Tryptase Assay System
The Tryptase Assay System is an in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with suspected systemic mastocytosis, used in conjunction with other clinical and laboratory findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OYL, with regulation number 866.5760 under the Immunology medical specialty.
Basic Information
- Product Code
- OYL
- Device Class
- FDA class 2
- Regulation Number
- 866.5760
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | Mar 02, 2018 | Substantially Equivalent | Phadia AB |
| DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE | Feb 15, 2012 | Unknown | Phadia US, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.