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Product Data Sheet 32 The healthcare industry is undergoing significant changes and a key example is the consolidation of clinical laboratories. The consolidation of existing laboratories into one is creating a crucial need for high volume and convenient analyzers. Working with an analyzer that reduces operating costs while increasing convenience is a must to succeed in this changing environment. Product The MedTest Dx BA-800M Automated Clinical Analyzer is a versatile, high-volume platform with a built-in Sample Delivery Module (SDM). The SDM is capable of handling up to 440 sample positions and automatically delivers samples to the analytical unit by means Regulatory and Certification • 510(k) Cleared Market: High Volume Clinical Laboratory Testing MedTest Dx BA-800M High Throughput Automated Clinical Analyzer: Increasing operator walk-away time and overall laboratory efficiency Figure 1: 800.445.9853 (International) +1.734.487.8300 www.medtestdx.com of color coded sample racks, which are shown in Figure 1. The BA-800M can deliver throughputs of 800 tests/ hr. without ISE and 1200 tests/ hr. with ISE. The system is capable of running Drugs of Abuse screening reagents, general chemistries and ISE’s. This innovative analyzer is equipped with conventional software and an intuitive user interface with a sleek design, making it the ideal solution for today’s fast-paced laboratory environments. 1. Control Rack 2. Calibrator Rack 3. Manual Return Rack 4. STAT Sample Rack 5. Routine Sample Rack 1 2 3 4 5

Features Advantages Product Data Sheet 32 …...Features, Advantages, and Bene˜ts DS-H7546-01 06/18 Features Patented antibody with high specificity for HbA1c Fully Automated Direct

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Features, Advantages, and Bene�ts

DS-H7546-01 06/18

Features

Patented antibody with high specificity for HbA1c

Fully Automated

Direct measurement of HbA1c

Does not require a standalone system

NGSP Certification & Traceable to IFCC Standard

Advantages

Minimizes cross-reactivity from hemoglobin variant molecules

No offline sample pretreatment

Does not require additional channel for determination of

total hemoglobin

Eliminates the need for HbA1c specific analyzers

Standardized tests results to test methods used in clinical studies

Benefits

More precise results » no interference from hemoglobin variants / adducts; Carbamylated Hb, Acetylated Hb, HbA2, HbS, HbC, HbE and HbD

Streamline testing process with more accurate results and less

hands-on activities

Saves space on analyzer and cost of running additional test

Save laboratory space and money by the consolidation of clinical

laboratory equipment

Increase patient confidence by a NGSP certified test

Ordering Information

Product Number Analyzer Speci�c Description

H7546-40 Open Channel R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

REAGENTS

H7541-CALCALIBRATORS

H7546-120 Open Channel R1: 1 x 90 mL, R2: 1 x 30 mL

OH546-40 Beckman AU R1: 2 x 15 mL, R2: 1 x 10 mL

HBA-480 BS-480 R1: 2 x 60 mL, R2: 2 x 20 mL

HBA-600 BS-200 R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

12-H7546-40 BS-200(International)

R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

H7541-CTLCONTROLS

Lyophilized

Lyophilized

1 vial each of 4 levels

2 vials each of 2 levels

Instrument Applications

• Abbot Aeroset• Alycon• ATAC 8000 • Beckman/Olympus AU400, AU640, AU2700, AU5400, CX, DxC, LX • Bayer Advia 1650, 1800, 2400• Biolis 24i• Biotecnica BT2000/3000• Chemwell• Cobas 6000, c501, Mira, Mira Plus• Envoy 500• Express• Dimension

• Hitachi - 704, 717, 747, 902, 911, 912, 914, 917• Konelab 20, 30, 60• Mindray - BS-200, BS-300, BS-400, BS-480, BA-800M • Pentra 400• Pointe 360• Prestige 24i• RA - 500, 1000• Randox Daytona• Selectra SE• Sirrus• Spectrum• Targa • Vitros 5

Product Data Sheet 32

The healthcare industry is undergoing significant changes and a key example is the consolidation of clinical laboratories. The consolidation of existing laboratories into one is creating a crucial need for high volume and convenient analyzers. Working with an analyzer that reduces operating costs while increasing convenience is a must to succeed in this changing environment.

Product

The MedTest Dx BA-800M Automated Clinical Analyzer is a versatile, high-volume platform with a built-in Sample Delivery Module (SDM). The SDM is capable of handling up to 440 sample positions and automatically delivers samples to the analytical unit by means

Regulatory and Certification

• 510(k) Cleared

Market: High Volume Clinical Laboratory Testing

MedTest Dx BA-800M High Throughput Automated Clinical Analyzer: Increasing operator walk-away time and overall laboratory efficiency

Figure 1:

800.445.9853(International) +1.734.487.8300 www.medtestdx.com

of color coded sample racks, which are shown in Figure 1. The BA-800M can deliver throughputs of 800 tests/ hr. without ISE and 1200 tests/ hr. with ISE. The system is capable of running Drugs of Abuse screening reagents, general chemistries and ISE’s. This innovative analyzer is equipped with conventional software and an intuitive user interface with a sleek design, making it the ideal solution for today’s fast-paced laboratory environments.

1. Control Rack2. Calibrator Rack3. Manual Return Rack4. STAT Sample Rack5. Routine Sample Rack

12

34

5

Features, Advantages, and Benefits

DS-M1114-01.2

Features

MTBF 3 years

800 photometric tests / hour without ISE

1200 photometric test / hour with ISE

Largest Sample Delivery Module (SDM) among the same class of

analyzers

100 uL minimum reaction volume

R1 ~ R4 Reagent Format

Advantages

A robust system that is manufactured with high quality

components

A high performance and through-put clinical system

Capable of processing up to a total of 440 samples at a time

Less reagent consumed per test

Increase capability of running different assays, e.g. Vitamin D

Benefits

Get the highest percent ROI on your purchase

Quicker turn-around-time for test results, dramatically shortening the

waiting time for lab results

Longer walk-away time, frees up operators’ time to perform other

tasks

Lowers the cost per tests, allowing for higher financial returns

Eliminates the need for standalone specialty testing analyzers

Built-in carryover protection

Intuitive software with built-in  operation commands

Lessen reagent cross reactivity

Logical, easy to navigate software

Highly reliable patient results

Save time and money in operator training

Product Number

80-BA800M

80-BA800M-ISE

115-022798-00

Description

BA-800M Analyzer without ISE, 220V, Barcode Reader, Glass Cuvettes, Drainage

Tubing BA-800M ISE Module (Optional)

DI Water Supply Module (Optional)

ORDERING INFORMATION

Product Data Sheet 23

As shown in figure 1, diabetes on a global basis is increasing at an exponential rate. To diagnose and monitor diabetes it is necessary to evaluate patient’s glucose and HbA1c levels. Glucose levels reflect an individual’s glycemia at a specific point in time, whereas HbA1c levels reflect the average glucose levels over the previous 2-3 months. Therefore, HbA1c has been recommended for the diagnosis of diabetes.

Product

The Pointe Scientific two-part HbA1c assay is a stabilized modification of the previous, innovative HbA1c three-part reagent that was first introduced in 2003. The improved reagent maintains the same antibodies and buffers but includes additional stabilizers in the R2 to allow it to become a single component as opposed to two separate components that required mixing prior to use.

Regulatory and Certification

• 510(k) Cleared• CE Mark• NGSP Certified• Referenced to IFCC Standard• Health Canada Medical Device Licensed

Market: Diabetes Testing

Pointe Scientific Hemoglobin A1c Assay:Streamlining diabetes testing with a 2-part HbA1c assay

Figure 1:Diabetes population per IDF diabetes Atlas Eighth Edition 2017

800.445.9853(International) +1.734.487.8300 www.medtestdx.com