QUANTI-TEST SYSTEM

K982578 · Panatrex, Inc. · SCL · Sep 2, 1998 · General Hospital

Device Facts

• Record ID: K982578
• Device Name: QUANTI-TEST SYSTEM
• Applicant: Panatrex, Inc.
• Product Code: SCL · General Hospital
• Decision Date: Sep 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Quanti-Test System is an allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.

Device Story

Quanti-Test System functions as allergen delivery device for skin prick testing; device introduces antigen into epidermis to assess patient sensitivity to specific allergens; used in clinical settings by healthcare professionals; output consists of localized skin reaction indicating sensitivity; assists clinicians in diagnosing allergic conditions; benefits patients by providing standardized method for allergy identification.

Clinical Evidence

No clinical data provided; device cleared via 510(k) process based on substantial equivalence to existing allergen delivery methods.

Technological Characteristics

Allergen delivery system for skin prick testing; manual application; single-use design; mechanical delivery mechanism.

Indications for Use

Indicated for use as an allergen delivery system to perform skin prick testing to identify sensitivity to allergens in patients.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

November 1, 2024

Panatrex, Incorporated c/o Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, California 92606

Re: K982578

Trade/Device Name: Quanti-Test System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Greg Holland:

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 September 2, 1998. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.

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}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 SEP

Panatrex, Incorporated C/O Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, California 92606

Re : K982578 Quanti-Test System Trade Name: Requlatory Class: Unclassified Product Code: LDH Dated: July 22, 1998 Received: July 23, 1998

Dear Mr. Holland:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceiver been and we have determined the market the device ferences and about (for the indications for device is substantially equivalens ally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, devices marketoa en of the Medical Device Amendments, or to the enactment date of the nassified in accordance with the devices that have been al Food, Drug, and Cosmetic the general provisions of the reacras rosa, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions of the isso andevices, 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 be subject to bacting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ rederal Regulation determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, Devices: General regaspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Administration (21) regulation may result in regulatory In addition, FDA may publish further announcements action. action: "In and device in the Federal Register. Please note: concerning your device in one ification submission does this responded on fight have under sections 531

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

Page 2 - Mr. Holland

through 542 of the Act for devices under the Electronic Chrough 542 or the not rol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis lecter will areas () premarket notification. The FDA described in your see in privalence of your device to a legally finding of substancial equivalies of plassification for your marketed predicate device ruraderice to proceed to the market.

If you desire specific advice for your device on our labeling If you debire bpostar 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Victo diagnosere at [phone]. Additionally, for questions on Compilance at (361) sectising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regardon" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from one momber [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutnam for

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

Enclosure

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

Premarket Notification - Panatrex, Inc.

Page 1 of _1

510(k) Number (if known): ___________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Quanti-Test System is an allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Latricia Crescenti
(Division Sign. Off.)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

OR

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

July 22, 1998