(88 days)
Not Found
Not Found
No
The summary describes a mechanical device for applying allergen test extract and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used to diagnose allergies by applying test extracts, not to treat them.
Yes
The device is described as an "allergen skin test device" used to apply test extract and is intended for allergy practitioners, indicating its use in diagnosing allergies.
No
The device description explicitly states it is an "allergen skin test device and supporting components," indicating it includes physical hardware for applying allergen test extract.
Based on the provided information, the DermaPik II Skin Test System™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The description clearly states that the DermaPik II is an "allergen skin test device" designed to "apply allergen test extract using the puncture technique" directly to the patient's skin (forearms or back). This is an in vivo procedure (performed on a living organism), not an in vitro procedure (performed outside of a living organism, typically in a lab).
- The device is used for applying a substance to the body, not for analyzing a sample taken from the body. The purpose is to introduce an allergen to the skin to observe a reaction, not to analyze a blood sample, urine sample, or other bodily fluid or tissue.
Therefore, the DermaPik II Skin Test System™ is a medical device used for in vivo allergy testing, not an IVD.
N/A
Intended Use / Indications for Use
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur.
Product codes
SCL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearms or back
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
allergy practitioners, professional medical environments such as physician clinics and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
November 1, 2024
Biomedex, Incorporated James L. Thompson Director of Technology 3380 Mistletoe Rd. Dallas, Oregon 97338
Re: K000299
Trade/Device Name: Dermapik II Skin Test System, Dermapik II (Single Test Device) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear James L. Thompson:
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 28, 2000. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three overlapping profiles of human faces, with flowing lines that resemble a ribbon or wave beneath them.
APR 2 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James L. Thompson Director of Technology Biomedex, Incorporated 3380 Mistletoe Road Dallas, Oregon 97338
Re : K000299 Trade Name: DermaPik II Skin Test System, DermaPik II (Single Test Device) Regulatory Class: Unclassified Product Code: LOH Dated: January 21, 2000 Received: January 31, 2000
Dear Mr. Thompson:
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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Thompson
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
| Indications for Use Statement | ||
|---|---|---|
| Indications for Use Statement | Page Contents |
|---|---|
| ------------------------------- | --------------- |
Ver/ 3 - 4/24/96
| Applicant: | Biomedex, Inc. |
|---|---|
| 510(k) Number (if known): | K000299 |
| Device Name: | DermaPik II Skin Test System™ |
Indications For Use:
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur.
Clinical settings appropriate for use of this system would include professional medical environments such as physician clinics and hospitals.
The target population appropriate for use of this system would include both pediatric and adult patients.
As is common in all allergy skin test procedures, this device is appropriate for use on the forearms or back in accordance with commonly accepted practices of physicians trained in allergy skin testing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Lailuna Cuencti
(Division Sign-Off)
Division of
(Olvision Sign-Off)
Division of Dental, Infection Devices Control,
and General Hospital, Devices Control,
S10(k) Number
510(k) Number K000299