510(k) · Cleared
ClearedDiatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip; Diatrue Glucose Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delbio Incorporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 13, 2012 after a 487-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 13, 2012
- Review
- 487 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
DiaTrue Plus Blood Glucose Monitoring System: The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes…
Read the full statement (288 words)
DiaTrue Plus Blood Glucose Monitoring System:
The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates.
DiaTrue Plus Blood Glucose Meter:
The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.
DiaTrue Plus Blood Glucose Test Strips:
The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They ate indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.
DiaTrue Glucose Control solution:
For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level 1, Level 11 and Level 1I1.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103329: Diatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip; Diatrue Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103329
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026