(41 days)
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.
The Quanti-Test System is an allergen delivery system.
The provided documents are FDA 510(k) letters related to the Quanti-Test System, which is described as an "allergen delivery system" for skin prick tests. These documents are dated from 1998 and an administrative update from 2024. They primarily concern the regulatory classification and substantial equivalence determination for the device, not a study describing acceptance criteria and device performance in the context of recent AI-powered medical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The documents confirm the following about the device:
- Device Name: Quanti-Test System
- Intended Use: An allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.
- Original Product Code (1998): LDH (Unclassified)
- Updated Product Code (2024): SCL (Hypodermic single lumen needle, Class II)
The provided text does not contain any information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone performance of an algorithm.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
These kinds of details are typically found in the 510(k) summary or detailed submission documents, which are not included in the provided snippets.
{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 (301) 594-4692. Additionally, for questions on Compilance at (361) sectising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).