510(k) · Cleared
ClearedUnicap Total Ige Assay/Pharmacia Total Ige Controls LMH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia, Inc. · DGC Ige, Antigen, Antiserum, Control
Cleared on Apr 23, 1997 after a 189-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 23, 1997
- Review
- 189 days
- Class
- Class II
- Product code
- DGC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK964152 Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHPharmacia, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK133404 Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve…Phadia AB · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK161899 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip…Phadia AB · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK050493 Quantia IgeBiokit, S.A. · 2005
- Descendant · 3 generations on · 0 of its ownK231151 Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK214068 Quantia IgEBiokit, S.A. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133404Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHPhadia AB · 2014 · cites it directly2descendants
- K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB · 2016 · 2 generations on1descendant
- K050493Quantia IgeBiokit, S.A. · 2005 · cites it directly1descendant
- K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024 · 3 generations on0descendants
- K214068Quantia IgEBiokit, S.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH | Pharmacia, Inc. | 1997 | — |
| +1 | K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control… | Phadia AB | 2014 | 2 |
| +2 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… | Phadia AB | 2016 | 1 |
| +1 | K050493 | Quantia Ige | Biokit, S.A. | 2005 | — |
| +3 | K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024 | — |
| +2 | K214068 | Quantia IgE | Biokit, S.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Pharmacia CAP System IgE FEIA Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K133404 (Phadia AB, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. 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, as well as, physician office laboratories.…
Read the full statement (117 words)
UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. 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, as well as, physician office laboratories.
Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964152: Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964152
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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