Model note · Glucometer
Nova StatStrip Glucose Hospital Meter System
StatStrip is a hospital point of care glucose meter with a touchscreen, bar code scanner, optional Wi-Fi and a rechargeable lithium battery, docked in a charging and data station at the nurses' station. It is cleared for capillary, venous, arterial and neonatal samples across all hospital settings, including capillary testing in critically ill patients, which is unusual for meters. Results flow to the hospital data management system and LIS.
The model
Maker, model and type.
- Maker
- Nova Biomedical Corporation
- Model
- StatStrip Glucose Hospital Meter System
- Device type
- Glucometer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| System contents | Meter with optional integrated Wi-Fi, charging station, StatStrip test strips, 3.7 V lithium battery, quick reference guide, IFU and log book; QC (3 levels) and linearity (5 levels) solutions sold separately | Source |
| Strip chemistry | Glucose enzyme (over 1.0 IU) with ferricyanide mediator; blood drawn into the strip by capillary action | Source |
| Specimens | Capillary finger stick, venous, arterial, neonatal arterial and neonatal heel stick whole blood; not neonatal cord blood | Source |
| Battery and sleep | Rechargeable battery gives about 8 hours of use; meter sleeps after 90 seconds idle | Source |
| Wireless | IEEE 802.11 a/b/g Wi-Fi as an optional route for results | Source |
| Critical care capillary accuracy (prospective study, 568 patients) | At 75 mg/dL or above: 91.0% within 15% and 96.8% within 20% of plasma reference | Source |
| FDA clearance | K181043 (July 2018, critical care capillary indication and CLIA waiver), predicate K150281; product code PZI, Class II, 21 CFR 862.1345 | Source |
Recalls
Known FDA recalls.
- Z-3128-20262026-07-29
Bar code timing fault may keep the previous patient or QC ID on screen, linking a result to the wrong record (also Z-3129 to Z-3132 for other models).
FDA record - Z-0681-20252024-11-20
Gen 2 firmware bug could transmit wrong results to the data management system over Wi-Fi; fixed by software v0.0.13.45 or later.
FDA record - Z-0650-20142013-10-10
Revised battery removal and expiry instructions after swelling and cell leakage.
FDA record - Z-1783-20102010-02-12
StatStrip glucose strips (cat. 42214) reporting low results.
FDA record - Z-1472-20082008-02-21
Lithium polymer batteries could fail after the meter was dropped; replaced on site.
FDA record
Safety
Safety warnings from the record.
- A result can be stored against the previous patient if a stale bar code stays on screen and the operator accepts it. Source
- With the old Gen 2 firmware, opening Review Results during a Wi-Fi transmission could send a wrong high or low value to the record. Source
- Swollen batteries can force the battery door open and stop the meter working. Source
- Not for diabetes screening or diagnosis, and not for cord blood. Source
Sources
Where this note comes from.
- FDA 510(k) K181043 summary, StatStrip Glucose Hospital Meter System
- openFDA recall search, StatStrip
- openFDA MAUDE problem counts, StatStrip brand
Not covered: The hospital meter IFU (with its Meter Screen Alerts table) and Nova's documents were not reachable, so there are no on screen alert codes, measuring range, haematocrit range, environmental limits or cleaning agents; a public training deck found was for the separate StatStrip Xpress and was not used. Recall records were read through openFDA.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Glucometer