510(k) Report

510(k) · Cleared

Recalled · 2006

Glucose Control Solution for Therasense Freestyle

K013147510(k) TraditionalCleared Oct 24, 200134-day reviewClass I21 CFR 862.1660Recalls 1

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 Oct 24, 2001 as substantially equivalent to K012430 (Bionostics, Inc., 2001) and 1 other predicate after a 34-day review. Its family tree reaches back 2 generations to 1993. It has been recalled once.

Decided
Oct 24, 2001
Review
34 days
Class
Class I
Product code
JJX
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K925479 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestorsK925479 · Sugar Chex Linearity for the One Touch · Streck Laboratories, Inc. · 1993K012430 · Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 · Bionostics, Inc. · 20011990199219941996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K012430 · Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 · Bionostics, Inc. · 2001K925479 · Sugar Chex Linearity for the One Touch · Streck Laboratories, Inc. · 19930
  1. Root · 2 generations backK925479 Sugar Chex Linearity for the One TouchStreck Laboratories, Inc. · 1993
  2. 1 generation backK012430 Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc. · 2001
  3. This deviceK013147 Glucose Control Solution for Therasense FreestyleBionostics, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K925479Sugar Chex Linearity for the One TouchStreck Laboratories, Inc.1993—
−1K012430Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc.2001—
0 (this device)K013147Glucose Control Solution for Therasense FreestyleBionostics, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
FIG. 1 — Lineage of K013147, 1993–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012430Multi-Meter Glucose Calibration Verification Material, Model Rna GL3
Summary page 1
…Multi-Meter Glucose Glucose Control Sclution | Glucose Control Solution Calibration Verification for LifeScan FastTake for TheraSense FreeStyle Material 510(k), Date: | K012430, 08/27/01 K000318, 02/28/00 Number of levels: | 5 1 3 Analytes: | Glucase Glucose Glucose Container: | plastic bottle plastic bot…
Bionostics, Inc.2001—
*K000318Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood…
Summary page 1
…se Glucose Control Sclution | Glucose Control Solution Calibration Verification for LifeScan FastTake for TheraSense FreeStyle Material 510(k), Date: | K012430, 08/27/01 K000318, 02/28/00 Number of levels: | 5 1 3 Analytes: | Glucase Glucose Glucose Container: | plastic bottle plastic bottle plastic battle…
Bionostics, Inc.2000—

Also cleared against K012430: 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)

Recalls of this device

DateClassRecallRoot causeReason
Feb 17, 2006Not classifiedZ-0605-06OtherThe device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
  • None of the 4 ancestors has a recall.
  • 3 other devices also cite its predicate K012430.

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.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
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

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

Glucose Control Solution for TheraSense FreeStyle Blood Glucose Monitoring System is

intended for use to verify the performance of the FreeStyle BGM System at multiple glucose

levels within the reportable range. The Glucose Control Solution 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.

Also cleared against K012430

3 other devices cite the same predicate.

  • K032819Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test SystemBionostics, Inc. · 2003
  • K021624Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4Bionostics, Inc. · 2002
  • K021697Glucose Control Solution for BD LatitudeBionostics, Inc. · 2002

More from Bionostics, Inc.

49 FDA decisions under this applicant name. See the company

  • K131136Glucose Meter-Check Solution for TaidocBionostics, Inc. · 2013
  • K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
  • K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
  • K113764Glucose Meter-Check Solution for InfopiaBionostics, Inc. · 2012
  • K112352Glucose Meter-Check Control for Nipro TrueresultBionostics, Inc. · 2011

Recent decisions in JJX

The JJX category page

  • K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K013147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013147: Glucose Control Solution for Therasense Freestyle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013147

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026