510(k) · Cleared
ClearedImmulite Latex-Specific Ige
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Nov 18, 1996 as substantially equivalent to K931746 (Diagnostic Products Corp., 1995) after a 91-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 18, 1996
- Review
- 91 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931746 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK931746 Latex (K82)Diagnostic Products Corp. · 1995
- This deviceK963245 Immulite Latex-Specific IgeDiagnostic Products Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931746 | Latex (K82) | Diagnostic Products Corp. | 1995 | — |
| 0 (this device) | K963245 | Immulite Latex-Specific Ige | Diagnostic Products Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K931746 | Latex (K82)Summary page 1…tion Number: DPC's Registration Number is 2017183 Substantially Equivalent Predicate Device: Diagnostic Products Corporation's AlaSTAT® EIA Latex-Specific IgE Allergen.(K931746) and AlaSTAT” Microplate Latex-Specific IgE Allergen (K) Description of Device: IMMULITE Latex-Specific IgE is a solid-phase, t… | 1995 |
| * | — | AlaSTAT Microplate Latex-Specific IgE Allergen Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
DPC's IMMULITE Latex-Specific IgE is designed for the semi-quantitative detection of IgE antibodies specific to latex allergen in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
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/K963245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963245: Immulite Latex-Specific Ige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963245
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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