The MyAllergyTest® is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest® is intended for use with the MyAllergyTest® system. The MyAllergyTest® is intended for home use.

Device Description

MyAllergyTest ® is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The device modification is to revise the limitations statement to allow testing of the whole blood sample for up to 30 days following collection. Currently the limitations states 10 days. No changes to the kit components.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a modification to the MyAllergyTest® device. The modification is to extend the allowable time for a whole blood sample to be tested from 10 days to 30 days after collection.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported (Implied) Device Performance
Maintain "accurate assessment of allergen specific IgE" for 30 days.	"The results from these studies (Initial testing and validation results) confirmed that the sample would be stable during the indicated transport time [30 days]."

Note: The document does not explicitly state numerical acceptance criteria (e.g., specific percentage agreement or correlation thresholds). The acceptance criterion is implied by the need to ensure an "accurate assessment" of IgE levels after 30 days.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the stability studies (test set). It also doesn't indicate the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The study appears to be about sample stability for laboratory testing, not interpretation by human experts. The "ground truth" would likely be established by lab-based assay results, not expert consensus in the traditional sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study involves laboratory measurements for sample stability, not expert interpretation requiring adjudication.

5. 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

This is not applicable. The device is a sample collection kit, and the study focuses on the stability of the collected sample, not on human reader performance or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical sample collection kit, and the study evaluates the bio-chemical stability of the collected sample, not an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the stability studies would be the allergen specific IgE profile testing results obtained from the clinical laboratory at different time points (including 30 days) and compared against a baseline (e.g., immediate testing). The "accuracy" would be determined by comparing these results, likely through quantitative measures of IgE levels.

8. The sample size for the training set

This is not applicable. The study is a validation of sample stability, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this type of device modification study.

Summary of the Study:

The study described is a "Blood Sample Stability Study." Its purpose was to "obtain assurance that the whole blood sample would still provide an accurate assessment of allergen specific IgE for the entire transport time indicated in the labeling (30 days)." The study involved "Initial testing and validation results," which "confirmed that the sample would be stable during the indicated transport time." This implies a comparison of IgE levels from samples tested at baseline and after 30 days to ensure they remain consistent or within an acceptable variation range, thereby maintaining the accuracy of the overall allergen-specific IgE assessment. The specific methodologies and statistical analysis are not detailed in this document but are referred to in "Attachment (s) B and C."

Summary

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6/21/06	MyAllergyTest®	Page 2 of 5
	Special 510K Device Modification
510K Number:	K061979
Submitter:	ImmuneTech CorporationNancy Benson888 Oak Grove Ave.Suite 4Menlo Park, CA 94025nancylbenson@earthlink.net650-233-0653 (home)650-274-5884 (cell)	SEP 2 2 2006
Manufacturing Site:	ImmuneTech Corporation888 Oak Grove Ave.Suite 4Menlo Park, CA 94025650-470-7420650-470-7423 (FAX)

Device Product Code: JKA

Description of the modified device:

Intended Use:

The MyAllergyTest ® is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The The MyAllergyTest ® is intended for use with the MyAllergyTest ® system (K020387). The MyAllergyTest ® is intended for home use by the lay consumer.

Proposed Labeling:

See attachment A

Summary of Device Testing:

Blood Sample Stability Studies were performed to obtain assurance that the whole blood sample would still provide an accurate assessment of allergen

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6/21/06	MyAllergyTest®	Page 3 of 5
	Special 510K Device Modification

specific IgE for the entire transport time indicated in the labeling (30 days). The results from these studies (Initial testing and validation results) confirmed that the sample would be stable during the indicated transport time. See attachment (s) B and C.

Summary of Design Control Activities:

Risk Analysis- see attachment C .
Validation PROD-0011 .
. Declaration of conformity
Project History file, not included in submission .

Attachments:

Proposed Labeling, Attachment A (4 pages) Initial Results, Attachment B (7 pages) Validation Results, Attachment C (8 pages) Risk Analysis, Attachment D (3 pages) Completed Corrective Action Letter to the 483, Attachment E (1 page)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the left and three stripes extending from its back. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 2 2006

ImmuneTech Corporation c/o Ms. Nancy Benson VP Quality Systems 888 Oak Grove, Suite 4 Menlo Park, CA 94025

Re: K061979

Trade/Device Name: My Allergy Test® Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: June 21, 2006 Received: July 13, 2006

Dear Ms. Nancy Benson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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 + Manniacturers; International Consumer Assistance at its toll-free-number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert G. Beckerf

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MyAllergyTest®

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of CDRH, Diagnostic Devices (OIVD)

Office of In Vitro Diag Device Evaluation and S

510(k) K5 61979

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.