# K000299: Dermapik II Skin Test System, Dermapik II (Single Test Device), Polypik II (Multiple Skin Test Device), Dermapik Tray, D

- Pathway: 510(k) (Traditional)
- Applicant: Biomedex, Inc.
- Decided: Apr 28, 2000 after 88 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K000299
Methodology: https://510kreport.com/methodology