510(k) · Cleared
Recalled · Class II · 2013Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on May 7, 2007 after a 119-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- May 7, 2007
- Review
- 119 days
- Class
- Class II
- Product code
- CGL
- Recalls
- 5
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK070068 Nova Statsensor Creatinine Hospital Meter, Control…Nova Biomedical Corp. · 2007
- Descendant · cites it directly · 2 of its ownK171059 Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK261039 i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251281 Nova Max Creat eGFR Monitoring SystemNova Biomedical Corporation · 2026
Most influential descendants
Showing 3 of 3 · See all- K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation · 2017 · cites it directly2descendants
- K261039i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2026 · 2 generations on0descendants
- K251281Nova Max Creat eGFR Monitoring SystemNova Biomedical Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity… | Nova Biomedical Corp. | 2007 | — |
| +1 | K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017 | — |
| +2 | K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2026 | — |
| +2 | K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2026 | 2 | 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.
Planning a device in CGL? 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 CGL device
- #1 K261039 i-STAT Crea cartridge with the i-STAT 1 Systemscore 11.9 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | 2017 | 2 |
Has anything in its family been recalled? (0 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 21, 2008 | Not classified | Z-1472-2008 | Component design/selection | Lithium batteries may fail if the glucose or creatinine meters have been dropped. |
| Nov 2, 2007 | Not classified | Z-0725-2008 | Device Design | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
| Nov 2, 2007 | Not classified | Z-0726-2008 | Device Design | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
| Nov 2, 2007 | Not classified | Z-0724-2008 | Device Design | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171059 (Nova Biomedical Corporation, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGL devicesCGL Electrode, Ion Based, Enzymatic, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGL
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CGL
Too few CGL 510(k)s in any year since 2007 to give a median.
Recalls per year · CGL
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGL
8in 2025
MAUDE reports naming product code CGL, 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 | 1 | — | 3 | 17 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates. Nova StatSensor Creatinine Test Strips are intended for use only with the…
Read the full statement (217 words)
The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.
Nova StatSensor Creatinine Test Strips are intended for use only with the StatSensor Creatinine Hospital Meter for quantitative tests. The Nova StatSensor Creatinine Hospital Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatSensor Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only).
Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine 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 StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine 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/K070068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070068: Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070068
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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