(137 days)
Not Found
No
The summary describes a standard immunochemical reaction and light scattering measurement, with no mention of AI or ML terms or concepts.
No
Explanation: This device is an in vitro diagnostic reagent used to measure immunoglobulins, which aids in diagnosis. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents by determining the quantitative concentrations of immunoglobulins.
No
The device description clearly states it involves "in vitro diagnostic reagents" and "immunochemical reaction with specific antibodies," which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "In vitro diagnostic reagents for the quantitative determination of immunoglobulins..." and that these measurements "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates the device is intended for use outside the body to diagnose or aid in the diagnosis of a medical condition.
- Device Description: The description details a method for analyzing components of human body fluids (serum, plasma, CSF) using immunochemical reactions and light scattering. This is a typical method used in in vitro diagnostics.
- Predicate Device: The mention of a predicate device with a K number (K860894) and the name "N Antisera to Human Immunoglobulins (IgG, IgA and IgM)" further confirms that this device is being compared to a previously cleared IVD.
All these factors strongly indicate that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes (comma separated list FDA assigned to the subject device)
CFN
Device Description
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
510(k) Summary for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathieen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
September 30, 2004
-
- Device Namel Classification: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay Class: Immunological Test System, Class II, 21 CFR 866.5510 Panel: Immunology Product Code: CFN
3. Identification of the Legally Marketed Device:
N Antisera to Human Immunoglobulins (IgG, IgA and IgM) - K860894
Device Description: 4.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
1
5. Device Intended Use:
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, lgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems.
6. Medical device to which equivalence is claimed and comparison information:
The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay is substantially equivalent to the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) currently marketed (K860894). The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay, like the current N Antisera to Human Immunoglobulins (IgG, lgA, and IgM) assay, is intended for the quantitative determination of immunoglobulins (IgG, IgA and IgM) by means of immunonephelometry on the BN™ Systems.
7. Device Performance Characteristics:
| 11 3 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -
16 2012 2018 11:20 | Sprunt vorsusel
11 - 3 - 3 - 3 - 3 - 3 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | BECK BEACH | and the country of the country of the consideration of the successful and the subsequence of the subsequence of the subsequence of the sub- | a mailied and a more and the maint of the maile one | and accompany in |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------|
| lgG | Heparinized | 49 | 0.969 | 0.155 | 0.993 |
| | EDTA | 20 | 0.978 | -0.102 | 0.993 |
| laA | Heparinized | 49 | 1.003 | -0.031 | 0.998 |
| | EDTA | 20 | 0.947 | 0.014 | 0.998 |
| laM | Heparinized | 49 | 0.988 | 0.001 | 0.994 |
| | EDTA | 20 | 0.920 | 0.024 | 0.994 |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right and has a stylized design.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 5 2005
Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Regulatory Affairs and Compliance Manager P.O. Box 6101 Newark, DE 19714
Re: K042735
k042 133
Trade/Device Name: N Antisera to Human Immunoglobulins (IgG, IgA and IgM) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Systems Regulatory Class: Class II Product Code: CFN Dated: September 30, 2004 Received: October 1, 2004
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your boother to the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround to regard date of the Medical Device Amendments, or to devices that prior to May 26, 1770, the onadances with the provisions of the Federal Food, Drug, and Cosmetic have been recuire and acceraroval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, matice the detrice, day of the manual registration, listing of devices, good controls provisions or allabeling, 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 sam adazine , 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 r reast of advisou that I be remination that your device complies with other requirements of the Act or that FDA mas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, morading, sectice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
comfor provisions (Sections 551 - 12 tresteting your device as described in your Section 510(k) I ins icter will anow you to objin maintaing of substantial equivalence of your device to legally
3
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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 If you desire specific advice for your ac not to rease note the regulation entitled, comaci the Office of Comphance at (210) at Cetion" (21CFR Part 807.97). You may obtain other MISolanding of reference to promaibilities under the Act from the Division of Small general international on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501)445-0597 of at its intornet audioss
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert Beckh.
Robert L. Becker, Jr., M.D., PhØ Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Antisera to Human Immunoglobulins (IgG, IgA and IgM) Assay 510(k) Notification - Modification
Indications Statement
Device Name:
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay
Indications for Use:
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use
(Per 21 CFR 801 Subpart D)
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 Olan
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042753
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