510(k) · Cleared
Recalled · Class II · 2013Nova Statstrip 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 Jan 24, 2007 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 24, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 4
- Predicates
- 0
13 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- This deviceK063821 Nova Statstrip Glucose Hospital Meter SystemNova Biomedical Corp. · 2007
- Descendant · cites it directly · 12 of its ownK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- Descendant · cites it directly · 5 of its ownK150281 StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015
- Descendant · 2 generations on · 4 of its ownK181043 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK150461 StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK200788 Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232075 StatStrip Glucose Hospital Meter System3 generations on · 2024
Most influential descendants
Showing 5 of 13 · See all- K132121Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014 · cites it directly12descendants
- K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015 · cites it directly5descendants
- K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018 · 2 generations on4descendants
- K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015 · 2 generations on3descendants
- K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063821 | Nova Statstrip Glucose Hospital Meter System | Nova Biomedical Corp. | 2007 | — |
| +1 | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| +1 | K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015 | — |
| +2 | K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
| +2 | K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2015 | — |
| +2 | K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 1 |
| 2026 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2013 | Class II | Z-0650-2014 | Component design/selection | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage |
| Feb 25, 2013 | Class II | Z-1153-2013 | Process design | Glucose test strips reports no result message when tested |
| Feb 25, 2013 | Class II | Z-1154-2013 | Process design | Glucose test strips reports no result message when tested |
| Feb 12, 2010 | Not classified | Z-1783-2010 | Nonconforming Material/Component | Glucose strips report low glucose results |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K132121 (Nova Biomedical Corporation, 2014) has gone furthest, with 12 descendants of its own.
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 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 the…
Read the full statement (216 words)
The Nova StatStrip 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 the StatStrip Glucose Hospital Meter 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 the Nova StatStrip Glucose Hospital Meter 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 the Nova StatStrip Glucose Hospital Meter System. 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/K063821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063821: Nova Statstrip 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/K063821
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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