510(k) · Cleared
ClearedQuest Diagnostics Serum Chemistry Control, Models 935 and 945
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 Dec 2, 2003 as substantially equivalent to K011867 (Bio-Rad, 2001) after a 40-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Dec 2, 2003
- Review
- 40 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923633 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- 1 generation backK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- This deviceK033387 Quest Diagnostics Serum Chemistry Control, Models 935 and 945Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK073080 Quest Diagnostics Serum Chemistry Control, Models 935 and 945Bio-Rad Laboratories · 2008
Most influential descendants
Showing 1 of 1 · See all- K073080Quest Diagnostics Serum Chemistry Control, Models 935 and 945Bio-Rad Laboratories · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| −1 | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| 0 (this device) | K033387 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945 | Bio-Rad | 2003 | — |
| +1 | K073080 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945 | Bio-Rad Laboratories | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800Summary page 1…Which Substantial Equivalence is Claimed Bio-Rad Laboratories Liquid Assayed Multiqual Control Irvine, California Docket Number: K01 1867 4.0 Description of Device Quest Diagnostics Serum Chemistry Control is prepared from human serum to which… | 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 |
|---|---|---|---|
| K073080 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945 | 2008 | 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 11 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K073080 (Bio-Rad Laboratories, 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K011867.
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?
For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033387: Quest Diagnostics Serum Chemistry Control, Models 935 and 945.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033387
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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