510(k) · Cleared
ClearedLiquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control Level 2 Model 272, Liquichek Etha
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 Nov 20, 2012 as substantially equivalent to K955024 (Bio-Rad, 1995) after a 40-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Nov 20, 2012
- Review
- 40 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955024 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955024 Liquichek Ethanol/Ammonia ControlBio-Rad · 1995
- This deviceK123198 Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek…Bio-Rad Laboratories · 2012
- Descendant · cites it directly · 0 of its ownK140393 Randox Ammonia Ethanol Control Levels 1, 2 and Level 3Randox Laboratories Limited · 2014
Most influential descendants
Showing 1 of 1 · See all- K140393Randox Ammonia Ethanol Control Levels 1, 2 and Level 3Randox Laboratories Limited · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955024 | Liquichek Ethanol/Ammonia Control | Bio-Rad | 1995 | — |
| 0 (this device) | K123198 | Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia… | Bio-Rad Laboratories | 2012 | — |
| +1 | K140393 | Randox Ammonia Ethanol Control Levels 1, 2 and Level 3 | Randox Laboratories Limited | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K955024 | Liquichek Ethanol/Ammonia ControlSummary page 1…evice Name: Liquichek Ethanol/Ammonia Control Applicant: Bio-Rad Laboratories 510(k) Number: K955024 Product Code: JJY Regulation #: 862.1660 Device Classifica… | 1995 |
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 |
|---|---|---|---|
| K140393 | Randox Ammonia Ethanol Control Levels 1, 2 and Level 3 | 2014 | 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?
- Its one ancestor has no recall.
- Of its descendants, K140393 (Randox Laboratories Limited, 2014) has gone furthest, with 0 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. 2012, 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 Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are included in the package insert:
1. Ethanol
2. Ammonia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123198: Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control Level 2 Model 272, Liquichek Etha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123198
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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