(69 days)
Not Found
No
The device description details a standard immunonephelometry method based on light scattering and comparison to known standards, with no mention of AI or ML techniques.
No.
This device is an in vitro diagnostic reagent used to determine IgA levels, which aids in evaluating the patient's immune system, not in treating or directly affecting a patient's health condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "in vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples," indicating its use in diagnosing or aiding in the evaluation of a patient's immune system.
No
The device description clearly states it involves physical components (polystyrene latex particles, antibodies) and relies on a specific hardware system (BN™ Systems) for measurement. It is an in vitro diagnostic reagent kit, not a software-only device.
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 IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples". This clearly indicates the device is intended for use outside of the body to diagnose or aid in the diagnosis of a condition.
- Device Description: The description details a laboratory test method (particle-enhanced immunonephelometry) that analyzes biological samples (CSF and serum) to measure a specific analyte (IgA). This is characteristic of an in vitro diagnostic device.
- Anatomical Site: The samples analyzed are from the human body (CSF and serum), which are collected and tested in vitro.
The information provided strongly aligns 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 IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA aids in the evaluation of the patient's immune system.
Product codes
81 CZP
Device Description
Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of 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
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Summary of Performance Studies
Correlation:
Assay: N Latex IgA, Sample Type: CSF, n= 50, Slope: 1.008, Intercept: -0.324, Correlation Coefficient: 0.991
Assay: N Latex IgA, Sample Type: Serum, n= 50, Slope: 1.123, Intercept: -0.067, Correlation Coefficient: 0.992
Assay: N Latex IgA, Sample Type: Serum/CSF Ratio, n= 50, Slope: 0.910, Intercept: -0.146, Correlation Coefficient: 0.988
Key Metrics
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
FEB 1 3 2003
510(k) Summary for N Latex IgA
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: _ K 0 2 4 0 3 8
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
Marburg/Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lvons Tel: 781.826.4551
Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Preparation date:
December 4, 2002
Device Name/ Classification: 2.
| N Latex IgA: | Immunoglobulin A, G, M, D and E immunological test |
|---|---|
| system, Class II (866.5510) | |
| Product Code: | 81 CZP |
Identification of the Legally Marketed Device: 3.
Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549)
4. Device Description:
Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.
1
5. Device Intended Use:
In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN" Systems. The determination of IgA aids in the evaluation of the patient's immune system.
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- Medical device to which equivalence is claimed and comparison information: There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination IgA in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System IGALC assay (K993549). The N Latex igA is substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay. The N Latex IgA, like IMMAGE® IGALC assay is intended to be used for the quantitative determination of IgA in human serum or CSF.
7. Device Performance Characteristics:
| Assay | Sample Type | (n=) | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|---|
| N Latex IgA | CSF | 50 | 1.008 | -0.324 | 0.991 |
| Serum | 50 | 1.123 | -0.067 | 0.992 | |
| Serum/CSF Ratio | 50 | 0.910 | -0.146 | 0.988 |
Correlation:
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
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 three human profiles facing right, stacked on top of each other. The profiles are enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714
FEB 1 3 2003
Re: K024038
Trade/Device Name: N Latex IgA Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CZP Dated: January 29, 2003 Received: January 31, 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 (OS) 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.
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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
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K024038 Indications Statement
Device Name: N Latex IgA
Indications for Use:
In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA 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)
| (Division Sign-Off) | J PReeves for J. Bautista |
|---|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number | K024038 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | Over-The-Counter-Use
(Optional Format 1-2-96) |
| ------------------------------------------ | -------------------------------------------------- |
|---|
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