510(k) Report

FDA applicant

Home Diagnostics, Inc.

Fort Lauderdale, FL22 decisions1985–20097 recalls

FDA records 22 decisions for Home Diagnostics, Inc. (Fort Lauderdale, FL) from 1985 to 2009: 22 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). 7 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 Home Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 22009: 1
2007high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

4in 2016

2013: 32016: 4
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Home Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter10decisions
  • CGAGlucose Oxidase, Glucose9decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2decisions
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K080641Trueresult Blood Glucose System E4H01-81Home Diagnostics, Inc. · 20083cite it
  • K030703Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test StripsHome Diagnostics, Inc. · 20032cite it
  • K042080Trackease Smart System Blood Glucose SystemHome Diagnostics, Inc. · 20041cites it
  • K070593Trackrecord Data Management SoftwareHome Diagnostics, Inc. · 20071cites it

What has FDA decided for it lately?

  • K090495Truebalance Blood Glucose SystemHome Diagnostics, Inc. · 20092 recalls
  • K080641Trueresult Blood Glucose System E4H01-81Home Diagnostics, Inc. · 20081 recall
  • K080710TRUE2GO Blood Glucose System, Model F4H01-81Home Diagnostics, Inc. · 20081 recall
  • K070593Trackrecord Data Management SoftwareHome Diagnostics, Inc. · 2007
  • K060793Element Blood Glucose Test SystemHome Diagnostics, Inc. · 2006
  • K051147Sidekick Blood Glucose Test SystemHome Diagnostics, Inc. · 2005
  • K042080Trackease Smart System Blood Glucose SystemHome Diagnostics, Inc. · 20041 recall
  • K040670Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose ControlHome Diagnostics, Inc. · 2004

All 22 as Home Diagnostics, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K042080TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Jun 28, 2016Class II
  • K090495TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Jun 28, 2016Class II
  • K030703TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Jun 28, 2016Class II
  • K080641TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Jun 28, 2016Class II
  • K090495MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for…Oct 2, 2013Class II
  • K032657MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for…Oct 2, 2013Class II