510(k) · Cleared
ClearedLiquichek CK/LD Isoenzyme Control; Levels 1 and 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Aug 23, 1990 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 23, 1990
- Review
- 23 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
- Descendant · cites it directly · 8 of its ownK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
- Descendant · 2 generations on · 2 of its ownK021384 Liquichek Urine Toxicology Control Levels C1-C4, Models…Bio-Rad · 2002
- Descendant · 2 generations on · 2 of its ownK012999 Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001
- Descendant · 2 generations on · 1 of its ownK050037 Triage Tox Drug Screen ControlsBiosite Incorporated · 2005
- Descendant · 3 generations on · 1 of its ownK033404 Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad · 2003
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K981590Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…Bio-Rad · 1998 · cites it directly8descendants
- K021384Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444Bio-Rad · 2002 · 2 generations on2descendants
- K012999Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001 · 2 generations on2descendants
- K050037Triage Tox Drug Screen ControlsBiosite Incorporated · 2005 · 2 generations on1descendant
- K033404Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad · 2003 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903430 | Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 | Bio-Rad | 1990 | — |
| +1 | K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology… | Bio-Rad | 1998 | — |
| +2 | K021384 | Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444 | Bio-Rad | 2002 | — |
| +2 | K012999 | Triage Tox Drug Screen Controls, Catalog #94001 | Biosite Incorporated | 2001 | — |
| +2 | K050037 | Triage Tox Drug Screen Controls | Biosite Incorporated | 2005 | — |
| +3 | K033404 | Liquichek Urine Toxicology Control (Confirmatory Series) | Bio-Rad | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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 JJT? 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? (11)
See all 112 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?
- Of its descendants, K981590 (Bio-Rad, 1998) has gone furthest, with 8 descendants of its own.
How does its category compare?
All JJT devicesJJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJT
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JJT
Too few JJT 510(k)s in any year since 2007 to give a median.
Recalls per year · JJT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJT
1in 2011
MAUDE reports naming product code JJT, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K903430 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903430: Liquichek CK/LD Isoenzyme Control; Levels 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903430
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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