Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5760](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5760) → OYL — Tryptase Assay System

# OYL · Tryptase Assay System

_Immunology · 21 CFR 866.5760 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OYL

## Overview

- **Product Code:** OYL
- **Device Name:** Tryptase Assay System
- **Regulation:** [21 CFR 866.5760](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5760)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.

## Classification Rationale

Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.” For availability of the document, see § 866.1(e).

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.” For availability of the document, see § 866.1(e).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K173704](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OYL/K173704.md) | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | Phadia AB | Mar 2, 2018 | SESE |
| [DEN120001](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OYL/DEN120001.md) | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE | Phadia US, Inc. | Feb 15, 2012 | DENG |

## Top Applicants

- Phadia AB — 1 clearance
- Phadia US, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OYL](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OYL)

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