510(k) · Cleared
Recalled · Class II · 2014Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Aug 28, 2013 as substantially equivalent to K051218 (Pharmacia Diagnostics AB, 2005) and 1 other predicate after a 400-day review. Its family tree reaches back 2 generations to 1996. It has been recalled once.
- Decided
- Aug 28, 2013
- Review
- 400 days
- Class
- Class II
- Product code
- DHB
- Recalls
- 1
- 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 Ige | 2005 |
| * | K962274 | Unicap 100Summary page 2…11 CFR 866.5750 Substantial Equivalence to: ImmunoCAP Specific IgE (kOS51218) ImmunoCAP Allergens (k962274) indications For Use Statement ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specifi… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2014 | Class II | Z-0947-2015 | Software design | During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 8.7 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. 2013, 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 is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500, Phadia 5000. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122197: Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122197
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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