Services
Test Category
Comparative clinical study of invasive blood gas analysis
The laboratory carries out accuracy validation studies of standard blood oxygen according to the approval document of the ethics committee of Shenzhen University General Hospital. The test range is 70% - 100%, comparing to the blood gas analyzer.
Comparative referenced study of non-invasive Spo2 analysis
Most often used to fine-tune the accuracy of tested oximeters in the engineering, research and development stage, to compare results against a standard reference oximeter and adjust built-in parameters of the test product.
Specific Functional Study
Provide clinical assistance for specific functions of tested oximeters according to customer requirements, such as anti movement interference, weak perfusion, infant mock, CO hemoglobin and other special tests.
Cost Determination Factors
The lab charges standard amounts for standard clinical tests. For charging evaluation of non-standard requirements of customers, a comprehensive evaluation will be conducted according to the nature of the test, the number and race of volunteers to be recruited, the duration of the tests, etc.
Determination Factors for Non-invasive Comparative Standard Referenced Clinical Test:
- Standard Referenced Oximeters: Nellcor, Masimo, Nonin
- Standard 5 volunteers (including 1 dark-skin & 1 light-skin)
- Request for additional volunteers
- Request for specific volunteer groups
- Data recording methods
- Request for lab assistance in the absence of client
- Non-working day or holiday work request
- Other requests
Determination Factors for Invasive Comparative Standard Clinical Test:
- Standard Equipment: ABL90 Blood Gas Analyzer
- Standard 12 volunteers (including 2-3 dark-skins & 2-3 light-skins)
- Request for additional volunteers
- Request for specific volunteer groups
- Data recording methods
- Request for lab assistance in the absence of client
- Non-working day or holiday work request
- Request for additional data analysis report
Specific Functional Studies:
- Assessment based on specific test contents and protocol
Call Me
Address
Block A5, Unit 204, So Fun Land, Taoyuan Community, Nanshan District, Shenzhen
Contact Details
Phone：0755-86170552
Ms. Huang：13556869952
Mr. Cai：13528442155
Laboratory Services
Test Pre-booking
Our test protocols are designed to meet related regulations and conditions of US FDA, CE and NMPA. Test protocols will be approved by SUGH GCP Office and Ethical Committee (IRB) for Medical Devices.
Kindly contact our lab research coordinator to pre-book test dates.
- Phone: 0755-86170552
- Ms.Huang: 13556869952
- Mr.Cai : 13528442155
Note: Please book early in view of strict work procedures.
- Please book test dates early due to complicated administrative document submission and lab work arrangements.
- Please obtain application materials from lab coordinator. Study the standard test protocol to determine if the tested products meet test requirements.
- Sponsors should submit all product information and related application documents to the Ethical Committee of SUGH for approval. All clinical tests can be carried out upon the approval of the Committee.
- A Chief Physician from SUGH must be appointed as the Investigator of the test for product registration. The investigator shall assess all parameters of the product and organize clinical examination work.
