510(k) · Cleared
ClearedCla Allergen-Specific Ige Assay-Latex Allergen (K82)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Mar 21, 2003 as substantially equivalent to K914850 (Mast Immunosystems, 1991) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Mar 21, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953014 (1995). 4 ancestors in all, the oldest K914850 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- 2 generations backK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- 1 generation backK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- This deviceK030590 Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK051677 Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| −2 | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| −1 | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | Pharmacia, Inc. | 1997 | — |
| 0 (this device) | K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82) | Hitachi Chemical Diagnostics, Inc. | 2003 | — |
| +1 | K051677 | Optigen Allergen Specific Ige Assay | Hitachi Chemical Diagnostics, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K914850 | Chemiluminescent System Allergan Specific IgeSummary page 2…Substantial Equivalence to: a. Hitachi Chemical Diagnostics, formerly MAST Immunosystems, CLA Allergen Specific IgE Assay System (K914850) b. UniCAP Specific IgE FEIA Assay, Latex Allergen (K972068) 7. Device Description… | 1991 |
| * | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Summary page 2…, formerly MAST Immunosystems, CLA Allergen Specific IgE Assay System (K914850) b. UniCAP Specific IgE FEIA Assay, Latex Allergen (K972068) 7. Device Description a. The CLA@ Allergen-Specific IgE Assay is a solid phase in vitro test… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051677 | Optigen Allergen Specific Ige Assay | 2006 | 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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051677 (Hitachi Chemical Diagnostics, Inc., 2006) has gone furthest, with 0 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?
The CLA@Allergen-Specific IgE Assay is a single use in vitro test for the semi quantitative determination of circulating allergen-specific IgE concentrations in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030590
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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