510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Trackease Smart System Blood Glucose System

K042080510(k) SpecialCleared Aug 19, 200416-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

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

Cleared on Aug 19, 2004 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.

Decided
Aug 19, 2004
Review
16 days
Class
Class I
Product code
JJX
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared200020052010201520202025
  1. This deviceK042080 Trackease Smart System Blood Glucose SystemHome Diagnostics, Inc. · 2004
  2. Descendant · cites it directly · 0 of its ownK070649 SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • 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)K042080Trackease Smart System Blood Glucose SystemHome Diagnostics, Inc.2004—
+1K070649SMS Glucose Control, Model 2120061Spectrum Medical Supply, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K042080, 2004–2007Source: 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 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 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?

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

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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-2882-2016Nonconforming Material/ComponentProduct gives incorrect low blood glucose levels.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070649 (Spectrum Medical Supply, Inc., 2007) has gone furthest, with 0 descendants of its own.

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?

The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. 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

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The JJX category page

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https://510kreport.com/device/K042080 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042080: Trackease Smart System Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042080

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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