510(k) · Cleared

Cleared

Aldolase Controls Level 2, and Aldolase Control Level 3

K131776510(k) TraditionalCleared Jul 18, 201331-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Randox Laboratories, Ltd. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jul 18, 2013 as substantially equivalent to K000875 (Bio-Rad, 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000.

Decided: Jul 18, 2013
Review: 31 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000875 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK000875 Assayed QCS 1,2, Cat. Nos. 970200, 970500Bio-Rad · 2000
This deviceK131776 Aldolase Controls Level 2, and Aldolase Control Level 3Randox Laboratories, Ltd. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000875	Assayed QCS 1,2, Cat. Nos. 970200, 970500	Bio-Rad	2000	—
0 (this device)	K131776	Aldolase Controls Level 2, and Aldolase Control Level 3	Randox Laboratories, Ltd.	2013	—

FIG. 1 — Lineage of K131776, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJX? 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

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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	Applicant	Decided	Recalls
*	K000875	Assayed QCS 1,2, Cat. Nos. 970200, 970500 Summary page 1 …hemistry Product Code: JJX 21 CFR Number: 21 CFR 862.1660 4. PREDICATE DEVICE PROPRIETARY NAME AND 510(k) NUMBER BIO0-RAD QCS Assayed Control 510(k) Number: k000875 5. INTENDED USE The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as…	Bio-Rad	2000	—

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 JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The Randox Aldolase Controls Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of Aldolase on the clinical chemistry analysers indicated in the package insert. This device is for prescription use only.

This in vitro diagnostic device is intended for prescription use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131776 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131776: Aldolase Controls Level 2, and Aldolase Control Level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131776

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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