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Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-thecounter use.

Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing.

The provided text is a 510(k) premarket notification for the Finn Chamber® device, which is an aluminum holding device for allergen patch testing. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically associated with the evaluation of a device's performance against specific acceptance criteria.

The document primarily focuses on:

• Regulatory communication: An administrative change to the product code (K013820).
• Substantial Equivalence (SE) determination: A letter from the FDA stating that the Finn Chamber® is substantially equivalent to a legally marketed predicate device (IQ Chamber, K992553).
• Intended Use: "Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-the-counter use."

Since this is a substantial equivalence determination for a Class I device and not a performance study report, the requested information (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text. The FDA's determination of substantial equivalence for this device does not typically require the submission of clinical performance data in the same way that novel or higher-risk devices might.

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