (770)488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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

11
1C

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)

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 866.5040 Albumin immunological test system.

(a)
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.(b)
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.