ALLERGEAZE PATCH TEST CHAMBERS

K063160 · Smartpractice · KXF · Dec 22, 2006 · General Hospital

Device Facts

• Record ID: K063160
• Device Name: ALLERGEAZE PATCH TEST CHAMBERS
• Applicant: Smartpractice
• Product Code: KXF · General Hospital
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6025
• Device Class: Class 1

Intended Use

Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin

Device Story

AllergEAZE™ Patch Test Chambers function as an allergen delivery system. The device provides a physical means to hold and apply allergens or allergen mixes directly to the patient's skin surface. It is intended for use by healthcare professionals in a clinical setting to facilitate patch testing procedures. By maintaining contact between the allergen and the skin, the device enables the assessment of potential allergic reactions. The device is a passive delivery tool; it does not involve electronic processing, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an absorbent tipped applicator designed for topical allergen delivery. It functions as a passive chamber system for skin contact. No electronic components, software, or energy sources are utilized.

Indications for Use

Indicated for use as an allergen delivery system to place allergens or allergen mixes in contact with the skin surface for patch testing.

Regulatory Classification

Identification

An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2024

SmartPractice Kim Sullivan Vice President Regulatory/Research and Product Development 3400 East McDowell Road Phoenix, Arizona 85008

Re: K063160

Trade/Device Name: AllergEAZE™ Patch Test Chambers Regulation Number: 21 CFR 880.6025 Regulation Name: Absorbent tipped applicator Regulatory Class: Class I Product Code: KXF

Dear Kim Sullivan:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 22, 2006. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code KXF.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.

Sincerelv.

David Wolloscheck -S

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a semi-circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim Sullivan Vice President Regulatory/Research and Product Development SMARTPRACTICE 3400 East McDowell Road Phoenix, Arizona 85008

DEC 2 2 2006

Re: K063160

Trade/Device Name: AllergEAZE™ Patch Test Chambers Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LDH Dated: October 13, 2006 Received: October 17, 2006

Dear Ms. Sullivan:

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 regulytions affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 tar898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

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 ogencies. You must comply with all the Act's requirements, including, but not imited to: registerior and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing rogistice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 82p1 cend if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Parts to the regulation may obtain other general information on your responsibilities under the Act form the Division of Small Manufacturers, International and Consumer Assistance at its toll the number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Shule H. Murphy, MD for Chen Lean Ph D 12/22/06

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

K063160

Device Name:

allergEAZE™ Patch Test Chambers

Indications For Use: Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cun 20

112015000 Cars

K963164

Page 1 of 1

3