(43 days)
No
The summary describes a standard in vitro diagnostic reagent and its performance characteristics, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic reagent used to quantify IgE in human samples, aiding in diagnosis. It does not provide any treatment or therapy.
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." This indicates its role in the diagnostic process.
No
The device is described as an "In vitro diagnostic reagent" and a "Reagent," which are physical substances used in laboratory tests, not software. It is also intended to be used with "Behring Nephelometer Systems," which are hardware instruments.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "In vitro diagnostic reagent" and describes its use for the quantitative determination of IgE in human serum or plasma, which are biological samples taken from the body. It also mentions aiding in diagnosis.
- Device Description: Reinforces its use for the "quantitative determination of Immunoglobulin E (IgE) in human serum or plasma."
- Performance Studies: Describes studies performed on "human serum pools," further indicating the use of biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
In vitro diagnostic reagent for the quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
DGC
Device Description
N Latex IgE mono Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of Immunoglobulin E (IgE) in human serum or plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Correlation:
The N Latex IgE mono assay was compared to the N Latex IgE assay by evaluating 70 samples ranging from 14 to 855 IU/ml. A correlation coefficient of 1.0 was obtained, with a y-intercept value of 6.1 and a slope of 1.0.
Precision:
Precision studies were performed by the evaluation of three levels of control material and two levels of human serum pools in a manner consistent with NCCLS Guideline EP5-T2. The inter-assay precision ranged from 1.5 to 4.1%, while the intra-assay precision ranged from 1.7 to 3.0%.
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
JUL -7 1999
510(k) Summary For N Latex IgE mono Reagent
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: 1 99 | 787
- Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
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: Rebecca S. Ayash Tel: 302-631-6276
Preparation date:
May 24, 1999
2. Device Name/ Classification:
N Latex IgE mono Reagent:
immunological test system
Immunoglobulins A, G, M, D, and E
Classification Number:
Class II (866.5510)
3. ldentification of the Legally Marketed Device:
N Latex IgE kit (K890530)
Device Description: 4.
N Latex IgE mono Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of Immunoglobulin E (IgE) in human serum or plasma.
5. Device Intended Use:
In vitro diagnostic reagent for quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems.
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6. 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 of IgE in human serum or plasma. One such product is the Dade Behring N Latex IgE kit (K890530). N Latex IgE mono Reagent is substantially equivalent in intended use and results obtained to the N Latex IgE kit. The N Latex IgE mono Reagent, like the N Latex IgE kit is intended to be used for the quantitative determination of IgE in human serum or plasma using the Behring Nephelometer Systems.
7. Device Performance Characteristics:
Correlation:
The N Latex IgE mono assay was compared to the N Latex IgE assay by evaluating 70 samples ranging from 14 to 855 IU/ml. A correlation coefficient of 1.0 was obtained, with a y-intercept value of 6.1 and a slope of 1.0.
Precision:
Precision studies were performed by the evaluation of three levels of control material and two levels of human serum pools in a manner consistent with NCCLS Guideline EP5-T2. The inter-assay precision ranged from 1.5 to 4.1%, while the intra-assay precision ranged from 1.7 to 3.0%.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL -7 1999
Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology DADE BEHRING INC. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
Re: K991787
Trade Name: N Latex IgE mono Reagent Regulatory Class: II Product Code: DGC Dated: May 24, 1999 Received: May 25, 1999
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally, 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Dade Behring Inc. N Latex IgE mono Reagent 510(k) Notification
Indications Statement
Device Name:
N Latex IgE mono Reagent
Indications for Use:
In vitro diagnostic reagent for the quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991787 |
| Prescription Use (Per 21 CFR 801.109) | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|
| --------------------------------------- | ----------------------------------------------- |