510(k) · Cleared
ClearedGlucolab Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Aug 2, 2005 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Aug 2, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942455 (1995). 5 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- 1 generation backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- This deviceK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK091157 Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK113192 Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK132862 Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK091168 Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK090712 Eocene SystemInfopia Co, Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009 · cites it directly2descendants
- K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012 · 2 generations on1descendant
- K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013 · 3 generations on0descendants
- K091168Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd. · 2010 · cites it directly0descendants
- K090712Eocene SystemInfopia Co, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −1 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| 0 (this device) | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| +1 | K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | 2009 | — |
| +2 | K113192 | Healthpro Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +3 | K132862 | Healthpro Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | 2013 | — |
| +1 | K091168 | Glucophone Blood Glucose Test System, Model Igm-0025 | Infopia Co, Ltd. | 2010 | — |
| +1 | K090712 | Eocene System | Infopia Co, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsSummary page 2…onclusion: The GLUCOLABTM Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diag… | 2003 |
| * | K984261 | Surestep Blood Glucose Monitoring SystemSummary page 2…tem is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential… | 1999 |
| * | K021513 | Accu-Chek Advantage ModuleSummary page 2…the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential Page 123… | 2002 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K091157 (Infopia Co, Ltd., 2009) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K024194.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GLUCOLAB TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites. The GLUCOLAB TM System provides plasma-equivalent results. The GLUCOLABTM System is not intended to be used with neonatal blood samples. The GLUCOLABTM System is for…
Read the full statement (153 words)
The GLUCOLAB TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites. The GLUCOLAB TM System provides plasma-equivalent results. The GLUCOLABTM System is not intended to be used with neonatal blood samples. The GLUCOLABTM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GlucoLab control is used with GlucoLabTM Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results. Control Solutions are sold separately
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051285: Glucolab Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051285
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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