510(k) · Cleared
ClearedUnicap Specific Ige Feia Assay, Latex Allergen Immunocap K82
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 Jul 3, 1997 as substantially equivalent to K962976 (Pharmacia & Upjohn Co., 1996) after a 30-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953014 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- 1 generation backK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- This deviceK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK030590 Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK121463 Immunocap Allergen K82Thermo Fisher Scientific · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK051677 Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K030590Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003 · cites it directly1descendant
- K121463Immunocap Allergen K82Thermo Fisher Scientific · 2013 · cites it directly0descendants
- K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| −1 | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| 0 (this device) | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | Pharmacia, Inc. | 1997 | — |
| +1 | K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82) | Hitachi Chemical Diagnostics, Inc. | 2003 | — |
| +1 | K121463 | Immunocap Allergen K82 | Thermo Fisher Scientific | 2013 | 1 |
| +2 | K051677 | Optigen Allergen Specific Ige Assay | Hitachi Chemical Diagnostics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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 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 |
|---|---|---|---|
| * | K962976 | Pharmacia Cap System Rast FeiaSummary page 2…Code Class CFR UniCAP Specific IgE Assay, 82 DHB II 866.5750 Latex Allergen ImmunoCAP k82 tial ival Pharmacia CAP System RAST® FEIA Latex Allergen ImmunoCAP k82 510(k) K962976. Intended Use Statement: UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen speci… | 1996 |
What descends from it? (3)
2 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K030590 (Hitachi Chemical Diagnostics, Inc., 2003) has gone furthest, with 1 descendant 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 Specific IgE Assay, Latex k82 test result may be used as an aid in the clinical diagnosis of patients with suspected latex allergy.
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/K972068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972068
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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