510(k) · Cleared

Cleared

Fdi Glucose Control Solution for Use with Accu-Chek Aviva

K123612510(k) TraditionalCleared Jan 17, 201355-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

Fujirebio Diagnostics,Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jan 17, 2013 as substantially equivalent to K043474 (Roche Diagnostics Corp., 2005) after a 55-day review. Its family tree reaches back 2 generations to 2001.

Decided: Jan 17, 2013
Review: 55 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010362 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
1 generation backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
This deviceK123612 Fdi Glucose Control Solution for Use with Accu-Chek AvivaFujirebio Diagnostics,Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010362	Accu-Chek Comfort Curve Test Strip	Roche Diagnostics Corp.	2001	6
−1	K043474	Accu-Chek Aviva System	Roche Diagnostics Corp.	2005	10
0 (this device)	K123612	Fdi Glucose Control Solution for Use with Accu-Chek Aviva	Fujirebio Diagnostics,Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K123612, 2001–2013Source: 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
*	K043474	Accu-Chek Aviva System Summary page 1 …ACGU-OHEK Aviva Control Level 1 Manufacturer: Roche Diagnostics 510(k) No.: k043474 Device Description: The FDI Glucose Control Solution for Aviva consists of a viscosit…	Roche Diagnostics Corp.	2005	10

Also cleared against K043474: 9 other devices →

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 12 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
2 of the 3 ancestors have a recall of any class.
9 other devices also cite its predicate K043474.

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 FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123612: Fdi Glucose Control Solution for Use with Accu-Chek Aviva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123612

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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