Stat Profile
Stat Profile pHOx Ultra/CCX Capillary Tube 115 uL with Na Heparin 250 per Vial
8manufacturers in China registered for this device type
17catalogue 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) | K023567 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
| Packaging | Box, carton |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PHOX PLUS L | 3 | In distribution | |
| ULTRA/CCX | In distribution | ||
| PLUS/PLUS C | 3 | In distribution | |
| CCX/PHOX/BASIC/PLUS/L/C | In distribution | ||
| Prime ABG/CCS | In distribution | ||
| PRIME CCS COMP | In distribution | ||
| PHOX PLUS | In distribution | ||
| PHOX ULTRA CO OX | In distribution | ||
| CCX | In distribution | ||
| pHOx Ultra/CCX | In distribution | ||
| ULTRA/CCX | 3 | In distribution | |
| PHOX/BASIC/PLUS/L/C | In distribution | ||
| pHOx Ultra/CCX | 250 | In distribution | |
| CCX | In distribution | ||
| PLUS/L/C | In distribution | ||
| CCX CO-OX | In distribution | ||
| Prime Plus | 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 |
| 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 |
| 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | 510(k) number | 2017-06-19 | Class II | Software design | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. | 179 units (US) and 904 (OUS) Total 1083 | 2018-08-14 |
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.