IQ CHAMBERS

K992553 · Dormer Laboratories, Inc. · KXF · Apr 12, 2000 · General Hospital

Device Facts

• Record ID: K992553
• Device Name: IQ CHAMBERS
• Applicant: Dormer Laboratories, Inc.
• Product Code: KXF · General Hospital
• Decision Date: Apr 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6025
• Device Class: Class 1

Intended Use

The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.

Device Story

IQ Chamber is a plastic tray featuring shallow indentations/chambers; designed to hold allergens or allergen mixes against patient skin for patch testing. Used exclusively by healthcare professionals in clinical settings; not for OTC use. Device functions as a delivery system to ensure consistent contact between test substances and skin surface. Benefits include standardized application of allergens for diagnostic purposes. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; device is a simple mechanical applicator.

Technological Characteristics

Plastic tray with shallow indentations/chambers. Non-powered, manual application device. No software or electronic components.

Indications for Use

Indicated for use by healthcare professionals to facilitate allergen patch testing by holding allergens or allergen mixes in contact with the skin surface.

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.

Predicate Devices

• Hill Top Chambers (K811365)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features an abstract design. The FDA logo is on the right and includes the agency's acronym in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Dormer Laboratories, Inc. c/o Daniel J. Manelli Farkas & Manelli, PLLC 2000 M. Street, N.W., 7th Floor Washington, District of Columbia 20036-3307 November 1, 2024

Re: K992553

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

Dear Daniel J. Manelli:

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 April 12, 2000. 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.

Sincerely,

# 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}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 2 2000

Dormer Laboratories, Inc. C/O Mr. Daniel J. Manelli Farkas & Manelli, PLLC 2000 M Street, N.W., 7th Floor Washington, D.C. 20036-3307

K992553 Re : IQ Chamber Trade Name: Requlatory Class: I Product Code: LDH Dated: February 22, 2000 February 24, 2000 Received:

Dear Mr. Manelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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

Page 2 - Mr. Manelli

the Federal Register. Please note: this response to your enc redural notification submission does not affect any premarker nociticacron barunder sections 531 through 542 of obligation you might have ahe Electronic Product Radiation che RCC for devices ander er Federal laws or regulations.

This letter will allow you to begin marketing your device as Infs lecter will arrow formarket notification. The FDA described in your 510 th, privalence of your device to a legally rinding of subblancial equalistic in a classification for your marketed predicate device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compriance ac (30) advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the Orrece of compiland, "Misbranding by reference to the regulation entitled, "M.soranding by ecreation eral information on your responsibilities under the Act may be Information on your responsible in Small Manufacturers Assistance obcation from chonoman [phone] or [phone] or at at its coll-free number [phone]-02-1002 (000) 1000 (000) 1000 (000 ) 1000 (000 ) 1

Sincerely yours

U. Celatords

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

Enclosure

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

EXHIBIT 5

Page 1 of 1

510(k) Number (if known): 1992553

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device evaluation (ODE)

Paltrix Vincente

(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Devices 510(k) Number -

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

3

{4}------------------------------------------------

# APR 1 2 2000

EXHIBIT 7

### 510(k) Summary

Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

> On behalf of Dormer Laboratories, Inc. 510(k) Submission: IQ Chamber July 28, 1999

The product is a plastic tray with shallow indentations or chambers for use as a The product is a place allergens or allergen mixes in contact with the surface of the skin during allergen patch tests. .

This product is for use only by health care professionals; it is not intended for OTC rins product is for aso only ,
use. It contains materials that pose no health hazard when used according to directions. The device is substantially equivalent to various marketed allergen and vaccine delivery systems including Hill Top Chambers (K811365)