510(k) · Cleared
ClearedImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on May 14, 2019 as substantially equivalent to K051218 (Pharmacia Diagnostics AB, 2005) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 14, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962274 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DHB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DHB device
- #1 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage…score 12.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K051218 | Modification to: Unicap Specific IgeSummary page 5…age 5 === Traditional 510(k) Submission, ImmunoCAP Allergen Components rCan f 4, rCan f 6 and rFel d 7 A.6 510k Summary_SSedit 52319 Substantial Equivalence to: K051218, K962274 ImmunoCAP Specific IgE - ImmunoCAP Allergen e5, Dog dander (14-4110-01) - ImmunoCAP Allergen e1,… | 2005 |
| * | K962274 | Unicap 100Summary page 5…Traditional 510(k) Submission, ImmunoCAP Allergen Components rCan f 4, rCan f 6 and rFel d 7 A.6 510k Summary_SSedit 52319 Substantial Equivalence to: K051218, K962274 ImmunoCAP Specific IgE - ImmunoCAP Allergen e5, Dog dander (14-4110-01) - ImmunoCAP Allergen e1, Cat dand… | 1996 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 13.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 26 other devices also cite its predicate K051218.
How does its category compare?
All DHB devicesDHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DHB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DHB
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHB
14in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHB
6in 2025
MAUDE reports naming product code DHB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 7 | 118 | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 5 | 405 | 0 | 1 |
| 2012 | 3 | 260 | 1 | 2 |
| 2013 | 5 | 257 | 0 | 0 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 1 | 11 |
| 2018 | 2 | — | 1 | 6 |
| 2019 | 3 | 90 | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 2 | — | 3 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 2 | — | 14 | 6 |
| 2026 | 6 | 138 | 0 | — |
What is it indicated for?
ImmunoCAP Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instrument Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190315: ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190315
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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