(120 days)
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 by the lay consumer (Over-the-Counter).
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 provided text describes the MyAllergyTest™ and its 510(k) submission, primarily focusing on its intended use as a blood sample collection kit for home use. The studies performed are to demonstrate the kit's functionality and consumer usability, not the diagnostic performance of an AI algorithm. Therefore, many of the requested fields related to AI performance metrics, ground truth, and expert evaluation are not applicable to this device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Stability Studies | 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 (seven days). | "The results from these studies confirmed that the samples would be stable for the entire seven days." |
| Mailing Studies | Assurance that the whole blood samples would still provide an accurate assessment of allergen specific IgE if sent by US Mail. | "The results from these studies confirmed that the samples would be stable when shipped using US Mail." |
| Consumer Studies | Assurance that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert. | "The results from these studies confirmed that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert." |
| Consumer Comprehension Studies | Assurance that the general public would be able to read and understand the MyAllergyTest™ package insert. | "The results from these studies confirmed that the general public would be able to read and understand the MyAllergyTest™ package insert." |
| Readability Studies | Assurance that the MyAllergyTest™ package was written at a 7th grade reading level (based on NCCLS GP 14-A Labeling of Home-Use In Vitro Testing Products). The text specifies "70 grade reading level" but then reports "7th grade reading level" in the results, suggesting a minor typo in the criterion description or a direct application of the SMOG formula to determine the grade level. | "The results from the SMOG Readability Formula (NCCLS GP 14-A Labeling of Home-Use In Vitro Testing Products) confirmed that the MyAllergyTest™ package was written at a 7th grade reading level." (This meets the implicit 7th-grade criterion as intended by the 70 grade mention). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not specify the sample sizes used for any of the studies (Stability, Mailing, Consumer, Consumer Comprehension, Readability). It also does not mention the country of origin of the data or whether the studies were 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 is not applicable as the device is a sample collection kit, not an AI diagnostic tool. The "ground truth" for the studies listed is related to the physical stability of blood samples, the ability of lay users to follow instructions, and the readability of documentation, not expert interpretation of medical images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for reconciling discrepancies in expert ground truth assessment, which is not part of the described studies for this device.
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
Not applicable. The MyAllergyTest™ is a sample collection kit, not an AI system or software with a human-in-the-loop component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The MyAllergyTest™ is a physical medical device (sample collection kit), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these studies would be defined by objective measurements based on the study type:
- Stability Studies & Mailing Studies: The "ground truth" would be the actual concentration or integrity of allergen-specific IgE markers in the blood samples after various transport conditions and durations, as measured by a clinical laboratory.
- Consumer Studies: The "ground truth" would be the successful collection of a blood sample by the lay consumer, verified objectively (e.g., by the presence of a viable sample).
- Consumer Comprehension Studies: The "ground truth" would be the ability of lay consumers to correctly answer questions or demonstrate understanding of the package insert.
- Readability Studies: The "ground truth" would be the calculated reading level of the package insert using the SMOG Readability Formula.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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| 5/14//2002 |
|---|
| MyAllergy Test™ |
| 510(k) Premarket Submission |
| Page 11 |
7. 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
| 510(k) Number: | K021698 |
|---|---|
| SEP 1 9 2002 | |
| Date of Summary Preparation: | May 14, 2002 |
| 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, Suite 4 |
| Menlo Park, CA 94025 | |
| Phone: | 650-470-7420 |
| FAX: | 650-470-7423 |
| Device Trade Name: | MyAllergyTest™ |
| Device Common Name: | Blood Sample Collection Kit |
| Device Classification: | Class II (21 CFR 862.1675) |
| Device Product Code: | JKA |
| Performance Standards: | None established (as a medical device) under Section 514. |
| 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. | |
| 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 MyAllergyTest™ | |
| is intended for use with the MyAllergyTest™ System | |
| (K020387). The MyAllergyTest™ is intended for home use | |
| by the lay consumer. | |
| Indication for 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 MyAllergyTest™ | |
| is intended for use with the MyAllergyTest™ System. The |
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MyAllergyTest™ is intended for home use by the lay conusmer.
Substantial Equivalence Claim to:
Appraise-Cardio Sample Collection Kit K993787.
Summary of Device Testing:
Stability Studies were performed 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 (seven days). The results from these studies confirmed that the samples would be stable for the entire seven days.
Mailing Studies were performed to obtain assurance that the whole blood samples would still provide an accurate assessment of allergen specific IgE if sent by US Mail. The results from these studies confirmed that the samples would be stable when shipped using US Mail.
Consumer Studies were performed to obtain assurance that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert. The results from these studies confirmed that the general public would be able to obtain a blood sample by following the MyAllergyTest™ package insert.
Consumer Comprehension Studies were performed to obtain assurance that the general public would be able to read and understand the MyAllergyTest™ package insert. The results from these studies confirmed that the general public would be able to read and understand the MyAllergyTest™ package insert.
Readability Studies were performed to assurance that the MyAllergyTest™ package was written at a 70 grade reading level. The results from the SMOG Readability Formula (NCCLS GP 14-A Labeling of Home-Use In Vitro Testing Products) confirmed that the MyAllergyTest™ package was written at a 7th grade reading level.
Conclusion:
These studies demonstrate the substantial equivalence of the MyAllergyTest™ to a currently marketed device that has been reviewed and cleared through the 510(k) notification process.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 9 2002
Ms. Vivianne Noetzel ImmuneTech Corporation P.O. Box 9433 Rancho Santa Fe, CA 92067
Re: K021698
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: July 8, 2002 Received: August 23, 2002
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 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 (OS) 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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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 v 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" (21CFR 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".
Sincerely yours,
Steven Butman
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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5/14//2002
6. INDICATIONS FOR USE STATEMENT
K02 / 698 510(k) Number:
MyAllergyTest™ Device Name:
Indications for 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 MyAllergyTest™ is intended for use with the MyAllergyTest™ System. The MyAllergyTest™ is intended for home use by the lay consumer (Over-the-Counter).
Soushn S. Altare
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
§ 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.