510(k) · Cleared
ClearedUnicap 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Sep 12, 1996 after a 91-day review. The FDA summary names its predicate without a number. 37 later devices descend from it.
- Decided
- Sep 12, 1996
- Review
- 91 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 17 citing it directly.
- This deviceK962274 Unicap 100Pharmacia, Inc. · 1996
- Descendant · cites it directly · 30 of its ownK051218 Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005 · Recalled
- Descendant · cites it directly · 2 of its ownK991048 Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208…Pharmacia & Upjohn Co. · 1999
- 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 ownK113841 Immunocap Allergen Components BundlePhadia US, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK101251 Immunocap Allergen D202, Allergen Component Nder P 1, House Dust…Phadia AB · 2011
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005 · cites it directly30descendants
- K991048Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…Pharmacia & Upjohn Co. · 1999 · cites it directly2descendants
- K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB · 2016 · 2 generations on1descendant
- K113841Immunocap Allergen Components BundlePhadia US, Inc. · 2012 · cites it directly1descendant
- K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap…Phadia AB · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962274 | Unicap 100 | Pharmacia, Inc. | 1996 | — |
| +1 | K051218 | Modification to: Unicap Specific Ige | Pharmacia Diagnostics AB | 2005 | 3 |
| +1 | K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210… | Pharmacia & Upjohn Co. | 1999 | — |
| +2 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… | Phadia AB | 2016 | 1 |
| +1 | K113841 | Immunocap Allergen Components Bundle | Phadia US, Inc. | 2012 | — |
| +1 | K101251 | Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite… | Phadia AB | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 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? (7)
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 RAST FEIA Named without a submission number | |
| * | — | Positioning Guide 96 Named without a submission number | |
| * | — | AutoCAP Named without a submission number | |
| * | — | FluoroCount 96 Named without a submission number | |
| * | — | MasterCAP Named without a submission number | |
| * | — | Pharmacia Specific IgE Control Named without a submission number | |
| * | — | Phadexact Negative Control Named without a submission number |
What descends from it? (37)
See all 3717 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051218 | Modification to: Unicap Specific Ige | 2005 | 30 |
| K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216… | 1999 | 2 |
| K113841 | Immunocap Allergen Components Bundle | 2012 | 1 |
| K101251 | Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap… | 2011 | 1 |
| K081830 | Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check… | 2009 | 1 |
| K974580 | Allergen Immunocap F256,F245,F207,F202 | 1998 | 1 |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230… | 2019 | 0 |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | 2018 | 0 |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | 2017 | 0 |
| K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440… | 2015 | 0 |
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, K051218 (Pharmacia Diagnostics AB, 2005) has gone furthest, with 30 descendants of its own.
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.
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?
UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific 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 findings, and is to be used in clinical laboratories, as well as, physician office laboratories. UniCAP 100 is…
Read the full statement (230 words)
UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific 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 findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
UniCAP 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results.
UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server.
Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA.
Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.
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/K962274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962274: Unicap 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962274
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