(38 days)
Not Found
No
The description details a standard immunonephelometry assay based on light scattering and comparison to a known standard, with no mention of AI or ML terms or concepts.
No.
The device is an in vitro diagnostic test used for quantitative determination of IgM in human samples, aiding in the evaluation of the patient's immune system, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is explicitly stated as "an in vitro diagnostic test for the quantitative determination of IgM". This indicates its purpose is to aid in the evaluation of a patient's immune system, which is a diagnostic function.
No
The device description clearly indicates it is a physical in vitro diagnostic test using polystyrene latex particles and a light scattering method, which are hardware components.
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 an "in vitro diagnostic test."
- Sample Type: The test is performed on human cerebrospinal fluid (CSF) and serum, which are biological samples taken from the body.
- Purpose: The test is used for the "quantitative determination of IgM" and "aids in the evaluation of the patient's immune system," which are diagnostic purposes.
- Method: The "Device Description" describes a laboratory method (particle-enhanced immunonephelometry) used to analyze the samples.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
N Latex IgM is an in vitro diagnostic test for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.
Product codes
81CFN, CFN
Device Description
Polystyrene latex particles coated with antibodies specific to human IgM are agglutinated when mixed with samples containing human IgM. These aggregates 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
human cerebrospinal fluid (CSF) and in paired CSF/serum samples
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)
Correlation:
Assay: N Latex IgM, Sample Type: CSF, n=: 24, Slope: 1.04, Intercept: -0.02, Correlation Coefficient: 0.995
Assay: N Latex IgM, Sample Type: Serum, n=: 50, Slope: 0.91, Intercept: +0.02, Correlation Coefficient: 0.979
Assay: N Latex IgM, Sample Type: CSF/Serum Ratio, n=: 24, Slope: 1.03, Intercept: -0.01, Correlation Coefficient: 0.989
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ade Behring Inc 510(k) Notification
AUG - 7 2003
510(k) Summary for N Latex 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 Preparation:
Manufacturer:
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
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: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
June 26, 2003
-
- Device Name/ Classification:
| N Latex IgM: | Immunologlobulin A, G, D and E immunological test |
|---|---|
| system, Class II (866.5510) | |
| Product Code: | 81CFN |
-
- Identification of the Legally Marketed Device: Beckman Coulter IMMAGE® Immunochemistry System Low Concentration immunoglobulin M (IGMLC) assay (K993547)
4. Device Description:
Polystyrene latex particles coated with antibodies specific to human IgM are agglutinated when mixed with samples containing human IgM. These aggregates 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
Dade Behring Inc. N Latex IgM 510(k) Notification
5. Device Intended Use:
In vitro diagnostic reagents for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.
- Medical device to which equivalence is claimed and comparison information: 6. There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination of IgM in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Assay (K993547). The N Latex IgM is substantially equivalent in intended use and results obtained to the IMMAGE® IGMLC assay.
7. Device Performance Characteristics:
Correlation:
| Assay | Sample
Type | (n=) | Slope | Intercept | Correlation
Coefficient |
|-------------|-----------------|------|-------|-----------|----------------------------|
| N Latex IgM | CSF | 24 | 1.04 | -0.02 | 0.995 |
| N Latex IgM | Serum | 50 | 0.91 | +0.02 | 0.979 |
| N Latex IgM | CSF/Serum Ratio | 24 | 1.03 | -0.01 | 0.989 |
Method Comparison Studies
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Re:
AUG - 7 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Manager. Regulatory Affairs and Compliance Dade Behring. Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
K032014 Trade/Device Name: N Latex IgM Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CFN Dated: June 26, 2003 Received: June 30, 2003
Dear Ms. Dray-Lyons:
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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
Page 2 –
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Dade Behring Inc. N Latex IqM 510(k) Notification
Indications Statement
【,】
Device Name: N Latex IgM
Indications for Use:
N Latex IgM is an in vitro diagnostic test for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.
(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) |
J.P. Reeves for S. Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety510(k).