Nova Primary
Nova Primary is a laboratory system that measures glucose in lithium heparinized venous whole blood or plasma. The analyzer draws a 25 microliter sample from a syringe, blood collection…
Nova Primary is a laboratory system that measures glucose in lithium heparinized venous whole blood or plasma. The analyzer draws a 25 microliter sample from a syringe, blood collection tube, microcentrifuge tube or sample cup.
Its replaceable sensor and membrane assembly use glucose oxidase to generate hydrogen peroxide from the sample. An electrode measures the resulting electrical current, which is proportional to glucose concentration. Results are reported as plasma equivalent glucose values.
Listed Item
Nova Primary Calibrator Cartridge 150 Sample
System Components and Readout
The system combines the analyzer, glucose sensor, membrane and calibrator cartridge, with an optional barcode scanner. For whole blood samples, an impedance based conductivity detector automatically adjusts the measurement to produce the plasma equivalent result. A color touchscreen provides the interface, and an onboard thermal printer produces a paper readout.
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203549 |
| Record published | 2023-02-09 |
| Record revised | 2026-04-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Nova Primary Calibrator Cartridge 150 Sample | In distribution | ||
| Nova Primary Ampuled Control 1, 2 | 20 | In distribution | |
| Nova Primary Calibrator Cartridge 450 Sample | In distribution | ||
| Nova Primary Glucose Membrane | 3 | In distribution | |
| Nova Primary Analyzer | In distribution | ||
| Nova Primary Linearity Level 1 | 10 | In distribution | |
| Nova Primary Linearity Level 2 | 10 | In distribution | |
| Nova Primary Glucose Sensor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i-STAT | Abbott Point OF Care Inc. | 48 |
| YSI Incorporated | YSI Incorporated | 34 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 28 |
| Stat Profile | Nova Biomedical Corporation | 17 |
| Fora | Fora Care Inc. | 13 |
| TRUEtrack | Trividia Health, Inc. | 12 |
| JAS Diagnostics | Drew Scientific, Ltd. | 11 |
| StatStrip | Nova Biomedical Corporation | 9 |
| Gluc-PAP | Randox Laboratories Limited | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Prodigy No Coding Blood Glucose Test Strips | Prodigy Diabetes Care, LLC | 7 |
| StatSensor/StatStrip | Nova Biomedical Corporation | 6 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203549 | 2022-10-18 |
| K200349 | 2020-03-13 |
| K180340 | 2018-09-26 |
| K070960 | 2007-07-11 |
| K063821 | 2007-01-24 |
| K060345 | 2006-04-28 |
| K924743 | 1992-11-06 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-10-10 | Class II | Component design/selection | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage | est. 200,000 | 2014-03-24 |
| 2013-02-25 | Class II | Process design | Glucose test strips reports no result message when tested | 7433 cases | 2014-09-26 |
| 2013-02-25 | Class II | Process design | Glucose test strips reports no result message when tested | 2200 cases | 2014-09-26 |
| 2010-02-12 | Not classified | Nonconforming Material/Component | Glucose strips report low glucose results | 392 Cases (1800 strips each) | 2011-07-22 |
| 2008-02-21 | Not classified | Component design/selection | Lithium batteries may fail if the glucose or creatinine meters have been dropped. | 4432 batteries | 2008-10-28 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990026 | 2002-02-04 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.