510(k) · Cleared
ClearedQuantimetrix Human Bilirubin Control I & II Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantimetrix Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 23, 1986 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- May 23, 1986
- Review
- 72 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK860942 Quantimetrix Human Bilirubin Control I & II LiquidQuantimetrix Corp. · 1986
- Descendant · cites it directly · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 3 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 4 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
- Descendant · 2 generations on · 2 of its ownK160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride…Instrumentation Laboratory CO · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · cites it directly12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · 2 generations on11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 3 generations on10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 4 generations on2descendants
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860942 | Quantimetrix Human Bilirubin Control I & II Liquid | Quantimetrix Corp. | 1986 | — |
| +1 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| +2 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +3 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +4 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
| +2 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized… | Instrumentation Laboratory CO | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition… | 2010 | 12 |
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?
- Of its descendants, K093623 (Instrumentation Laboratory CO, 2010) has gone furthest, with 12 descendants of its own.
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 | — |
https://510kreport.com/device/K860942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K860942: Quantimetrix Human Bilirubin Control I & II Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860942
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026