510(k) · Cleared
ClearedLumipulse G Prolactin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · JIT Calibrator, Secondary
Cleared on Jan 12, 2017 as substantially equivalent to K052982 (Roche Diagnostics, 2005) after a 27-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 12, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900695 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK900695 Enzymun Test (R) ProlactinBoehringer Mannheim Corp. · 1990
- 2 generations backK964748 Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK052982 Roche Diagnostics Cobas Elecsys Prolactin II CalsetRoche Diagnostics · 2005
- This deviceK163544 Lumipulse G ProlactinFujirebio Diagnostics,Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900695 | Enzymun Test (R) Prolactin | Boehringer Mannheim Corp. | 1990 | — |
| −2 | K964748 | Elecsys Prolactin Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K052982 | Roche Diagnostics Cobas Elecsys Prolactin II Calset | Roche Diagnostics | 2005 | — |
| 0 (this device) | K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K052982 | Roche Diagnostics Cobas Elecsys Prolactin II CalsetSummary page 4…Classification: Class II JIT 75, Clinical Chemistry 21 CFR § 862.1150 Predicate Device: k052982 ROCHE DIAGNOSTICS Cobas Elecsys Prolactin II Calset According to the requirements… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163544: Lumipulse G Prolactin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163544
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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