510(k) Report

510(k) · Cleared

Cleared

Glucosure Star Blood Glucose Monitoring System, Model AS90000E1

K073648510(k) TraditionalCleared Apr 10, 2008106-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 Apr 10, 2008 as substantially equivalent to K062799 (Apex BioTechnology Corp., 2007) after a 106-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it.

Decided
Apr 10, 2008
Review
106 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K011233 (2001). 13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2022: 3 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant clearedK011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalledK062799 · Gluco Track Blood Glucose Monitoring System · Apex BioTechnology Corp. · 2007200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K062799 · Gluco Track Blood Glucose Monitoring System · Apex BioTechnology Corp. · 2007K011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalled0+5
  1. Root · 2 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
  2. 1 generation backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
  3. This deviceK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
  4. Descendant · cites it directly · 12 of its ownK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
  5. Descendant · 2 generations on · 9 of its ownK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
  6. Descendant · 3 generations on · 3 of its ownK141036 BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015
  7. Descendant · 3 generations on · 3 of its ownK131750 Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014
  8. Descendant · 4 generations on · 2 of its ownK170267 BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22014: 12015: 22016: 12017: 12018: 12021: 12022: 3
2011high 3 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all
  • K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011 · cites it directly12descendants
  • K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012 · 2 generations on9descendants
  • K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · 3 generations on3descendants
  • K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014 · 3 generations on3descendants
  • K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2017 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011233Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp.20011
−1K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.2007—
0 (this device)K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp.2008—
+1K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.2011—
+2K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.2012—
+3K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.2015—
+3K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.2014—
+4K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201410
201520
201610
201710
201810
202110
202230
FIG. 1 — Lineage of K073648, 2001–2022Source: 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 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
Get a 510(k) Report

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
*K062799Gluco Track Blood Glucose Monitoring System
Summary page 1
…stem Classification: Glucose test system, 21 CFR 862.1345, Class II Product Codes: CGA, NBW, JJX Predicate Device: GlucoTrack Blood Glucose Monitoring System (k062799) Device GlucoSure Star consists of a meter, test strips, and control Description: solutions for use in measur…
Apex BioTechnology Corp.2007—

Also cleared against K062799: 2 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.201112

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?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.7 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K102816 (Apex BioTechnology Corp., 2011) has gone furthest, with 12 descendants of its own.
  • 2 other devices also cite its predicate K062799.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

GlucoSure Star Blood Glucose Monitoring System: The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. It is indicated for both lay use by people with diabetes and in a clinical setting by…

Read the full statement (118 words)

GlucoSure Star Blood Glucose Monitoring System:

The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. 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.

GlucoSure Star Test Strips:

The GlucoSure Star Blood Glucose Test Strips are to be used with the GlucoSure Star Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Indications for use as stated in the FDA summary.

Also cleared against K062799

2 other devices cite the same predicate.

  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use…Telcare, Inc. · 20111 recall
  • K073137Glucosure Voice Blood Glucose Monitoring System, Model AS90011E1Apex BioTechnology Corp. · 2008

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

Recent decisions in CGA

The CGA category page

  • K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K073648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073648: Glucosure Star Blood Glucose Monitoring System, Model AS90000E1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073648

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