Cleared Traditional

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip

K173704 · Phadia AB · Immunology

Mar 2018

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K173704 is an FDA 510(k) clearance for the ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip, a Tryptase Assay System (Class II — Special Controls, product code OYL), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 2, 2018, 88 days after receiving the submission on December 4, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5760.

Submission Details

510(k) Number	K173704 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2017
Decision Date	March 02, 2018
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	OYL — Tryptase Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5760
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.