中文品名：羅氏可霸斯生化快速監測系統
英文品名： cobas b 101 System
醫材字號：衛部醫器輸字第026530號
效能：
申請商名稱：台灣羅氏醫療診斷設備股份有限公司
申請商地址：台北市中山區民權東路3段2號10樓
製造廠名稱：PHC Corporation In Vitro Diagnostics Division Wakimachi Plant
製造廠廠址：110 Oaza-Inoshiri-aza-Nishiueno, Wakimachi, Mima, Tokushima, 779-3603, Japan

更多內容

cobas b 101 system

One-stop solution for HbA1c, lipids, and CRP testing in the Primary Care Setting

The cobas b 101 system is an IVD test system offering HbA1c, lipid panel and CRP tests at the Point of Care. Fresh capillary blood, K2 or K3-EDTA or lithium heparin anticoagulated venous whole blood can be used for HbA1c. Fresh capillary blood, K2 or K3-EDTA anticoagulated whole blood or plasma can be used for lipids (CHOL, TRIGL, HDL-CHOL, LDL, non-HDL). Fresh capillary blood or serum, K2 or K3-EDTA or lithium heparin anticoagulated whole blood or plasma can be used for CRP. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory or at Point of Care locations.

Guideline compliant performance

cobas b 101 system complies with all relevant standards and methods (IFCC, DCCT/NGSP)¹

Easy and safe operation

Direct blood application from a single finger stick with small volume
No calibration needed, maintenance and service-free, guidance by the graphical user interface (GUI)

Fast turnaround time

From patient preparation to displaying dual testing results in a less than 15-minute workflow and single testing results in about 6 minutes (CRP in less than 4 minutes)
A choice of single HbA1c, lipid panel and CRP testing or dual HbA1c and lipid panel tests

System characteristics

User-friendly with a large touchscreen, full keyboard, and multiple language support
Robust, maintenance- and calibration-free with a wide operating temperature and humidity range
Connection to cobas^® infinity POC IT solutions
External printer or barcode scanner allow an improved workflow and documentation
Data download to USB stick and then to a PC or data download to IT solutions installed on PC.

Disc Features

Direct sample application from finger (no capillaries, tubes or pipettes are needed)
Requires only very small sample volumes (2 μL for HbA1c, 19 μL for lipids and 12 μL for CRP)
Discs are color-coded and clearly labelled to support correct use.
Hinge cover concept for operator safety
Discs can be stored for more than 16 months at room temperature (2-30 ºC)^2,3,4

Overview

The cobas b 101 is an in vitro diagnostic instrument for the quantitative evaluation of clinical chemistry assays and immunoassays using the cobas b 101 test discs. The cobas b 101 instrument is intended for near-patient testing. Not for self-testing.

Regulatory Disclaimer

For in vitro diagnostic use.

Product specifications

Sample size

HbA1c: 2 μL
Lipid: 19 μL
CRP: 12 μL

Sample material

HbA1c: Capillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)
HbA1c PST: Capillary whole blood
Lipids: Capillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)
Lipid PST: Capillary whole blood
CRP: Capillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin)

Measurement range

HbA1c: 20-130 mmol/mol (IFCC) or 4-14 % (DCCT/NGSP)
Lipid: CHOL: 50-500 mg/dL or 1.28-12.95 mmol/L
TRIGL: 45-650 mg/dL or 0.50-7.35 mmol/L
HDL-CHOL: 15-100 mg/dL or 0.38-2.60 mmol/L
LDL-CHOL: estimated using the Friedewald equation
CRP: 3.0-400 mg/L or 0.30-40.0 mg/dL

Test storage

2-30 °C

Test stability

Unopened: CRP Lipid: 16 months
HbA1c: 22 months
Opened: 20 minutes

衛部醫器輸字第026530號

Roche cobas b101 System 羅氏可霸斯生化快速監測系統