510(k) · Cleared
ClearedPharmacia Cap System Rast Feia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Dec 23, 1996 as substantially equivalent to K953014 (Diagnostic Products Corp., 1995) after a 145-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Dec 23, 1996
- Review
- 145 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953014 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- This deviceK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- Descendant · cites it directly · 3 of its ownK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK030590 Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK121463 Immunocap Allergen K82Thermo Fisher Scientific · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK051677 Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K972068Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997 · cites it directly3descendants
- K030590Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003 · 2 generations on1descendant
- K121463Immunocap Allergen K82Thermo Fisher Scientific · 2013 · 2 generations on0descendants
- K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| 0 (this device) | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| +1 | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | Pharmacia, Inc. | 1997 | — |
| +2 | K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82) | Hitachi Chemical Diagnostics, Inc. | 2003 | — |
| +2 | K121463 | Immunocap Allergen K82 | Thermo Fisher Scientific | 2013 | 1 |
| +3 | K051677 | Optigen Allergen Specific Ige Assay | Hitachi Chemical Diagnostics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K953014 | Alastat Microplate Latex-Specific Ige AllergenSummary page 1…ivalent to: The clinical diagnosis of latex allergy and AlaSTAT" Microplate Latex-Specific Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045 K953014 ,“qu Pharmacia & Upjohn VIi. SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Intended Use: Pharmacia CAP Syste… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | 1997 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K972068 (Pharmacia, Inc., 1997) has gone furthest, with 3 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?
Pharmacia CAP System RAST FEIA is an in vitro test which measures the concentration of circulating allergen specific IgE in human blood samples.
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/K962976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962976: Pharmacia Cap System Rast Feia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962976
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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