510(k) · Cleared
ClearedAssure Platinum and Glucocard Vital Blood Glucose Monitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray Factory USA, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Oct 23, 2009 as substantially equivalent to K063068 (Arkray USA, Inc., 2006) after a 190-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Oct 23, 2009
- Review
- 190 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063068 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK063068 Ferrara Blood Glucose Monitoring System, Model 631100Arkray USA, Inc. · 2006
- This deviceK091102 Assure Platinum and Glucocard Vital Blood Glucose Monitoring SystemsArkray Factory USA, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063068 | Ferrara Blood Glucose Monitoring System, Model 631100 | Arkray USA, Inc. | 2006 | — |
| 0 (this device) | K091102 | Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems | Arkray Factory USA, Inc. | 2009 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063068 | Ferrara Blood Glucose Monitoring System, Model 631100Summary page 1…Classification: Glucose test system, 21 CFR 862.1345 and 862.1660; Class 11 Product Codes: CGA, NBW, JJX Predicate Device: Ferrara Meter (K063068) Device Description: The GLUCOCARD® VitalTm Blood Glucose Monitoring System consist of a meter,… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K063068.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 GLUCOCARD® VitalTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The GLUCOCARD®…
Read the full statement (283 words)
The GLUCOCARD® VitalTM Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and
palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home
(over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare
professionals, as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD® VitalTM Blood Glucose Monitoring System is not intended for the diagnosis
of or screening for diabetes mellitus, and is not intended for use on neonates.
The GLUCOCARD® VitalTM Blood Glucose Meter is intended for the quantitative measurement of
glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is
done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter
[OTC]) by persons.with diabetes, or in clinical settings by healthcare professionals, as an aid to
monitor the effectiveness of diabetes control.
GLUCOCARD® VitaI TM test strips are intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertips and palms when used with the
GLUCOCARD® VitalTM Blood Glucose Meter. Testing is done outside the body (In Vitro
diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with
diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness
of diabetes control.
For use with GLUCOCARD® VitalTM Blood Glucose Meter and GLUCOCARD® VitalTM Blood
Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Control solutions are available in two levels - Level 1 (Normal) and Level 2 (High).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091102: Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091102
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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