510(k) · Cleared
ClearedLiquichek Tumor Marker Control
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 Jul 3, 2007 as substantially equivalent to K011579 (Bio-Rad, 2001) after a 14-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 3, 2007
- Review
- 14 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940433 (1994). 2 later devices descend from it, 2 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 deviceK071675 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007
- Descendant · cites it directly · 0 of its ownK163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
- Descendant · cites it directly · 0 of its ownK141073 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K071675 | Liquichek Tumor Marker Control | Bio-Rad Laboratories | 2007 | — |
| +1 | K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level… | Bio-Rad Laboratories | 2017 | — |
| +1 | K141073 | Liquichek Tumor Marker Control | Bio-Rad Laboratories | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 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…ently in the market: Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618 51 0 (k) Number: K011 579 A copy of the product insert for the above product can be found in Appendix 7. 02-510(k) Liq Tumor Markers-547 07… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K163015 (Bio-Rad Laboratories, 2017) 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. 2007, 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?
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071675: Liquichek Tumor Marker Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071675
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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