510(k) · Cleared

Cleared

Glucose Meter-Check Control Solution for Agamatrix Wavesense

K112356510(k) TraditionalCleared Sep 19, 201134-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

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

Cleared on Sep 19, 2011 as substantially equivalent to K052762 (Agamatrix, Inc., 2006) after a 34-day review. Its family tree reaches back 1 generation to 2006.

Decided: Sep 19, 2011
Review: 34 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052762 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK052762 Liberty Blood Glucose Monitoring System, Model 8000-0067Agamatrix, Inc. · 2006
This deviceK112356 Glucose Meter-Check Control Solution for Agamatrix WavesenseBionostics, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052762	Liberty Blood Glucose Monitoring System, Model 8000-0067	Agamatrix, Inc.	2006	—
0 (this device)	K112356	Glucose Meter-Check Control Solution for Agamatrix Wavesense	Bionostics, Inc.	2011	—

FIG. 1 — Lineage of K112356, 2006–2011Source: 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
*	K052762	Liberty Blood Glucose Monitoring System, Model 8000-0067 Summary page 1 …Glucose Meter-Check Control Solution for AgaMatrix 510(k), Date: K052762, Jan 23 2006 Number of levels: 2, typical fasting glucose and 1, typical fasting glucose…	Agamatrix, Inc.	2006	—

Also cleared against K052762: 3 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?

Its one ancestor has no recall.
3 other devices also cite its predicate K052762.

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. 2011, 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 Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K112356 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112356: Glucose Meter-Check Control Solution for Agamatrix Wavesense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112356

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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