510(k) · Cleared
Recalled · 2012Immulite 1000 Automated Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Aug 21, 2002 as substantially equivalent to K905215 (Cirrus Diagnostics, Inc., 1991) after a 15-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 21, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- CEW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905215 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK905215 Immulite (TM) Automated Immunoassay AnalyzerCirrus Diagnostics, Inc. · 1991
- This deviceK022603 Immulite 1000 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 2002
- Descendant · cites it directly · 0 of its ownK032881 Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total…Diagnostic Products Corp. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905215 | Immulite (TM) Automated Immunoassay Analyzer | Cirrus Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K022603 | Immulite 1000 Automated Immunoassay Analyzer | Diagnostic Products Corp. | 2002 | — |
| +1 | K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone | Diagnostic Products Corp. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 CEW? 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 CEW device
- #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.7 · 3 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 |
|---|---|---|---|
| * | K905215 | Immulite (TM) Automated Immunoassay AnalyzerSummary page 2…Instrument Systems Division Registration Number is 2247 1 17 Substantiallv Equivalent Predicate Device: IMMULITE (K9052 15) Description of Device: IMMULITE 1000 Automated Immunoassay Analyzer Intended Use of the Device: These modificat… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2012 | Not classified | Z-1700-2012 | Component change control | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| Apr 30, 2012 | Not classified | Z-1701-2012 | Component change control | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K032881 (Diagnostic Products Corp., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEW
160in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEW
37in 2025
MAUDE reports naming product code CEW, 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 | 4 | 160 | 1 | 0 |
| 2008 | 0 | — | 1 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 3 | 23 |
| 2011 | 0 | — | 0 | 97 |
| 2012 | 1 | — | 0 | 124 |
| 2013 | 2 | — | 1 | 172 |
| 2014 | 1 | — | 0 | 167 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 0 | — | 2 | 98 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 65 |
| 2019 | 1 | — | 0 | 77 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 2 | 188 |
| 2023 | 1 | — | 0 | 82 |
| 2024 | 2 | — | 2 | 67 |
| 2025 | 0 | — | 1 | 37 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022603: Immulite 1000 Automated Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022603
Report an extraction error
Are you the manufacturer?
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