510(k) · Cleared
Recalled · 2009Immulite 2500 Automated Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Dec 12, 2003 as substantially equivalent to K970227 (Dpc Cirrus, 1997) after a 67-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 3 times.
- Decided
- Dec 12, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970227 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970227 Immulite 2000 Automated Immunoassay AnalyzerDpc Cirrus · 1997 · Recalled
- This deviceK033234 Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970227 | Immulite 2000 Automated Immunoassay Analyzer | Dpc Cirrus | 1997 | 13 |
| 0 (this device) | K033234 | Immulite 2500 Automated Immunoassay Analyzer | Diagnostic Products Corp. | 2003 | — |
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 DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 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 |
|---|---|---|---|
| * | K970227 | Immulite 2000 Automated Immunoassay AnalyzerSummary page 2…trument Systems Division Registration Number: 2247117 Substantially Equivalent Predicate Device: IMMULITE 2000 (K970227) Description of Device: IMMULITE 2500 Automated Immunoassay… | 1997 |
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 |
|---|---|---|---|---|
| Oct 21, 2009 | Not classified | Z-1033-2010 | Nonconforming Material/Component | The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with… |
| Jan 5, 2009 | Not classified | Z-1399-2009 | Process design | Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper. |
| Oct 29, 2004 | Not classified | Z-0263-05 | Other | Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K970227.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DPC IMMULITE 2500 analyzer is an automated immunoassay system intended
to assay the same broad range of analytes in patient samples as does IMMULITE
2000. The intent of the system is to impart the same automation to the same array of
immunoassays in the same hospital and commercial laboratory settings as
IMMULITE 2000. Examples of the array of assays to be used with the DPC
IMMULITE 2500 are two for which data in support of a claim of substantial
equivalence have been submitted to FDA: hCG (product code: DHA) and TSH (JLW).
The system is intended to produce safe and effective performance when used by
medical laboratory personnel as is the predicate system, IMMULITE 2000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033234: Immulite 2500 Automated Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033234
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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