510(k) · Cleared
ClearedLiquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel 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 Jan 10, 2017 as substantially equivalent to K071675 (Bio-Rad Laboratories, 2007) after a 74-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jan 10, 2017
- Review
- 74 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940433 (1994). 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 backK071675 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007
- This deviceK163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
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 | K071675 | Liquichek Tumor Marker Control | Bio-Rad Laboratories | 2007 | — |
| 0 (this device) | K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level… | Bio-Rad Laboratories | 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 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 |
|---|---|---|---|
| * | K071675 | Liquichek Tumor Marker ControlSummary page 4…660 3.0 Device to Which Substantial Equivalence is Claimed Liquichek Tumor Marker Control Bio-Rad Laboratories Predicate 510(k) Number: K071675 4.0 Description of Device Liquichek Tumor Marker Control is prepared from human source material with added… | 2007 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K071675.
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. 2017, 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 Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163015: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163015
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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