510(k) · Cleared
Recalled · Class III · 2012Optigen Allergen Specific Ige Assay
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 Jan 23, 2006 as substantially equivalent to K030590 (Hitachi Chemical Diagnostics, Inc., 2003) and 1 other predicate after a 216-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Jan 23, 2006
- Review
- 216 days
- Class
- Class II
- Product code
- DHB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953014 (1995). 6 ancestors in all, the oldest K914850 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- 3 generations backK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- 2 generations backK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- 1 generation backK030590 Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003
- This deviceK051677 Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| −3 | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K051677 | Optigen Allergen Specific Ige Assay | Hitachi Chemical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Summary page 2…6. Substantial Equivalence to: Assay a. Hitachi Chemical Diagnostics, CLA Allergen-Specific IgE Assay - Latex Allergen K82 (K030590) b. Pharmacia, Inc., UniCAP Specific IgE Assay (K962274) 7. Device Description a. The OPTIGEN® Aller… | 2003 |
| * | K962274 | Unicap 100Summary page 2…a. Hitachi Chemical Diagnostics, CLA Allergen-Specific IgE Assay - Latex Allergen K82 (K030590) b. Pharmacia, Inc., UniCAP Specific IgE Assay (K962274) 7. Device Description a. The OPTIGEN® Allergen-Specific IgE Assay is a solid phase in vitro test… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2012 | Class III | Z-0793-2013 | Process control | There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
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 OPTIGEN assay is an in vitro test, which provides a semi quantitative
measurement of circulating allergen specific IgE antibodies in human serum. The
OPTIGEN assay is intended to assist in the clinical diagnosis of IgE-mediated allergic
disorders. This device is designed for use in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051677: Optigen Allergen Specific Ige Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051677
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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