Siemens DCA Vantage Analyzer Placement Program
Rally #P138-1-0023Siemens #4DCAPLACE3
Diabetes Management Analyzer DCA Vantage® CLIA Waived
PROMOTIONAL PKG, DCA VANTAGE BUNDLE 4KT W/36MO WARRANTY (1/KT)
Placement Program Details
Rally # | P138-1-0023 |
Manufacturer # | 4DCAPLACE3 |
Brand | DCA Vantage® |
Manufacturer | Siemens |
Country of Origin | Unknown |
Contents 1 | DCA Vantage Analyzer, (4) DCA HbA1c Reagent Kits, (1) DCA HbA1c Control Kit, 36 Month Warranty |
Purchase Program Type | Placement Promotion Bundle |
DCA Vantage Analyzer Product Information
DCA HbA1c Reagent Kits Product Information
DCA HbA1c Control Kit Product Information
DCA Vantage Analyzer
The DCA Vantage® Analyzer is a multi-parameter, point-of-care analyzer for monitoring glycemic control in patients with diabetes and detecting early kidney disease.Features
- CLIA-waived HbA1c test that is IFCC and NGSP-certified
- 1µl finger stick without fasting – HbA1c results in 6 minutes
- Random urine sample provides A:C ratio in 7 minutes
- Requires no sample or reagent preparation prior to testing
- Plug and play installation
- Simple, one-step calibration scan with every new lot
- Guided user-interface with step-by-step testing instructions
- Hassle-free maintenance
- QC lockout prevents patient testing if QC not tested or fails
- Prevent unauthorized users from testing and accessing confidential patient information
- Eliminate transcription errors with bar-code data entry and automatic transmission of results
- Link patient results to operators and material lot information (audit-ready)
- Customizable operator-specific system access mode
- Robust reagent cartridges designed to minimize pre-analytical errors associated with sample and reagent handling
Product Specifications Overview (DCA Vantage® Analyzer)
Manufacturer # | 10282969 |
Brand | DCA Vantage® |
Manufacturer | Siemens |
Country of Origin | United Kingdom |
Alternate Manufacturer Number | 5075US |
Analyzer Type | Benchtop, Point-of-care immunoassay analyzer |
Application | Diabetes Management Analyzer |
CLIA Classification | CLIA Waived (HbA1c) |
CLIA Classified | CLIA Waived |
UNSPSC Code | 41115819 |
Quantitative Tests: | Hemoglobin A1c (whole blood): Range: 2.5% to 14% (4mmol/mol to 130 mmol/mol) Microalbumin/Creatinine (urine): Single test reports all three results for: 1) Albumin: 5 to 300 mg/L; 2) Creatinine: 15 to 500 mg/dL (1.3 to 44.2 mmol/L); 3) Albumin-to Creatinine Ratio: 1 to 2000 mg/g (0.11 to 226 mg/mmol) |
Test Format: | Self-contained immunoassay cartridges |
Test Measurement: | Automatic, optional transmission |
Test Method: | HbA1c: monoclonal antibody agglutination reaction Albumin: polyclonal goat anti-human albumin antiserum Creatinine:Benedict Behre chemical reaction |
Time to Test Results | HbA1c - 6 minutes, A:C Ratio - 7 minutes |
Sample Volume | HbA1c - 1µL whole blood Microalbumin/Creatinine - 40µL urine |
Sample Preparation | No pretreatment; no pipetting required |
Sample ID/Operator ID Entry | Optional; via touch screen or bar code reader |
Calibration | 1) Lot-specific calibration card provides automatic calibration with every cartridge 2) Traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods for measurement of HbA1c |
Storage Capacity/Memory | 4000 patient and/or control records, Up to 1,000 operator IDs |
Display | Color touch screen with 1/4 VGA resolution |
Data Export | Via USB flash drive to PC or direct to LIS/HIS or data manager, if interfaced |
Quality Control/Compliance (DCA Vantage® Analyzer)
Flexible QC Scheduling | None, Automatic Reminders or Required |
QC Testing | Optional lockout if schedule not followed or QC fails |
User/Operator Access | Restricted, if desired, to protect patient and QC data and prevent unauthorized use |
Matching Lab Results/Reference Method | Adjustable correlation to reference methods |
Reference Ranges | User-definable reference ranges available for HbA1c |
Computer/Peripheral Interfaces (DCA Vantage® Analyzer)
Serial Port | RS232, ASTM |
Ethernet Connection | ASTM or POCT1-A2 |
Bi-Directional Capabilities | ASTM: Remote computer can be set up to lock out patient tests POCT1-A2: Remote computer can be set up to lock out patient tests, and send operator list to analyzer |
USB-Port | Standard USB 2.0 |
External Bar Code Reader (optional) | Serial (9 pin) |
Onboard Printer | 54 mm (2 in) width, thermal/label stock |
External Printer | Supports standard PCL printer interface via USB port |
General (DCA Vantage® Analyzer)
Dimensions | 9.0 H x 11.5 W x 10.5 D [Inches] (25.4 H x 28.7 W x 27.7 D [cm]) |
Weight | 3.88 kg (9.0 lb) |
Power Requirements | 100 to 240 VAC; 50/60 Hz |
Line Leakage Current | <0.3 mA in normal condition, <0.5 mA in single fault condition |
Maximum Power Input | 70 VA; 30 watts |
Ambient Operating Temperature | 15°C to 32°C (59°F to 89.6°F) - Hemoglobin A1c 18°C to 30°C (64.4°F to 86°F) (HbA1c) - Microalbumin/Creatinine |
Operating Temperature | 5°C to 40°C (41°F to 104°F), 15% to 90% relative humidity |
Safety | TUV SUD with CB Scheme, CSA-C22.2, EN60601, IEC 60601, UL60601 |
EMC Emissions/Immunity | FCC 47: Part 15 (Class B), EN60601-1-2 (Class B) |
DCA HbA1c Reagent Kits
Rally #138-1-1610Siemens #10311134
HbA1c Test Kit DCA™ Systems CLIA Waived
REAGENT KIT, DCA VANTAGE A1C (10/BX) (40/CS)
Features
- CLIA-waived HbA1c test results in 6 minutes with just a 1 μL whole-blood fingerstick sample.
- Quantitative HbA1c* testing results in minutes.
- Increases patient comfort by requiring a smaller whole-blood sample (1 μL).
- Add sample to test cartridge, load, and walk away.
- No sample or reagent preparation required.
Product Specifications
Rally # | 138-1-1610 |
Manufacturer # | 10311134 |
Brand | DCA™ Systems |
Manufacturer | Siemens |
Country of Origin | United States |
Alternate Manufacturer Number | 5035C |
Application | HbA1c Test Kit |
CLIA Classification | CLIA Waived |
CLIA Classified | CLIA Waived |
Contents 1 | (10) Reagent Cartridges, (11) Capillary Holders, (2) Package Inserts, Calibration Card |
For Use With | For DCA 2000, DCA Vantage Analyzers |
Reading Type | Machine Read |
Sample Type | Whole Blood Sample |
Specialty | Immunoassay |
Storage Requirements | Requires Refrigeration |
Test Format | Cartridge Format |
Test Kit Type | Rapid |
Test Method | Latex Immunoagglutination Inhibition Methodology |
Test Name | HbA1c Test |
Test Type | Diabetes Management |
Time to Results | 6 Minute Results |
UNSPSC Code | 41116104 |
WARNING: Reproductive Harm -www.P65Warnings.ca.gov
DCA HbA1c Control Kit
Rally #138-1-1630Siemens #10311161
Diabetes Management Test Control Set DCA Hemoglobin A1c (HbA1c) Normal / Abnormal 4 X 0.25 mL
CONTROL, A1C F/DCA VANTAGE ANALYZER (4/KT)
Features
- Acceptable for use with RA® / opeRA HbA1c Reagent Kit, ADVIA® Chemistry Systems HbA1c Reagent Kit and the ADVIA IMS® HbA1c Reagent Kit
- 2 NORMAL Controls (0.25 mL when reconstituted)
- 2 ABNORMAL Controls (0.25 mL when reconstituted)
- 1 Reconstitution Fluid (2.0 mL)
- 4 Eyedropper Cap Assemblies
- 2 Package Inserts and 1 DCA 2000 Normal and Abnormal Control Card
Product Specifications
Rally # | 138-1-1630 |
Manufacturer # | 10311161 |
Brand | DCA 2000 |
Manufacturer | Siemens |
Country of Origin | United States |
Alternate Manufacturer Number | 5068A |
Application | Control Set |
For Use With | DCA 2000 and DCA Vantage Analyzers |
Levels | Normal / Abnormal |
Storage Requirements | Requires Refrigeration |
Test Category | Diabetes |
Test Name | Hemoglobin A1c (HbA1c) |
Test Type | Diabetes Management Test |
UNSPSC Code | 41116212 |
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DCA Vantage Analyzer Documentations
- DCA Vantage Host Computer Communications Link - Rev E
- DCA Unpacking Guide Self Test - Diabetes - Rev A
- DCA Vantage - Instructions for Software Download from Document Library
- DCA Vantage Analyzer - Declarations of Conformity
- DCA Vantage Analyzer Self Test Unpacking Guide- EN/ IT
- DCA Vantage Analyzer Self-Test - Declarations of Conformity
- DCA Vantage Operator's Guide
- DCA Vantage Quick Reference Guide - Rev C
- DCA Vantage Self Test IFU - Diabetes - Rev A
- DCA Vantage Self Test Operator's Guide
- DCA Vantage Software Upgrade V4.6 Release Notes
- DCA Vantage Software V4.7 - Upgrade Instructions
- DCA Vantage Software Versions 4.0-4.x Release Notes - English - Rev D
HBA1C Reagent Kit and Controls Documentations
- Addendum to Instructions For Use - Hemoglobin A1c - Rev C
- DCA Hba1c Control Kit - Rev H - IFU/Package Insert Multilingual
- DCA Hemolglobin A1c IFU Self Test Use - Diabetes - Rev A
- DCA System HbA1c Normal and Abnormal Control Kit - Rev G - IFU/Package Insert
- DCA Systems HBA1C - USA - Rev A - IFU/Package Insert
- DCA Systems HbA1c Controls - Declarations of Conformity
- DCA Systems HBA1C Self-Test IFU - Rev A
- DCA Vantage HbA1c Quick Reference Guide
- DCA Vantage HbA1c Self-Test - Declarations of Conformity
- HbA1c IFU - DCA - Rev A
- DCA Systems Reagents and Capillary Holders - Declarations of Conformity
- A1c testing belongs in your office
- Leverage In-office POC HbA1c & uACR Testing
- Handling Hemoglobin A1c Samples
- Analyzing Hemoglobin A1c Samples
- Performing Hemoglobin A1c Quality Control
- Scanning a Hemoglobin A1c Calibration Card
- Testing HbA1c and Microalbumin/ Creatinine
- Recalling Hemoglobin A1c Calibration Data