510(k) · Cleared
ClearedImmulite 2000 Psa Calibration Verification Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 12, 2013 as substantially equivalent to K112603 (Beckman Coulter, Inc., 2011) after a 75-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Aug 12, 2013
- Review
- 75 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993210 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993210 Access Hybritech Free Psa QC, Model 37219Beckman Coulter, Inc. · 2000
- 1 generation backK112603 Access Hybritech P2PSA QC on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2011
- This deviceK131536 Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK133816 Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133816Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993210 | Access Hybritech Free Psa QC, Model 37219 | Beckman Coulter, Inc. | 2000 | — |
| −1 | K112603 | Access Hybritech P2PSA QC on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2011 | — |
| 0 (this device) | K131536 | Immulite 2000 Psa Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K133816 | Immulite 2000 Free Psa Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K112603 | Access Hybritech P2PSA QC on the Access Immunoassay SystemsSummary page 2…erial I. Substantial Equivalence -Information: 1. Predicate Device Name: Access Hybritech p2PSA OC 2. Predicate 510(k) No. k112603 3. Comparison with A comparison of the device features, intended use, and other Predicate:… | 2011 |
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 |
|---|---|---|---|
| K133816 | Immulite 2000 Free Psa Calibration Verification Material | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133816 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112603.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMULITE® 2000 PSA Calibration Verification Material (CVM) is intended for monitoring
system performance of the IMMULITE Immunoassay system for the quantitative measurement of
PSA antigen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131536: Immulite 2000 Psa Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131536
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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