# K022603: Immulite 1000 Automated Immunoassay Analyzer

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 21, 2002 after 15 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905215 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905215: Immulite (TM) Automated Immunoassay Analyzer, Cirrus Diagnostics, Inc. (1991) Summary page 2.

## Most influential descendants
- K032881: Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone (2003), 0 descendants of its own

## Recalls of this device
- Apr 30, 2012 · Not classified · Z-1700-2012: Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
- Apr 30, 2012 · Not classified · Z-1701-2012: Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.

## Indications for use
The DPC MMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.

Source page: https://510kreport.com/device/K022603
Methodology: https://510kreport.com/methodology