510(k) · Cleared
ClearedLiquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek Pediatric Control, Bilevel Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 6, 2013 as substantially equivalent to K872227 (Bio-Rad, 1987) after a 28-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 6, 2013
- Review
- 28 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872227 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872227 Liquichek Pediatric Control Levels I and IIBio-Rad · 1987
- This deviceK130963 Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol…Bio-Rad Laboratories, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872227 | Liquichek Pediatric Control Levels I and II | Bio-Rad | 1987 | — |
| 0 (this device) | K130963 | Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2… | Bio-Rad Laboratories, Inc. | 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 |
|---|---|---|---|
| * | K872227 | Liquichek Pediatric Control Levels I and IISummary page 1…ice to Which Substantial Equivalence is Claimed Liquichek Pediatric Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K872227 4.0 Description of Device Liquichek Pediatric Control is prepared from bovine serum with added chemicals,… | 1987 |
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?
- Its one ancestor has no 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 Pediatric Control is intended for use as a quality control serum to monitor
the precision of laboratory testing procedures for the analytes listed in this package
insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130963 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130963: Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek Pediatric Control, Bilevel Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130963
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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