(66 days)
Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
Not Found
This is a 510k document for the AllergEAZE™ Patch Test Chambers. This document is a clearance letter from the FDA, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. This letter does not describe a clinical study or performance evaluation in the way a scientific paper or a more detailed regulatory submission might.
The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate, rather than presenting a detailed performance study with acceptance criteria and a study design.
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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
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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.
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
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Indications for Use
510(k) Number (if known):
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 _
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 880.6025 Absorbent tipped applicator.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.