510(k) Report

FDA applicant

Bionostics, Inc.

Devens, MA49 decisions1983–20133 recalls

FDA records 49 decisions for Bionostics, Inc. (Devens, MA) from 1983 to 2013: 49 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 43 predicates, 17 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Bionostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2013

2008: 32009: 12010: 12011: 32012: 12013: 3
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bionostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)22decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)10decisions
  • JJSControls For Blood-Gases, (Assayed And Unassayed)5decisions
  • JJRElectrolyte Controls (Assayed And Unassayed)2decisions
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2decisions
  • KRZCalibrator For Hemoglobin And Hematocrit Measurement1decision

Also: DIF (1), JIS (1), LCH (1), JGS (1), GLK (1), OSL (1).

Whose devices does it build on?

Its devices cite 43 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 17 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K880447Multi-Function Blood Gas ControlBionostics, Inc. · 19884cite it
  • K032453Roche Combitrol and Autotrol Plus B Multi Analyte ControlBionostics, Inc. · 20034cite it
  • K012430Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc. · 20014cite it
  • K022769Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 20023cite it
  • K955630Rna Medical Hemat ControlBionostics, Inc. · 19963cite it
  • K002540Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip SystemsBionostics, Inc. · 20002cite it

What has FDA decided for it lately?

  • 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
  • K112356Glucose Meter-Check Control Solution for Agamatrix WavesenseBionostics, Inc. · 2011
  • K103553Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionBionostics, Inc. · 2011
  • K101831Enterix Insurefit Fob Controls, Model 16800Bionostics, Inc. · 2010

All 49 as Bionostics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K972868Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mLJan 9, 2024Class II
  • K972868Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mLJan 9, 2024Class II
  • K013147FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott…Feb 17, 2006