510(k) · Cleared
Recalled · 2010Nova Statstrip Xpress Glucose Hospital Meter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · CGA Glucose Oxidase, Glucose
Cleared on Jul 11, 2007 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jul 11, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- 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 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?
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2010 | Not classified | Z-1783-2010 | Nonconforming Material/Component | Glucose strips report low glucose results |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Nova StatStrip Glucose Test Strips are intended for use only with Nova…
Read the full statement (215 words)
The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.
Nova StatStrip Glucose Test Strips are intended for use only with Nova StatStrip Glucose Hospital Meters for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).
Nova StatStrip Control Solutions is intended for use with Nova StatStrip Glucose Hospital Meters and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter.
Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of Nova StatStrip Glucose Hospital Meter Systems. There are five levels of linearity solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070960: Nova Statstrip Xpress Glucose Hospital Meter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070960
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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