(48 days)
No
The summary describes a standard immunochemical reaction and analysis method (immunonephelometry) without mentioning any AI or ML components. The performance studies focus on method comparison and correlation, not AI/ML model validation.
No
The device is described as an in vitro diagnostic reagent used to determine complement factors in human samples for diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is for "quantitative determination of complement factors (C3/C3c and C4/C4c) ... as an aid in the diagnosis of immunologic disorders." This explicitly indicates its role in diagnosis.
No
The device is described as in vitro diagnostic reagents and antibodies, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for "In vitro diagnostic reagents". It also describes the purpose of the device as aiding in the diagnosis of immunologic disorders by measuring complement factors in human serum or plasma. This clearly indicates it's used to test samples taken from the body in vitro (outside the body) for diagnostic purposes.
- Device Description: The description mentions the use of "human body fluids" and "immunochemical reaction," further supporting its use with biological samples outside the body.
- Performance Studies: The "Summary of Performance Studies" describes testing performed on "serum and heparinized or EDTA plasma," which are biological samples.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
CZW, DBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
correlation coefficients between 0.98 and 0.99.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 GmbH
Emil-von-Behring Str. 76
Marburg/Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
Glasgow Site
P.O. Box 6101
Newark, Delaware 19714
Attn: Donna Wolf
Tel: 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.
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.
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:
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.
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