In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.

Device Description

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.

AI/ML Overview

Acceptance Criteria and Study for N Antisera to Human Complement Factors (C3c, C4)

This submission describes the acceptance criteria and the study that proves the device meets those criteria for the N Antisera to Human Complement Factors (C3c, C4). The primary focus of this submission is to demonstrate equivalence in performance when expanding the intended use to include heparinized or EDTA plasma as specimen types, in addition to serum.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Serum to Plasma Equivalence	Correlation coefficient between serum and heparinized plasma measurements ≥ 0.95	0.98 - 0.99	This range meets the acceptance criteria, demonstrating strong correlation.
Serum to Plasma Equivalence	Correlation coefficient between serum and EDTA plasma measurements ≥ 0.95	0.98 - 0.99	This range meets the acceptance criteria, demonstrating strong correlation.

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

The exact sample size for the test set (number of patient samples) is not explicitly stated in the provided document. The study performed "method comparisons" to demonstrate equivalence.

The data provenance (country of origin, retrospective or prospective) is not explicitly stated. However, given it's a 510(k) submission for a device marketed by Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), it's likely a controlled, prospective validation study conducted in a laboratory setting, potentially using samples from a relevant patient population.

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

This information is not applicable to this type of device and study. The ground truth for this device is not established by expert clinical review of images or diagnoses. Instead, the accuracy of the device is assessed by its ability to quantitatively determine complement factors, where established laboratory methods serve as the reference for comparison.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical data (e.g., imaging studies) where multiple experts resolve discrepancies. For quantitative assays like this, agreement is assessed statistically.

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

An MRMC comparative effectiveness study was not performed and is not relevant for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. This submission focuses on the analytical performance of a quantitative assay.

6. Standalone (Algorithm Only) Performance Study

This is an in vitro diagnostic assay, not an algorithm or AI system in the traditional sense. The "device" itself is the reagent. Therefore, a "standalone algorithm performance" study is not applicable. The performance is intrinsically linked to the assay's ability to accurately measure the target analytes. The study explicitly focuses on the analytical performance of the assay and its reagents in different sample matrices.

7. Type of Ground Truth Used

The ground truth for the test set was established by comparison to serum measurements using the current, legally marketed N Antisera to Human Complement Factors (C3c and C4) assays.

The study essentially compares the quantitative results obtained from heparinized or EDTA plasma samples with the quantitative results obtained from serum samples (which represent the established "ground truth" or reference for this assay type). The correlation coefficients of 0.98-0.99 indicate that the measurements in plasma are highly consistent with those in serum.

8. Sample Size for the Training Set

This information is not applicable. This device is a reagent for a quantitative diagnostic assay. It does not employ machine learning or AI models that require a "training set" in the conventional sense. The "learning" or optimization of the assay's performance would occur during its initial development and validation stages through extensive analytical testing, not through a "training set" like an AI algorithm.

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

This information is not applicable as there is no "training set" for this type of in vitro diagnostic device, as explained in point 8.

Summary

{0}------------------------------------------------

l050665

Dade Behring Inc. N Antisera to Human Complement Factors (C3c, C4) 510(k) Notification

510(k) Summary N Antisera to Human Complement Factors (C3c, C4)

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

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 76Marburg/Germany
Contact Information:	Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Donna WolfTel: 302-631-0384
Preparation date:	March 14, 2005

Device Name/ Classification: 2.

N Antisera to Human Complement Factors (C3c and C4) / Complement components C3, C4 immunological test system, Class II (866.5240)

Identification of the Legally Marketed Device: 3.

N Antisera to Human Complement Factors (C3c and C4), K860894

Device Description: 4.

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.

Device Intended Use: 5.

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

The N Antisera to Human Complement Factors (C3c and C4) assay (modified) is substantially equivalent in intended use, principle and performance to the current N Antisera to Human Complement Factors (C3c and C4) assays. The modified assays, like the current assays are intended for use in the quantitative determination of complement factors (C3c and C4) in human serum. The modified assays differ from the currently marketed product in that the intended use has been expanded to include heparinized or EDTA plasma as specimen types.

Device Performance Characteristics: 7.

Serum to Plasma Comparison:

To demonstrate equivalence in measurement between serum and heparinized or EDTA plasma, method comparisons were performed. The studies demonstrate equivalent performance with correlation coefficients between 0.98 and 0.99.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the symbol.

Public Health Service

MAY - 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c/o Ms. Donna A. Wolf Regulatory Affairs and Compliance Manager 500 GBC Dr., MailStop 514 P.O. Box 6101 Newark, DE 19714

Re: K050665

K050005
Trade/Device Name: N Antisera to Human Complement Factors (C3c, C4) Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW, DBI Dated: March 14, 2005 Received: March 15, 2005

Dear Ms. Wolf:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your bootion by of be device is substantially equivalent (for the indications for reletect above and nave acteminated are devices marketed in interstate commerce use stated in the encrosure) to regally inal of the Medical Device Amendments, or to devices that provision way 20, 1770, the onecance 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, ACt (Act) that do flot require applect to the general controls provisions of the Act. The general therefore, mance the de rios, bacreer we are annual registration, listing of devices, good Controls provisions or alabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice to such additional controls. Existing major regulations affecting your device can be may be subject to ston ademisions, 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 F Icase be advised mar 1 271 5 issuality it your device complies with other requirements of the Act or that FDA has made a decemination administered by other Federal agencies. You must comply with all 1 coclai statures and regulations and limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, morading, vactice requirements as set forth in the quality iablems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 335cmb (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Ms. Donna A. Wolf

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 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), please contact the Office of Compliance at (240) 276-0131. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Robert H. Becker/

Robert L. Becker, Jr., M.D., PAD Director Division of Immunology and Hematology Devices

Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Dade Behring Inc. Dade Denning the:
N Antisera to Human Complement Factors (C3c, C4) 510(k) Notification

Indications for Use Statement

Device Name:

N Antiserum to Human Complement Factors (C3c and C4)

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use -----------------------------------------------------------------------------(21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Maria M Chan
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050665

Regulation Number and Section

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).