510(k) · Cleared
ClearedLyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 8, 2008 as substantially equivalent to K011579 (Bio-Rad, 2001) after a 53-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Sep 8, 2008
- Review
- 53 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940433 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK940433 Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 1994
- 3 generations backK983807 Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998
- 2 generations backK992172 Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999
- 1 generation backK011579 Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001
- This deviceK082036 Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008
- Descendant · cites it directly · 0 of its ownK101809 Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940433 | Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 | Medical Analysis Systems, Inc. | 1994 | — |
| −3 | K983807 | Lyphochek Tumor Marker Control, Model #580 | Bio-Rad | 1998 | — |
| −2 | K992172 | Lyphochek Tumor Marker Control, Model 580 | Bio-Rad | 1999 | — |
| −1 | K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580 | Bio-Rad | 2001 | — |
| 0 (this device) | K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak | Bio-Rad Laboratories | 2008 | — |
| +1 | K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20 | Fujirebio Diagnostics,Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Summary page 1…is currently in the market: Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 92618 510(k) Number: K011579 A copy of the product insert for the above product can be found in Appendix 7. 02-51 (k)Lyp Tumor MarkersPlus_367… | 2001 |
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 |
|---|---|---|---|
| K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20 | 2010 | 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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101809 (Fujirebio Diagnostics,Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K011579.
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. 2008, 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?
Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Domestic Analytes Listed
* Adrenocorticotropic Hormone (ACTH)
* Alpha Fetoprotein (AFP)
* Aldosterone
Beta-2-Microglobulin (B2M)
* CA 15-3
* CA 19-9
* CA 27.29
* CA 125
* Calcitonin
* Carcinoembryonic Antigen (CEA)
* Ferritin
* hCG Beta Subunit (P-hCG)/ hCG
· Prostatic Acid Phosphatase (PAP)
* Prolactin
· Prostate Specific Antigen, Total ( PSA)
* Prostate Specific Antigen, Free (Free PSA)
· Thyroglobulin (Tg)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082036: Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082036
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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