510(k) · Cleared
ClearedImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · OYL Tryptase Assay System
Cleared on Mar 2, 2018 as substantially equivalent to DEN120001 (Phadia US, Inc., 2012) after an 88-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Mar 2, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- OYL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120001 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backDEN120001 Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50…Phadia US, Inc. · 2012
- This deviceK173704 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP…Phadia AB · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120001 | Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator… | Phadia US, Inc. | 2012 | — |
| 0 (this device) | K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve… | Phadia AB | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN120001 | Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve…Summary page 4…me ImmunoCAP Tryptase Product code OYL, tryptase assay system Substantial Equivalence to: ImmunoCAP Tryptase DEN120001 (k103039) Phadia AB Page A.6.1 (3) Tr… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN120001.
How does its category compare?
All OYL devicesOYL Tryptase Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OYL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OYL
Too few OYL 510(k)s in any year since 2007 to give a median.
Recalls per year · OYL
No recall names OYL since 2007.
Adverse event reports per year · OYL
No MAUDE report names OYL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). 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. ImmunoCAP Tryptase is to be used with the instrument Phadia 100. ImmunoCAP Tryptase is an in vitro…
Read the full statement (130 words)
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). 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. ImmunoCAP Tryptase is to be used with the instrument Phadia 100.
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). 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. ImmunoCAP Tryptase is to be used with the instrument Phadia 250.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173704: ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026