510(k) · Cleared
ClearedImmulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-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 Sep 29, 1997 as substantially equivalent to K911511 (Diagnostic Products Corp., 1991) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 29, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911511 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911511 Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp. · 1991
- This deviceK973186 Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite…Diagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911511 | Alastat Allergen Specified Ige System, Modified | Diagnostic Products Corp. | 1991 | — |
| 0 (this device) | K973186 | Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific Ige | Diagnostic Products Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K911511 | Alastat Allergen Specified Ige System, ModifiedSummary page 1…DPC's Registration Number is 2017183 Substantially Equivalent Predicate Device: Diagnostic Products Corporation's AlaSTAT" Microplate Specific IgE for Cat/Dog/Mite (K911511, K954566) 37 rat Description of Device: IMMULITE Cat/Dog/Mite-Specific IgE kits are solid-phase, two-site chemi… | 1991 |
| * | K954566 | Specific Allergen Modules for the Alastat Microplate Allergen-Specific Ige SystemSummary page 1…egistration Number is 2017183 Substantially Equivalent Predicate Device: Diagnostic Products Corporation's AlaSTAT" Microplate Specific IgE for Cat/Dog/Mite (K911511, K954566) 37 rat Description of Device: IMMULITE Cat/Dog/Mite-Specific IgE kits are solid-phase, two-site chemiluminesce… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K911511.
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® Cat/Dog/Mite-Specific IgE kits are clinical use devices intended for use
with the IMMULITE Automated Immunoassay Analyzer to measure circulating levels of
IgE antibodies specific to Cat Epithelium, Dog Dander and Dematophagoides pteronyssinus
in serum. It is intended 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/K973186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973186: Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-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/K973186
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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