510(k) · Cleared
Recalled · Class II · 2017ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · DGC Ige, Antigen, Antiserum, Control
Cleared on Jul 28, 2016 as substantially equivalent to K051218 (Pharmacia Diagnostics AB, 2005) and 1 other predicate after a 17-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 28, 2016
- Review
- 17 days
- Class
- Class II
- Product code
- DGC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962274 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962274 Unicap 100Pharmacia, Inc. · 1996
- 1 generation backK051218 Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005 · Recalled
- This deviceK161899 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip…Phadia AB · 2016
- Descendant · cites it directly · 0 of its ownK231151 Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962274 | Unicap 100 | Pharmacia, Inc. | 1996 | — |
| −1 | K051218 | Modification to: Unicap Specific Ige | Pharmacia Diagnostics AB | 2005 | 3 |
| 0 (this device) | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… | Phadia AB | 2016 | — |
| +1 | K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 DGC? 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 DGC device
- #1 K231151 Kenota 1 Total IgE; Kenota 1 (instrument)score 8.0 · 3 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…DHB Class II CFR 866.5750 Substantial Equivalence to: k051218 ImmunoCAP Specific IgE Indications For Use / Intended Use Statement ImmunoCAP Specific IgE is an in vitro quantitati… | 2005 |
| * | K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHSummary page 6…DGC Class II CFR 866.5510 Substantial Equivalence to: k133404 ImmunoCAP Total IgE Indications For Use / Intended Use Statement ImmunoCAP Total IgE is an in vitro test system for… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2017 | Class II | Z-0387-2018 | Device Design | The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K231151 (Kenota, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 26 other devices also cite its predicate K051218.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DGC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DGC
Too few DGC 510(k)s in any year since 2007 to give a median.
Recalls per year · DGC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DGC
2in 2021
MAUDE reports naming product code DGC, 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 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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…
Read the full statement (155 words)
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.
ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum and plasma. 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 Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161899: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161899
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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