StatStrip
StatStrip Xpress2 GLU Meter with Battery and Quick Reference Guide
8manufacturers in China registered for this device type
9catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls on this code
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) | K152986 |
| Record published | 2016-09-20 |
| Record revised | 2019-08-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 40 °C; Special storage condition: 0 ft to 15000 ft; Storage environment temperature 15 to 40 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Carton, carton of 2, carton of 18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1.0 | In distribution | ||
| 1.0 | In distribution | ||
| 1.0 | In distribution | ||
| Xpress2 | In distribution | ||
| Xpress | In distribution | ||
| Lancet | 100 | In distribution | |
| 1.0 | In distribution | ||
| GLU Test Strip | 50 | In distribution | |
| Statstrip | 50 | 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 |
| Gluc-PAP | Randox Laboratories Limited | 8 |
| Nova Primary | Nova Biomedical Corporation | 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.