510(k) · Cleared
Recalled · Class II · 2014Immunocap Allergen K82
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Jan 29, 2013 as substantially equivalent to K972068 (Pharmacia, Inc., 1997) after a 257-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Jan 29, 2013
- Review
- 257 days
- Class
- Class II
- Product code
- DHB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953014 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- 2 generations backK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- 1 generation backK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- This deviceK121463 Immunocap Allergen K82Thermo Fisher Scientific · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| −2 | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| −1 | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | Pharmacia, Inc. | 1997 | — |
| 0 (this device) | K121463 | Immunocap Allergen K82 | Thermo Fisher Scientific | 2013 | — |
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? (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 |
|---|---|---|---|
| * | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Summary page 1…DHB Class 11 CFR 866.5750 Substantial Equivalence to: .ImmunoCAP Allergen k82, Latex (Art. No. 14-4345-01), K972068 Thermo Fsher 2(2) S C IEN T IF IC… | 1997 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K972068.
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 and 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/K121463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121463: Immunocap Allergen K82.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121463
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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