MY ALLERGY TEST

K021698 · Immunetech Corporation · JKA · Sep 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021698
• Device Name: MY ALLERGY TEST
• Applicant: Immunetech Corporation
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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.

Device Story

MyAllergyTest™ is a sample collection kit for home use by lay consumers; enables collection of capillary blood samples for mailing to a clinical laboratory; facilitates allergen-specific IgE profile testing. Kit includes materials for blood collection and transport. User follows package insert instructions to obtain sample; sample is shipped via US Mail to a laboratory for analysis. Device ensures sample stability for up to seven days during transport. Benefits include convenient, at-home access to allergy testing services.

Clinical Evidence

Bench testing only. Stability studies confirmed whole blood samples remain stable for seven days. Mailing studies confirmed stability during US Mail transit. Consumer studies (n=not specified) confirmed lay users can successfully collect blood samples following package inserts. Consumer comprehension and readability studies confirmed instructions are written at a 7th-grade reading level per SMOG Readability Formula.

Technological Characteristics

Sample collection kit for capillary blood. Includes materials for collection and transport. No electronic components, software, or energy sources. Designed for home use. Performance validated for seven-day sample stability.

Indications for Use

Indicated for lay consumers (home use) for the collection and transport of capillary blood samples to a clinical laboratory for allergen-specific IgE profile testing. Intended for use with the MyAllergyTest™ System.

Regulatory Classification

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.

Predicate Devices

• Appraise-Cardio Sample Collection Kit (K993787)

Reference Devices

• MyAllergyTest™ System (K020387)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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