FDA product code OYL: Tryptase Assay System
OYL is the FDA product code for tryptase assay system. It is a Class II device, regulated under 21 CFR 866.5760 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OYL. The average 510(k) review took 88 days (median 88). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Tryptase Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.5760 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OYL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 88 |
Compare with all 510(k) review times · Search every OYL clearance
Top OYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phadia AB | 1 | 2018-03-02 |
Most recent OYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173704 | Phadia AB | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | 2018-03-02 | 88 |
Recalls for OYL devices
openFDA lists no recalls for product code OYL.
Frequently asked questions
What is FDA product code OYL?
OYL is the FDA product code for tryptase assay system. It is a Class II device, regulated under 21 CFR 866.5760 and reviewed by the Immunology panel.
What device class is OYL?
Class II, regulation 21 CFR 866.5760. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYL?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most OYL clearances?
Phadia AB (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OYL
- Run a recall and safety report across every OYL manufacturer
- Watch product code OYL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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