510(k) · Cleared
ClearedRoche Diagnostics Cobas Elecsys Prolactin II Calset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JIT Calibrator, Secondary
Cleared on Oct 28, 2005 as substantially equivalent to K964748 (Boehringer Mannheim Corp., 1997) after a 4-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Oct 28, 2005
- Review
- 4 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900695 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK900695 Enzymun Test (R) ProlactinBoehringer Mannheim Corp. · 1990
- 1 generation backK964748 Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
- This deviceK052982 Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005
- Descendant · cites it directly · 0 of its ownK163544 Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900695 | Enzymun Test (R) Prolactin | Boehringer Mannheim Corp. | 1990 | — |
| −1 | K964748 | Elecsys Prolactin Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K052982 | Roche Diagnostics Cobas Elecsys Prolactin II Calset | Roche Diagnostics | 2005 | — |
| +1 | K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 JIT? 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 |
|---|---|---|---|
| * | K964748 | Elecsys Prolactin AssaySummary page 2…CalSet is equivalent to other devices legally Device marketed in the United States. We claim equivalence to the Elecsys Prolactin CalSet (K964748). Device The table below illustrates the similarities between the Elecsys Prolactin Comparison (K964748) an… | 1997 |
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 |
|---|---|---|---|
| K163544 | Lumipulse G Prolactin | 2017 | 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 15 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163544 (Fujirebio Diagnostics,Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052982: Roche Diagnostics Cobas Elecsys Prolactin II Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052982
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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