510(k) · Cleared
Recalled · Class II · 2022Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Oct 10, 2003 as substantially equivalent to K022603 (Diagnostic Products Corp., 2002) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1991. It has been recalled 2 times.
- Decided
- Oct 10, 2003
- Review
- 25 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905215 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK905215 Immulite (TM) Automated Immunoassay AnalyzerCirrus Diagnostics, Inc. · 1991
- 1 generation backK022603 Immulite 1000 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 2002 · Recalled
- This deviceK032881 Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total…Diagnostic Products Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905215 | Immulite (TM) Automated Immunoassay Analyzer | Cirrus Diagnostics, Inc. | 1991 | — |
| −1 | K022603 | Immulite 1000 Automated Immunoassay Analyzer | Diagnostic Products Corp. | 2002 | 2 |
| 0 (this device) | K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone | Diagnostic Products Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 CDZ? 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 CDZ device
- #1 K252728 IDS-iSYS Total Testosteronescore 11.8 · 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? (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 |
|---|---|---|---|
| * | K022603 | Immulite 1000 Automated Immunoassay AnalyzerSummary page 2…egistration Number is 2017 183 Substantially Equivalent Predicate Device: IMMULITE/IMMULITE 1000 Total Testosterone (K022603) IMMULITE 2000 Total Testosterone (K955870) Description of Device: IMMULITE/IMMUL… | 2002 |
| * | K955870 | Immulite Total TestosteroneSummary page 2…IMMULITE/IMMULITE 1000 Total Testosterone (K022603) IMMULITE 2000 Total Testosterone (K955870) Description of Device: IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phas… | 1996 |
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 25, 2022 | Class II | Z-0355-2023 | Process control | Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi… |
| Jan 3, 2006 | Not classified | Z-0528-06 | Other | The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDZ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDZ
141in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDZ
17in 2025
MAUDE reports naming product code CDZ, 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 | 6 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 19 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 7 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 4 | 276 | 0 | 5 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 1 | — | 1 | 5 |
| 2019 | 4 | 141 | 0 | 3 |
| 2020 | 1 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 1 | — | 1 | 3 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 2 | — | 1 | 11 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032881 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032881: Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032881
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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