510(k) · Cleared
ClearedLiquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2, Liquichek Spinal Fluid Control Minipak
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 Jan 31, 2013 as substantially equivalent to K990888 (Bio-Rad, 1999) after a 52-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 31, 2013
- Review
- 52 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932076 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK932076 Liquichek Spinal Fluid Control Levels I and IIBio-Rad · 1993
- 1 generation backK990888 Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Bio-Rad · 1999
- This deviceK123775 Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid…Bio-Rad Laboratories · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932076 | Liquichek Spinal Fluid Control Levels I and II | Bio-Rad | 1993 | — |
| −1 | K990888 | Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752 | Bio-Rad | 1999 | — |
| 0 (this device) | K123775 | Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level… | Bio-Rad Laboratories | 2013 | — |
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 |
|---|---|---|---|
| * | K990888 | Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752Summary page 1…Which Substantial Equivalence is Claimed Liquichek Spinal Fluid Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K990888 4.0 Description of Device Liquichek Spinal Fluid Control Is a human based control with added constituents of… | 1999 |
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 20 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- None of the 2 ancestors has a recall.
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. 2013, 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 Spinal Fluid Control is intended for use as an assayed quality control
material to monitor the precision of laboratory testing procedures for the analytes
listed in this package insert.
The following analytes are listed in the package insert:
> Albumin
> Chloride
> Glucose
> Immunoglobulin G (IgO)
> Lactate (Lactic Acid)
> Lactate Dehydrogenase (LDH)
> Protein Total
> Sodium
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123775 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123775: Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2, Liquichek Spinal Fluid Control Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123775
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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