# K033234: Immulite 2500 Automated Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 12, 2003 after 67 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970227 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970227: Immulite 2000 Automated Immunoassay Analyzer, Dpc Cirrus (1997) Summary page 2.

## Recalls of this device
- Oct 21, 2009 · Not classified · Z-1033-2010: 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 incompatibi
- Jan 5, 2009 · Not classified · Z-1399-2009: 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: Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.

## Indications for use
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.

Source page: https://510kreport.com/device/K033234
Methodology: https://510kreport.com/methodology