510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips

K030703510(k) TraditionalCleared Jul 11, 2003127-day reviewClass II21 CFR 862.1345Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Home Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jul 11, 2003 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 2 times.

Decided
Jul 11, 2003
Review
127 days
Class
Class II
Product code
NBW
Recalls
2
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK030703 Truetrack Smart System Blood Glucose Meter and True Track Smart…Home Diagnostics, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK092645 Fdi Glucose Control Levels 1, 2 and 3Fujirebio Diagnostics,Inc. · 2009
  3. Descendant · cites it directly · 0 of its ownK070649 SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K092645Fdi Glucose Control Levels 1, 2 and 3Fujirebio Diagnostics,Inc. · 2009 · cites it directly0descendants
  • K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030703Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood…Home Diagnostics, Inc.2003—
+1K092645Fdi Glucose Control Levels 1, 2 and 3Fujirebio Diagnostics,Inc.2009—
+1K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
FIG. 1 — Lineage of K030703, 2003–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NBW device

  1. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092645Fdi Glucose Control Levels 1, 2 and 3Fujirebio Diagnostics,Inc.20090
K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 28, 2016Class IIZ-2881-2016Nonconforming Material/ComponentProduct gives incorrect low blood glucose levels.
Feb 25, 2013Class IIZ-1140-2013Environmental controlMeter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092645 (Fujirebio Diagnostics,Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

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

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, 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
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Indications for use as stated in the FDA 510(k) statement.

More from Home Diagnostics, Inc.

22 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K030703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030703: Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030703

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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