(66 days)
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No
The summary describes a physical allergen delivery system and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
This device is for delivering allergens to the skin for testing or diagnostic purposes, not for treating a disease or condition.
No
The device is an allergen delivery system for placing allergens in contact with the skin, which is a therapeutic or experimental function, not a diagnostic one. It doesn't appear to analyze or interpret any physiological data to diagnose a condition.
No
The intended use describes a physical system ("Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin"), implying a hardware component is involved in the delivery mechanism.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "place allergens or allergen mixes in contact with the surface of the skin." This describes a method of in vivo (within a living organism) testing, specifically skin testing for allergies.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside of the body.
The device's function is to facilitate a test performed directly on the patient's skin, not on a sample taken from the patient. Therefore, it falls outside the definition of an IVD.
N/A
Intended Use / Indications for Use
Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
Product codes (comma separated list FDA assigned to the subject device)
KXF, LDH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skin
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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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
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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.
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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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