Establishment of reference curves for the determination of IgG, IgG14, IgM, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer 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 the Behring Nephelometer Systems (particle-enhanced nephelometry).

AI/ML Overview

The provided 510(k) summary for the Dade Behring N Protein Standard SL primarily focuses on establishing substantial equivalence to a predicate device and discussing device stability. It does not contain the kind of detailed clinical study information (acceptance criteria, sample sizes for test/training, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth details) typically found in submissions for diagnostic devices with complex performance claims involving human interpretation or nuanced clinical outcomes.

This document describes a calibrator (a reference material used to ensure the accuracy of a diagnostic test), not a diagnostic device that directly produces an output for patient care. Therefore, the questions related to clinical performance metrics (like sensitivity, specificity, reader performance) and the setup of clinical studies (expert ground truth, adjudication, MRMC) are not applicable in the usual sense for this type of device.

However, I can extract the relevant information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Stable for specified duration at recommended storage conditions.	Stability: Stable for at least 12 months at +2° to +8° C (unopened). Stable for at least 14 days at +2° to +8° C (once opened).
Substantially equivalent to predicate device for intended use.	Device is substantially equivalent to N Protein Standard SL (K964062) for the calibration of human serum protein assays on Behring Nephelometer Systems, with the addition of sTfR.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical performance evaluation. The stability evaluation would typically involve multiple batches of the calibrator, tested at various time points, but the specific sample sizes for these tests are not provided.
Data Provenance: Not explicitly stated, but "in-house protocols" suggests internal testing by the manufacturer. No country of origin for specific stability data is mentioned, but the manufacturer is based in Germany and the submission is to the FDA in the USA. The type of study (retrospective/prospective) for stability is not detailed, but it would have been prospective over the stated shelf-life.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a calibrator, not a diagnostic tool requiring expert interpretation or ground truth establishment based on clinical cases. The "truth" for a calibrator lies in its certified concentration values and stability characteristics, which are determined by analytical methods and quality control procedures, not human experts in a clinical setting.

4. Adjudication method for the test set

Not applicable for the reasons stated in point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting clinical cases.

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

Not applicable. This is a biochemical calibrator, not an algorithm. Its performance is determined by its physical and chemical properties and its ability to accurately calibrate the intended assays.

7. The type of ground truth used

For stability, the "ground truth" would be the known concentration of the analytes within the calibrator as determined by validated reference methods or master calibrators, and the acceptable limits of variation from these known concentrations over time. The document states it was evaluated according to "in-house protocols," implying internal reference standards and analytical methods were used.

8. The sample size for the training set

Not applicable. This is not a machine learning device, so there is no "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable (see point 8).

In summary, this 510(k) submission is for a medical device calibrator. The performance evaluation focuses on the chemical and physical stability of the calibrator itself and its substantial equivalence to a previously marketed calibrator for its intended use in calibrating existing diagnostic assays. It does not involve complex clinical studies with human participants, expert ground truth, or AI algorithms.

Summary

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99/18/

JUN 1 1999

510(k) Summary For N Protein Standard SL

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

Class II (862.1150)

Device Name/ Classification: 2.

Calibrator N Protein Standard SL:

Classification Number:

3. ldentification of the Legally Marketed Device:

N Protein Standard SL (K964062)

Device Description: 4.

Device Intended Use: 5.

Establishment of reference curves for the determination of IgG, IgG+4, IgM, C3c, C4, Transferrin, Albumin, α-antitrypsin, α-macroglobulin, Haptoglobin, α-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.

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

The N Protein Standard SL (modified to include sTfR) is substantially equivalent in intended use to the N Protein Standard SL (K964062) currently marketed. The N Protein Standard SL (modified), like the current N Protein Standard SL is intended to be used for the calibration of human serum protein assays on the Behring Nephelometer Systems.

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

Device Performance Characteristics: 7.

Stability:

Stability was evaluated according to in-house protocols and the standard was found to be Stable for at least 12 months at +2° to +8° C, as 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

" (ਰਿਰੋਰੇ JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn K. George Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K991181

Trade Name: N Protein Standard SL: Calibrator Regulatory Class: II Product Code: JIX Dated: April 5, 1999 Received: April 7, 1999

Dear Ms. George :

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 Protein Standard SL 510(k) Notification

Indications for Use Statement

K991181

Device Name:

N Protein Standard SL

Indications for Use:

Pete E. Maler

(Division Sion-Division of Clinical La 510(x) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

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

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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.