Establishment of reference curves for the determination of IgG, IgG1-4, IgA, IgE, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α3-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain Iambda & kappa, soluble Transferrin Receptor (sTfR), Ferritin, ß2-microglobulin, and Total protein by immunonephelometry with BN™ Systems.

Device Description

N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with BN™ Systems (particle-enhanced nephelometry).

AI/ML Overview

This document describes various aspects of the N Protein Standard SL device. However, it does not contain information typically required to describe acceptance criteria and a study that proves a device meets them for a AI/ML-based medical device.

The provided text is a 510(k) summary for a calibrator, multi-analyte, which is a laboratory reagent used to establish reference curves for measuring human serum proteins. It is not an AI/ML-based device.

Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC) or address aspects like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These criteria are relevant for evaluating AI/ML models, not for a chemical calibrator.

The only "performance characteristic" mentioned is stability:

Device Performance Characteristics:

Stability: Stability was evaluated according to Dade Behring protocols and the standard was found stable as originally packaged and for at least 14 days at +2° to +8° C, once opened.

This describes a stability test, which is a common quality control measure for chemical reagents, but it doesn't involve the kind of rigorous clinical or radiological study described in your prompt for AI/ML devices. Therefore, a table of acceptance criteria and reported performance, as requested, cannot be generated from this document because the device type and the nature of its evaluation are fundamentally different.

Summary

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SEP 2 8 2001

510(k) Summary For N Protein Standard SL

K-012470

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: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

July 31, 2001

Device Name/ Classification: 2.

N Protein Standard SL:

Calibrator, Multi-Analyte

Classification Number:

Class II (862.1150)

Identification of the Legally Marketed Device: 3.

N Protein Standard SL (K002804)

Device Description: 4.

Device Intended Use: 5.

Establishment of reference curves for the determination of IgG, IgG, IgA, IgE, C3c, C4, Transferrin, Albumin, α--antitrypsin, α2-macroglobulin, Haptoglobin, α3-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, soluble Transferrin Receptor (sTfR), Ferritin, ßz-microglobulin, and Total protein by immunonephelometry with BN™ Systems.

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

The N Protein Standard SL (modified to include total protein) is substantially equivalent in intended use to the Dade Behring N Protein Standard SL (K002804) currently marketed. The modified N Protein Standard SL, like the current N Protein Standard SL is intended to be used for the calibration of human serum protein assays on BN™ Systems.

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Dade Behring Inc. N Protein Standard SL 510(k) Notification

Device Performance Characteristics: 7.

Stability:

Stability .
Stability was evaluated according to Dade Behring protocols and the standard was found Stablity was evaluated abooraing to Date Donning to Bas originally packaged and for at least 14 days at +2° to +8° C, once opened.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected by a flowing line.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 8 2001

Ms. Rebecca S. Ayash Director, Regulatory Affairs Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: K012470 Trade/Device Name: N Protein Standard SL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 31, 2001 Received: August 2, 2001

Dear Ms. Ayash:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 1 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, (1) sase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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 Protein Standard SL 510(k) Notification

Indications for Use Statement

N Protein Standard SL Device Name:

Indications for Use:

(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)

Kena Alexander Juan Cooper

ices 510(k) Number

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.