The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNII), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Device Description

N Latex sTfR Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of soluble transferrin receptor (sTfR) in human serum or heparinized human plasma.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Inc. N Latex sTfR Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the N Latex sTfR Reagent primarily focuses on establishing substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria in the traditional sense. The performance characteristics described are used to demonstrate that the device performs comparably to the predicate. Therefore, the "acceptance criteria" can be inferred from what the manufacturer chose to report as sufficient for equivalence.

Performance Characteristic	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (N Latex sTfR Reagent)
Correlation	Strong positive correlation (e.g., r > 0.90) with the predicate device.	r = 0.96 with a commercially available sTfR assay.
Slope (Correlation)	Close to 1.0 (indicating similar overall scale).	0.81
Y-intercept (Correlation)	Close to 0 (indicating similar bias at low concentrations).	-0.19
Inter-assay Precision	Low variability (e.g., < 5% CV).	0.8% to 1.2%
Intra-assay Precision	Low variability (e.g., < 5% CV).	1.4% to 2.1%

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

Test Set Sample Size: 62 samples
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved comparing the N Latex sTfR Reagent to a "commercially available sTfR assay," implying human serum/plasma samples. The type of samples (ranging from 0.41 to 3.5 mg/l) suggests clinical or laboratory-collected samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. For this type of in vitro diagnostic device, "ground truth" for the test set would typically be established by the results from the predicate device (Quantikine IVD human sTfR assay) or a reference method. The text does not mention any expert review of these results for the purpose of establishing ground truth for the comparison.

4. Adjudication Method for the Test Set

This information is not specified in the provided text. Adjudication methods (like 2+1, 3+1) are usually relevant when expert reviewers are determining a diagnosis or outcome from images or complex clinical data. For a quantitative assay comparison, the "ground truth" is typically the measurement from the reference method or predicate, and adjudication in the traditional sense is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging tool. Therefore, a study involving human readers and AI assistance for interpreting results is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The study directly assessed the performance of the N Latex sTfR Reagent itself (the "algorithm only") by comparing its measurements to those of a predicate device and evaluating its precision. This "standalone" assessment of the device's analytical performance is the core of the submission. The "human-in-the-loop" component for this type of device would involve laboratory technicians performing the test and clinicians interpreting the results, but the study itself focuses on the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth for the correlation study was established by the measurements obtained from the predicate device (or a "commercially available sTfR assay"). For precision studies, the ground truth refers to the expected value of the control materials and human serum pools used, which would have established ranges or target values based on prior validation.

8. The Sample Size for the Training Set

This information is not provided in the text. This type of device (a reagent for an immunoassay) typically does not involve a "training set" in the machine learning sense. The performance characteristics (correlation, precision) are determined through analytical validation studies, not by training an algorithm on a large dataset.

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

As there is no training set in the machine learning sense for this device, this question is not applicable. The device's formulation and operational parameters would be developed through R&D, and its performance validated through studies like those described, rather than "trained."

Summary

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K991157

Dade Behring Inc. N Latex STR Readant 510(k) Notification

1000

510(k) Summary For N Latex sTfR Reagent

Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:

Contact Information:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Carolyn K. George Tel: 302-631-6283

Preparation date:

April 5, 1999

Device Name/ Classification: 2.

N Latex sTfR Reagent:

Class II (866.5880)

Transferrin immunological test system

Classification Number:

Identification of the Legally Marketed Device: 3.

Quantikine IVD human sTfR assay

4. Device Description:

Device Intended Use: ર.

In vitro diagnostic reagent for quantitative determination of soluble transferrin receptor (sTfR) in human serum or heparinized plasma by particle enhanced nephelometry.

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

There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative measurement of sTfR in human serum or plasma. One such product is the Quantikine IVD human sTfR immunoassay (K970718). N Latex sTfR is substantially equivalent in intended use and results obtained to the Quantikine IVD human sTfR immunoassay. The N Latex sTfR, like the Quantikine IVD human sTfR immunoassay is intended to be used for the quantitative determination of sTfR in human serum or plasma.

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Device Performance Characteristics: 7.

Correlation:

N Latex sTfR Reagent was compared to a commercially available sTfR assay by evaluation of 62 samples ranging from 0.41 to 3.5 mg/l. A correlation coefficient of 0.96 was obtained, with a y-intercept value of -0.19 and a slope of 0.81.

Precision:

Precision studies were performed by the evaluation of three levels of control material and two levels of human serum pools in a manner consistent with NCCLS Guideline EP5-T2. The inter-assay precision ranged from 0.8 to 1.2%, while the intra-assay precision ranged from 1.4 to 2.1%.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles or faces arranged in a flowing, wave-like pattern.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 2 1999

Ms. Rebecca S. Ayash Manager, Regulatory, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

K991157 Re: Trade Name: N Latex sTfR Reagent Regulatory Class: II Product Code: DDG Dated: July 1, 1999 Received: July 2, 1999

Dear Ms. Ayash:

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 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 requirements, 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 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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Dade Behring Inc. N Latex sTfR Reagent 510(k) Notification

Indications Statement

N Latex sTfR Reagent Device Name:

Indications for Use:

Artha Moran

(Division Sign-Off) Division of Clinical Laboratory Devices 99 1157 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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).