510(k) · Cleared
ClearedRandox CSF Controls Levels 2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 23, 2013 as substantially equivalent to K040280 (Roche Diagnostics Corp., 2004) after a 104-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 23, 2013
- Review
- 104 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871027 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- 2 generations backK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- 1 generation backK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- This deviceK132156 Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| −2 | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K132156 | Randox CSF Controls Levels 2 and 3 | Randox Laboratories, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR ControlsSummary page 2…CE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Roche PreciControl PUC (Proteins in Urine/CSF) norm and PreciControl PUC path 510 (k)Number: k040280 5. INTENDED USE The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control… | 2004 |
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 26 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K040280.
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?
The Randox CSF Controls Levels 2 and 3 are intended for in vitro diagnostic use as
assayed quality control material to monitor the precision of diagnostic methods using
CSF as a sample on clinical chemistry systems.
This in vitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132156: Randox CSF Controls Levels 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132156
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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