510(k) · Cleared
ClearedFujirebio Diagnostics Tumor Marker Control Model 108-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 5, 2010 as substantially equivalent to K082036 (Bio-Rad Laboratories, 2008) and 1 other predicate after a 98-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Oct 5, 2010
- Review
- 98 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940433 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK940433 Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 1994
- 4 generations backK983807 Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998
- 3 generations backK992172 Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999
- 2 generations backK011579 Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001
- 1 generation backK082036 Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008
- This deviceK101809 Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940433 | Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 | Medical Analysis Systems, Inc. | 1994 | — |
| −4 | K983807 | Lyphochek Tumor Marker Control, Model #580 | Bio-Rad | 1998 | — |
| −3 | K992172 | Lyphochek Tumor Marker Control, Model 580 | Bio-Rad | 1999 | — |
| −2 | K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580 | Bio-Rad | 2001 | — |
| −1 | K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak | Bio-Rad Laboratories | 2008 | — |
| 0 (this device) | K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20 | Fujirebio Diagnostics,Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 JJY? 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? (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 |
|---|---|---|---|
| * | K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakSummary page 1…21 CFR 862.1660 Regulatory Class: Class I, reserved Product Code: JJY Predicate Device Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036) For HE4: ARCHITECT HE4 Control Kit (K093957) Summary and Principle This quality control product can be used as an objective jud… | 2008 |
| * | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…Summary page 1…Class I, reserved Product Code: JJY Predicate Device Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036) For HE4: ARCHITECT HE4 Control Kit (K093957) Summary and Principle This quality control product can be used as an objective judgment of the laboratory's procedures and pers… | 2010 |
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 16 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101809 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101809: Fujirebio Diagnostics Tumor Marker Control Model 108-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101809
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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