MODIFICATION TO MYALLERGY TEST

K061979 · Immunetech Corporation · JKA · Sep 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061979
• Device Name: MODIFICATION TO MYALLERGY TEST
• Applicant: Immunetech Corporation
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Special
• 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 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; enables lay consumers to collect capillary blood at home; samples mailed to clinical laboratory for allergen-specific IgE profile testing; system used in conjunction with MyAllergyTest system (K020387); modification extends sample stability window from 10 to 30 days; device facilitates remote diagnostic testing; no changes to kit components.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing confirming sample stability for the extended 30-day period.

Technological Characteristics

Sample collection kit; physical components unchanged from predicate. Modification is limited to labeling/limitations regarding sample stability duration (30 days).

Indications for Use

Indicated for the collection of whole blood samples for laboratory testing. No specific patient population, age, or disease state contraindications provided.

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

• MyAllergyTest system (K020387)

Submission Summary (Full Text)

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| 6/21/06 | MyAllergyTest® | Page 2 of 5 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Special 510K Device Modification | |
| 510K Number: | K061979 | |
| Submitter: | ImmuneTech Corporation<br>Nancy Benson<br>888 Oak Grove Ave.<br>Suite 4<br>Menlo Park, CA 94025<br>[e-mail]<br>650-233-0653 (home)<br>650-274-5884 (cell) | SEP 2 2 2006 |
| Manufacturing Site: | ImmuneTech Corporation<br>888 Oak Grove Ave.<br>Suite 4<br>Menlo Park, CA 94025<br>650-470-7420<br>650-470-7423 (FAX) | |

Device Product Code: JKA

## Description of the modified device:

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.

#### 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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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 [phone]. 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 [phone] or [phone] 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:

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.

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