510(k) · Cleared
Recalled · Class II · 2017Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH
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 Feb 24, 2014 as substantially equivalent to K964152 (Pharmacia, Inc., 1997) after a 110-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 24, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- DGC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964152 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964152 Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHPharmacia, Inc. · 1997
- This deviceK133404 Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve…Phadia AB · 2014
- Descendant · cites it directly · 1 of its ownK161899 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip…Phadia AB · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK231151 Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH | Pharmacia, Inc. | 1997 | — |
| 0 (this device) | K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control… | Phadia AB | 2014 | — |
| +1 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… | Phadia AB | 2016 | 1 |
| +2 | K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHSummary page 1…OGO Class 11 CIFR 866.5510 Substantial Equivalence to: ImmunoCAP Total IgE k964152 Thermo Fsher 2(2) S CIE N TI FI C In… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE… | 2016 | 1 |
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. |
| 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?
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or 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.
ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133404
Report an extraction error
Are you the manufacturer?
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