# DEN120001: Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase

- Pathway: De Novo (Post-NSE)
- Applicant: Phadia US, Inc.
- Decided: Feb 15, 2012 after 34 days
- Product code: OYL (Tryptase Assay System)
- Device class: 2
- Regulation: 21 CFR 866.5760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K173704: ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip (2018), 0 descendants of its own
- K132344: E-Z Check Ozone Test Strips (2014), 0 descendants of its own

Source page: https://510kreport.com/device/DEN120001
Methodology: https://510kreport.com/methodology