(150 days)
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No
The summary describes a standard in vitro diagnostic test system using a flow cytometer and specific reagents to measure IgE concentration based on fluorescent signal. There is no mention of AI or ML in the device description, intended use, or performance studies. The software mentioned is likely for controlling the flow cytometer and processing the raw fluorescent data into a concentration value, which is a typical function of such systems and does not inherently imply AI/ML.
No.
Explanation: The device is an in vitro diagnostic test system used to measure total IgE in human serum, which aids in the diagnosis of IgE mediated allergic disorders. It does not treat or cure any condition, but rather provides diagnostic information.
Yes
The text explicitly states in the Intended Use / Indications for Use section that "The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system". It also mentions it is used as an "aid in the clinical diagnosis of IgE mediated allergic disorders", which directly aligns with the purpose of a diagnostic device.
No
The device description explicitly states that the system consists of two components: a flow cytometer instrument with software and reagents. This indicates the presence of hardware (flow cytometer) and chemical components (reagents) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system..." and "The ImmuneTech™ Total IgE System is intended for clinical laboratory use." It also describes its use as an "aid in the clinical diagnosis of IgE mediated allergic disorders," which is a diagnostic purpose.
- Device Description: The description details how the system measures total IgE in human serum using reagents and a flow cytometer. This process involves analyzing a biological sample (serum) outside of the body to provide information about a person's health status, which is the definition of an in vitro diagnostic.
- Clinical Laboratory Use: The intended user is specified as "clinical laboratory use," which is a common setting for IVD devices.
- Performance Studies: The document includes a summary of performance studies (method comparison, sensitivity, specificity, accuracy, precision), which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device(s): The mention of predicate devices (K020387 MyAllergyTest™ System; K991945 Pharmacia CAP System IgE FEIA) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All of these points strongly indicate that the ImmuneTech™ Total IgE System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex 100TM Integrated System.
The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system used as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Product codes (comma separated list FDA assigned to the subject device)
82 DHB, DGC
Device Description
ImmuneTech™ Total IgE System is a test for the measurement of total IgE in human serum. The ImmuneTech™ Total IgE System consists of two components.
-
- Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
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- ImmuneTech™ Total IgE System Reagents
A serum sample is mixed with anti-IgE coupled microspheres. If present, IgE in the sample will bind with the microspheres and form an anti-human IgE / IgE complex. This complex is then sequentially incubated with biotin-labeled-anti-human IgE antibody and fluorescent-labeled-streptavidin. If IgE is present in the sample, the final sandwich complex of anti-human IgE / IgE / biotin-anti IgE / fluorescent-streptavidin will form. Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of total IgE in the sample. The flow cytometer with ImmuneTech ™ Total IgE System specific software will measure total IgE concentrations.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to evaluate the performance (method comparison, sensitivity, specificity, accuracy (recovery) and precision of the ImmuneTech™ Total IgE System.
| Study | Result |
|---|---|
| Method Comparison | Correlation Coefficient 0.97; y=1.00x+6.03 |
| Sensitivity | 2 IU/mL |
| Specificity | Non cross reactive to IgG, IgA or IgM |
| Recovery | 99.8% |
| Between Day Precision | CV 3-10% |
| Within Day Precision | CV 2-9% |
Expected results study indicate 76% of non-atopic individuals with total IgE levels 100 IU/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 2 IU/mL
Specificity: Non cross reactive to IgG, IgA or IgM
Recovery: 99.8%
Between Day Precision: CV 3-10%
Within Day Precision: CV 2-9%
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.
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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).
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§ 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
10. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of The Safety Medical Device Act of 1990 and 21 CFR Part 807.92 K032251 510(k) Number
| Date of Summary Preparation: | July 10, 2003 |
|---|---|
| Submitter: | ImmuneTech Corporation |
| Contact Person: Vivianne Noetzel | |
| Address: P.O. Box 9433 | |
| 17394 Via Del Bravo | |
| Rancho Santa Fe, CA 92067 | |
| Phone: 858-756-8483 | |
| FAX: 858-759-7492 | |
| Manufacturing Site: | ImmuneTech Corporation |
| Address: 888 Oak Grove Ave., Suite 4 | |
| Menlo Park, CA 94025 | |
| Phone: 650-470-7420 | |
| FAX: 650-470-7423 | |
| Device Trade Name: | ImmuneTech™ Total IgE System |
| Device Common Name: | Total IgE Test System for the measurement of total IgE. |
| Device Classification: | Class II (21 CFR 866.5750) |
| Device Product Code: | 82 DHB |
| Performance Standards: | None established (as a medical device) under Section 514 |
Device Description: ImmuneTech™ Total IgE System is a test for the measurement of total IgE in human serum. The ImmuneTech™ Total IgE System consists of two components.
-
- Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
-
- ImmuneTech™ Total IgE System Reagents
A serum sample is mixed with anti-IgE coupled microspheres. If present, IgE in the sample will bind with the microspheres and form an anti-human IgE / IgE complex. This complex is then sequentially incubated with biotin-labeled-anti-human IgE antibody and fluorescent-labeled-streptavidin. If IgE is present in the sample, the final sandwich complex of anti-human IgE / IgE / biotin-anti IgE / fluorescent-streptavidin will form. Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of total IgE in the sample. The flow cytometer with ImmuneTech ™ Total IgE System specific software will measure total IgE concentrations.
Intended Use: The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex (00TM Integrated System.
Indications for Use: The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system used as an aid in the clinical diagnosis of IgE mediated allergic disorders.
1
Substantial Equivalence Claim to:
| MyAllergyTest™ System | K020387 | 4/17/2002 |
|---|---|---|
| Pharmacia CAP System IgE FEIA | K991945 | 7/28/1999 |
Brief Description of Performance Data:
Studies were performed to evaluate the performance (method comparison, sensitivity, specificity, accuracy (recovery) and precision of the ImmuneTech™ Total IgE System.
| Study | Result |
|---|---|
| Method Comparison | Correlation Coefficient 0.97; y=1.00x+6.03 |
| Sensitivity | 2 IU/mL |
| Specificity | Non cross reactive to IgG, IgA or IgM |
| Recovery | 99.8% |
| Between Day Precision | CV 3-10% |
| Within Day Precision | CV 2-9% |
Expected results study indicate 76% of non-atopic individuals with total IgE levels 100 IU/mL.
Conclusion: These studies demonstrate the substantial equivalence of the ImmuneTech™ Total IgE System to a currently marketed device that has been reviewed and cleared through the 510(k) notification process. They further demonstrate the suitability for use of the product for clinical laboratory professional use.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three wavy lines extending from the figure's head. The figure and lines are black, and the background is white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2003
Ms. Vivianne Noetzel ImmuneTech Corporation P.O. Box 9433 17394 Via Del Bravo Rancho Santa Fe, CA 92067
Re: K032251
Trade/Device Name: ImmuneTech™ Total IgE System Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobins A, G, M, D, and E Immunological Test System Regulatory Class: Class II Product Code: DGC Dated: November 21, 2003 Received: December 2, 2003
Dear Ms. Noetzel:
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, 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 (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).
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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.
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). Other general information on your responsibilities under the Act may be obtained 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.
Sincercly yours,
Steven Putman
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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INDICATIONS FOR USE STATEMENT
K032251 510(k) Number:
ImmuneTech™ Total IgE System Device Name:
Indications for Use:
The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex 100TM Integrated System.
Maria Chen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032257
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________