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.

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.

1. Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
1. 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.

AI/ML Overview

This summarizes the acceptance criteria and study details for the ImmuneTech™ Total IgE System, based on the provided 510(k) summary.

I. Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (ImmuneTech™ Total IgE System)
Method Comparison	High correlation to predicate	Correlation Coefficient 0.97; y=1.00x+6.03
Sensitivity	Low detection limit	2 IU/mL
Specificity	No cross-reactivity	Non cross reactive to IgG, IgA or IgM
Recovery	High recovery rate	99.8%
Between Day Precision (CV)	Low variability	3-10%
Within Day Precision (CV)	Low variability	2-9%

II. Study Details

Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific sample size for the test set.
- The data provenance is not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this in vitro diagnostic device is based on analytical performance metrics (e.g., comparison to a predicate device, known concentrations for sensitivity, specificity, and recovery).
Adjudication method for the test set:
- Not applicable. This is an in vitro diagnostic device assessing analytical performance, not a diagnostic imaging or clinical judgment study requiring expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an in vitro diagnostic system, not a device that involves human readers or AI assistance in interpretation in the context of an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, at least in part. The studies evaluating "Method Comparison, Sensitivity, Specificity, Accuracy (recovery) and Precision" describe the analytical performance of the ImmuneTech™ Total IgE System itself, independent of human interpretation. While the system operates on a flow cytometer, the reported performance metrics focus on the device's ability to measure IgE concentrations directly.
The type of ground truth used:
- The ground truth appears to be established through:
  - Comparison to a legally marketed predicate device: "MyAllergyTest™ System" and "Pharmacia CAP System IgE FEIA" were used as comparators for method comparison.
  - Known concentrations/samples: For sensitivity, specificity, recovery, and precision studies, it is implied that samples with known IgE concentrations or characteristics (e.g., non-atopic vs. atopic individuals, samples without cross-reacting substances) were used.
The sample size for the training set:
- Not specified. The document does not mention details about a training set, as this typically applies more to machine learning algorithms, which are not explicitly detailed here beyond the software component. The performance data focuses on analytical validation.
How the ground truth for the training set was established:
- Not applicable, as a training set and its ground truth establishment are not discussed in the provided summary.

Summary

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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 CorporationContact Person: Vivianne NoetzelAddress: P.O. Box 943317394 Via Del BravoRancho Santa Fe, CA 92067Phone: 858-756-8483FAX: 858-759-7492
Manufacturing Site:	ImmuneTech CorporationAddress: 888 Oak Grove Ave., Suite 4Menlo Park, CA 94025Phone: 650-470-7420FAX: 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.

1. Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
1. ImmuneTech™ Total IgE System Reagents

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.

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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 < 25IU/mL and 89% of atopic individuals with total IgE levels of >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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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:

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).