510(k) Report

510(k) · Cleared

Cleared

Autosure Voice II Blood Glucose Monitoring System and Test Strips

K102037510(k) SpecialCleared Aug 13, 201025-day reviewClass II21 CFR 862.1345

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

Apex BioTechnology Corp. · CGA Glucose Oxidase, Glucose

Cleared on Aug 13, 2010 after a 25-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided
Aug 13, 2010
Review
25 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2022: 2 descendants cleared2015: 1 descendant cleared2011: 1 descendant cleared2012: 3 descendants cleared2014: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2010201520202025
  1. This deviceK102037 Autosure Voice II Blood Glucose Monitoring System and Test StripsApex BioTechnology Corp. · 2010
  2. Descendant · cites it directly · 5 of its ownK113098 Autosure Voice II Plus, Autosure Plus Blood Glucose Test…Apex BioTechnology Corp. · 2012
  3. Descendant · 2 generations on · 3 of its ownK131750 Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014
  4. Descendant · 3 generations on · 2 of its ownK161299 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose…Apex BioTechnology Corp. · 2016
  5. Descendant · cites it directly · 2 of its ownK110571 Telcare Blood Glucose Monitoring System, Test Strips, Control…Telcare, Inc. · 2011 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK120064 Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32014: 22015: 12016: 12018: 12022: 2
2011high 3 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K113098Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus IiiApex BioTechnology Corp. · 2012 · cites it directly5descendants
  • K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014 · 2 generations on3descendants
  • K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2016 · 3 generations on2descendants
  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc. · 2011 · cites it directly2descendants
  • K120064Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K102037Autosure Voice II Blood Glucose Monitoring System and Test StripsApex BioTechnology Corp.2010—
+1K113098Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus IiiApex BioTechnology Corp.2012—
+2K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.2014—
+3K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring…Apex BioTechnology Corp.2016—
+1K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions…Telcare, Inc.20111
+2K120064Test, Blood Glucose SystemHmd Biomedical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201420
201510
201610
201810
202220
FIG. 1 — Lineage of K102037, 2010–2022Source: 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 CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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
*—AutoSure Voice meter and test strips
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K113098Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus IiiApex BioTechnology Corp.20125
K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc.20112
K212140GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220
K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose…Apex BioTechnology Corp.20150

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K113098 (Apex BioTechnology Corp., 2012) has gone furthest, with 5 descendants of its own.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

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

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (in Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to…

Read the full statement (169 words)

The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (in Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Indications for use as stated in the FDA summary.

More from Apex BioTechnology Corp.

35 FDA decisions under this applicant name. See the company

  • K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp. · 2025
  • K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K212140GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2022

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https://510kreport.com/device/K102037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102037: Autosure Voice II Blood Glucose Monitoring System and 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/K102037

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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