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.

Device Description

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

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

Epitest Limited Oy c/o Clawson Bowman Vice President, Regulatory Affairs and Clinical Affairs 1330A Redwood Way Petaluma, California 94954-1169

November 1, 2024

Re: K013820

Trade/Device Name: Finn Chamber® Regulation Number: 21 CFR 880.6025 Regulation Name: Absorbent tipped applicator Regulatory Class: Class I Product Code: KXF

Dear Clawson Bowman:

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 January 30, 2002. 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Epitest Limited Oy C/O Mr. Clawson Bowman Vice President, Regulatory and Clinical Affairs Dow Pharmaceutical Sciences 1330A Redwood Way Petaluma, California 94954-1169

Re: K013820

Trade/Device Name: Finn Chamber ® Regulation Number: None Regulation Name: Allergen and Vaccine Delivery System Regulatory Class: Unclassified Product Code: LDH Dated: November 15, 2001 Received: November 16, 2001

Dear Mr. Bowman:

We have reviewed your Section 510(k) premarket notification of intent to market the device the device We have reviewed your Secuon 510(x) profix) is substantially equivalent (for the referenced above and have determined the develop predicated predicate devices marketed in
indications for use stated in the enclosure) to legally madical Device indications for use stated in the checked to to regioned date of the Medical Device interstate commerce prior to May 20, 1970, the sitived in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approval of a Amendments, or to devices that have been received to ret require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that douice, subject to the general the Federal Food, Drug, and Cosinent Act (recree, market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the approval application (FMA). Tou may, includes provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing practice, requirements for annials against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional voluless, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Federal your device can be found in the Code of Pederal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substanian oque ransplies with other requirements

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Page 2 - Mr. Bowman

of the Act or any Federal statutes and regulations administered by other Federal agencies.
The segment of the Malantations and reguirements, including, but not limited to: re of the Act or any Federal statutes and regulations administered by out not limited to: registration
You must comply with all the Act's requirements, including, but not limite of the rest comply with all the Act's requirements, including, out mor mintening practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practi I ca listing (21 CFR Part 807); abeling (21 CFR Part 801); good marker (21 CFR Part 820); and if
requirements as set forth in the quality systems (OS) regulation (21 CFR Part and fishing (S) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 21 CFR 1000-1050.

21 Or Section will allow you to begin marketing your device as described in your Section. This letter will allow you to begin marketing your device as described in your device to
510(k) premarket notification. The FDA finding of substantial equivalence of your de 510(k) premarket notification. The FDA Inding of substance quarter and thus,
a legally marketed predicate device results in a classification for your device and thus,
a lega a legally marketed proceed to the market.

permise specific advice for your device on our labeling regulation (21 CFR Part 801
CFR Partificant and Review 800 10 for in vitro diagnostic devices), please contact the If you desire specific advice for your device on our labentify regimss). please contact the
and additionally 21 CFR Part 809.10 for in vitro diagnostic devices in the promoti If you asono if
Office of Compliance (301) 594-4618. Additionally, for questions on the promotion and
Office of Compliance and 301) 594-4618. Additionally, for questions on Office of Compliance at (301) 594-4618. Adaltonally, for quisate at (301) 594-4639.
advertising of your device, please contact the Office of Compliance at (301) 594-4639.
ad advertising of your device, please contact the Ontice of Complete of preference to premarket.
Also, please note the regulation entitled, "Misbranding by reference to Also, please note the regulation entitled, "Misfrancing by recense on responsibilities under
notification" (21CFR Part 807.97). Other general information on your responsibil notification" (21CFR Part 807.97). Other general information of Small Manufacturers, International and
the Act may be obtained from the Division of Small Manufacturers, Inte the Act may be obtained from the Division of Small Manufacturers, 2001 443-6597 or at its
the Act may be obtained from the Division of S00) 638-2041 or (301) 443-6597 or at i Consumer Assistance at its toll-free number (800) 030 2012 (1888) (1888) 1987 (1987) 1987) 1987 (1987) 1987) 1987

Sincerely yo

A. Ulatowski Th Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Dow Pharmaceutical Sciences

Kol3820

B. Statement of Indication for Use

Applicant: Epitest Ltd Oy

510(k) Number: not-known 长۵۱ 38 Q 0

Device Name: Finn Chamber®

Indication For Use:

Finn Chamber® is an aluminum holding device to place allergens and allergen mixes
and allering and and the most the tasting Finil Chambers is an face of skin during allergen patch testing.

This product is intended for use by or under the supervision of a physician in the This product is intended for use by or under the super research of the not intended for over-thecounter use.

Patrovo Ciccerite

Division Sign-Off) Division Sign-only Infection Control,
Division of Dental, Infection Control, Division General Hospital Devices 810 General Hoston Kol3820

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K013820 510(k) Premarket Notification Finn Chamber®

C. 510(k) Summary	JAN 3 0 2002
Submitter:	Dow Pharmaceutical Sciences1330A Redwood WayPetaluma, CA 94954(707) 793-2600
	On Behalf of:Epitest Ltd OyRannankoukku 22FIN-04300 Tuusula, Finland
Contact:	Clawson Bowman, J.D.Vice President, Regulatory and Clinical Affairs
Date:	November 15, 2001
Device Name:	Finn Chamber®
Classification Name:	Allergen and Vaccine Delivery System
Predicate Device:	IQ Chamber (K992553) (Dormer Laboratories, Inc.)

Description:

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 substantially equivalent to various marketed allergen and vaccine delivery systems including IQ Chamber (K992553).

Regulation Number and Section

§ 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.