510(k) · Cleared
ClearedQuest Tumor Marker Control, Model 955
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 5, 2004 as substantially equivalent to K011579 (Bio-Rad, 2001) after a 24-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Nov 5, 2004
- Review
- 24 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940433 (1994). No later device cites it as a predicate yet.
- 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 deviceK042815 Quest Tumor Marker Control, Model 955Bio-Rad · 2004
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) | K042815 | Quest Tumor Marker Control, Model 955 | Bio-Rad | 2004 | — |
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…ch Substantial Equivalence is Claimed Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K011579 4.0 Description of Device This product is prepared from human serum with added chemicals, constituents of huma… | 2001 |
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 10 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- 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.
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?
Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum 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/K042815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042815: Quest Tumor Marker Control, Model 955.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042815
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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