510(k) · Cleared
ClearedStatStrip Xpress 2 Glucose Hospital Meter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Cleared on Jan 27, 2016 as substantially equivalent to K150461 (Nova Biomedical Corporation, 2015) after a 110-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Jan 27, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- PZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060345 (2006). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006 · Recalled
- 2 generations backK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- 1 generation backK150461 StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015
- This deviceK152986 StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2016
- Descendant · cites it directly · 0 of its ownK163490 StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corp. | 2006 | 3 |
| −2 | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| −1 | K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2015 | — |
| 0 (this device) | K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2016 | — |
| +1 | K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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 PZI? 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 PZI device
- #1 K252323 cobas pulse blood glucose monitoring systemscore 12.4 · 4 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 |
|---|---|---|---|
| * | K150461 | StatStrip Xpress Glucose Hospital Meter SystemSummary page 4…gulatory Panel: Clinical Chemistry Regulatory Number: 21CFR 862.1345 Device Class: II Product Code: CGA, Glucose Oxidase, Glucose Predicate Device: K150461-StatStrip Xpress Glucose Hospital Meter System Device Description: The StatStrip Xpress Glucose Hospital Meter System previousl… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | 2017 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K163490 (Nova Biomedical Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150461.
How does its category compare?
All PZI devicesPZI Prescription Use Blood Glucose Meter For Near-Patient Testing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PZI
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PZI
816in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PZI
5so far in 2026, the most since 2007
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · PZI
35in 2025
MAUDE reports naming product code PZI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 87 | 0 | 0 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 3 | 816 | 1 (1) | 5 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 1 | — | 5 (5) | — |
What is it indicated for?
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial…
Read the full statement (135 words)
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152986: StatStrip Xpress 2 Glucose Hospital Meter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152986
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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