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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the N Antiserum to Human Transferrin device:

Acceptance Criteria and Device Performance Study for N Antiserum to Human Transferrin

The document describes the performance characteristics of the N Antiserum to Human Transferrin, primarily focusing on correlation and precision studies for urine samples.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation	Correlation Coefficient (r)	High (close to 1)	0.99
	Y-intercept	Close to 0	0.53
	Slope	Close to 1	1.01
Precision (Intra-assay)	%CV Range	Low percentage	2.52 to 5.86
Precision (Inter-assay)	%CV Range	Low percentage	1.22 to 7.46

Note: The document does not explicitly state "acceptance criteria" values. The values listed under "Acceptance Criteria (Implicit)" are inferred from general expectations for good performance in comparative and precision studies for diagnostic assays.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 53 urine samples.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a German manufacturer, the samples could be from Germany or elsewhere, and the study design (retrospective vs. prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The concept of "experts" to establish ground truth in the context of this device (an immunoassay for transferrin) is not directly applicable in the same way as for image-based diagnostics. For this type of device, the "ground truth" or reference method is typically the comparator device, which itself is a validated assay. The study compares the new device's measurements against these reference measurements. There's no mention of a ground truth panel established by human experts in this document.

4. Adjudication Method for the Test Set

Not applicable. The study is a quantitative comparison between two laboratory assays, not requiring human adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices where multiple human readers interpret cases. The N Antiserum to Human Transferrin is a laboratory reagent for an immunoassay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented are standalone performance evaluations of the N Antiserum to Human Transferrin Reagent when used with Behring Nephelometer Systems. The performance (correlation and precision) is inherent to the reagent and instrument system, operating without direct human interpretation of individual results beyond running the assay and reading the quantitative output.

7. Type of Ground Truth Used

The "ground truth" for the comparative studies was established by measurements from the legally marketed predicate device, Beckman Transferrin (TRF) Reagent. For the precision studies, the ground truth is essentially the inherent variability of the assay itself under controlled conditions.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. For an immunoassay, the development often involves method optimization and validation, but not typically a distinct "training set" in the machine learning sense. The provided data relates to performance testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as a distinct training set (with associated ground truth establishment) is not described or implicitly suggested in the provided submission for this type of device.

Summary

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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 GmbHEmil-von-Behring Strasse 7635041 MarburgGermany
Distributor	Behring Diagnostics Inc.151 University AvenueWestwood. 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

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 (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.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

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510(k) Number (if known): K972840

Device Name:

N Antiserum to Human Transferrin

1.0 27. 1.9 1.0 1.3 1.3 1.4 1.

Indications For Use:

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

0000000

Confidential

Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).