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AlcoHawk Pro breathalyzer

AlcoHawk Pro is FDA/DOT/NHSTA approved breathalyzer. Great for schools, parents, employers, etc. It takes a deeper breath sample and provides more accurate results than similar models, FlowCheck Technology ensures enough air is blown into the machine.

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Germaine Labs AimStrip Urine Test Parameter Descriptions

CLINITEK 50 STUDY

Test performed by: Bobby Echard, MT

Certified by AMT – American Medical Technologist Test Site – Physician Clinic

Number of patients: 20

MEDTECH commissioned me to perform a study on a Urine Reagent Strip manufactured for Cole-Taylor Marketing, Inc. (CTMI) and the Bayer® Corporation. Tests were performed using strict clinical laboratory protocols under my personal supervision.

The purpose of this validation is to demonstrate the performance characteristics of the Germaine Labs Marketing, Inc. Urine Reagent Strip on the Bayer® Clinitek 50™ Analyzer. The Urine Reagent Strip is FDA 510K-cleared under, K993850.

As you can see in the report – there are no significant differences between the CTMI Urine Strips when compared to the Bayer Urine Strips when run on the Clinitek 50™ analyzer. There were slight variances of +/- 1 block due to the variability in testing.

These tests were performed and recorded using a Bayer – Clinitek 50 unit (see attachment “B” for the results of finding using the Clinitek 50 machine).

It is therefore my opinion – there are no significant differences between the CTMI Urine Strips and Bayer Urine Strips when run on the Clinitek 50™ analyzer

Bobby Echard, MT

 

 

CTMI-R vs Roche Comparison utilizing the visual method.

 

 

LEVEL 1

Control

Urine Strip

Glucose

Bilirubin

Ketone

Sp. Grav.

Blood

pH

Protein

Urobil.

Nitrites

Leukocytes

Negative

Negative

Biorad 1

Roche

Negative

Negative

Negative

1.015

Negative

6.5

Negative

0.2

Negative

Negative

Biorad 1

CTMI-R

Negative

Negative

Negative

1.015

Negative

6.0

Negative

0.2

Level 2

 

 

 

 

 

 

 

 

 

Biorad 2

Roche

3+

Unreadable

4+

1.010

4+

7.5

3+

8.0

Positive

3+

Biorad 2

CTMI-R

3+

Unreadable

3+

1.015

4+

7.0

3+

8.0

Positive

3+

 

Patient ID

Urine Strip

Glucose

Bilirubin

Ketone

Sp. Grav.

Blood

pH

Protein

Urobil.

Nitrites

Leukocytes

Color

Charact.

1

Roche

Negative

Negative

Negative

1.015

Negative

6.5

Negative

0.2

Negative

Negative

Yellow

Clear

1

CTMI-R

Negative

Negative

Negative

1.015

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

2

Roche

4+

Negative

Trace

1.015

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Sl. Cloudy

Sl. Cloudy

2

CTMI-R

3+

Negative

1+

1.020

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

3

Roche

3+

Negative

Negative

1.010

Negative

6.5

Negative

0.2

Negative

Negative

Yellow

Sl. Cloudy

Sl. Cloudy

3

CTMI-R

2+

Negative

Negative

1.015

Negative

6.5

Negative

0.2

Negative

Negative

Yellow

4

Roche

Negative

Negative

Negative

1015

Negative

6.5

Negative

0.2

Positive

Negative

Yellow

Sl. Cloudy

Sl. Cloudy

Cloudy

Cloudy

4

CTMI-R

Negative

Negative

Negative

1.020

Negative

6.5

Negative

0.2

Positive

Negative

Trace

Yellow

Yellow

5

 

RocheNegativ

Negative

`Negative

1.020

2+

6.0

Negative

0.2

Positive

5

CTMI-R

Negative

Negative

Negative

1.025

3+

6.0

Trace

0.2

Positive

Trace

Yellow

6

Roche

Negative

Negative

1+

1.020

Trace

7.0

Negative

4.0

Negative

Negative

Yellow

Cloudy

Cloudy

Cloudy

Cloudy

6

 

CTMI-RNegative

Negative

2+

1.020

Trace

6.5

Trace

4.0Negative

 

Negative

Yellow

_

7

Roche

Negative

_

Negative

Negative

1.010

Negative

8.0

Negative

0.2

Negative

_

Negative

Yellow

7

CTMI-R

Negative

Negative

Negative

1.015

Negative

8.0

Trace

0.2

Negative

Negative

Yellow

8

Roche

Negative

Negative

2+

1.015

Negative

7.5

Negative

0.2

Negative

Trace

Yellow

Sl. Cloudy

Sl. Cloudy

Cloudy

Cloudy

8

 

CTMI-RNegative

Negative

3+

1.015

Negative

7.0

Negative

0.2Negative

 

Trace

Yellow

Yellow

_

9

Roche

Negative

_

Negative

Negative

_

1.020

Negative

7.0

Negative

0.2

Negative

__

Negative

9

CTMI-R

Negative

Negative

Negative

1.020

Negative

6.5

Trace

0.2

Negative

Negative

Yellow

10

Roche

Negative

Negative

Negative

1.025

Trace

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

10

CTMI-R

Negative

Negative

Negative

1.025

_Trace

6.0

Negative

_0.2

Negative

Negative

Yellow

Clear

11

Roche

Negative

Negative

Trace

1.030

Negative

6.0

Trace

0.2

Negative

Negative

Yellow

Cloudy

Cloudy

11

CTMI-R

Negative

Negative

Trace

1.030

Negative

6.0

Trace

0.2

Negative

Negative

Yellow

12

Roche

Negative

Negative

Negative

1.005

Trace-Int.

7.5

Negative

0.2

Negative

Negative

Yellow

Clear

12

CTMI-R

Negative

Negative

Negative

1.005

Negative

7.5

Negative

0.2

Negative

Negative

Yellow

Clear

13

Roche

Negative

Negative

Negative

1.025

Negative

7.5

Negative

0.2

Negative

Negative

Yellow

Clear

13

CTMI-R

Negative

Negative

Negative

1.020

Negative

7.5

Negative

0.2

Negative

Negative

Yellow

Clear

 

 

CTMI VS Chemstrip BE.xls   CTMI VS Chemstrip BE.xls

CTMI-R vs Roche Comparison utilizing the visual method.

 

 

LEVEL 1

Control

Urine Strip

Glucose

Bilirubin

Ketone

Sp. Grav.

Blood

pH

Protein

Urobil.

Nitrites

Leukocytes

Negative

Negative

Biorad 1

Roche

Negative

Negative

Negative

1.015

Negative

6.5

Negative

0.2

Negative

Negative

Biorad 1

CTMI-R

Negative

Negative

Negative

1.015

Negative

6.0

Negative

0.2

Level 2

 

 

 

 

 

 

 

 

 

Biorad 2

Roche

3+

Unreadable

4+

1.010

4+

7.5

3+

8.0

Positive

3+

Biorad 2

CTMI-R

3+

Unreadable

3+

1.015

4+

7.0

3+

8.0

Positive

3+

 

Patient ID

Urine Strip

Glucose

Bilirubin

Ketone

Sp. Grav.

Blood

pH

Protein

Urobil.

Nitrites

Leukocytes

Color

Charact.

14

Roche

Negative

Negative

Trace

1.020

Negative

6.0

1+

0.2

Negative

Negative

Yellow

Sl. Cloudy

Sl. Cloudy

14

CTMI-R

Negative

Negative

Trace

1.020

Negative

6.5

Trace

0.2

Negative

Negative

Yellow

15

Roche

Trace

Negative

Negative

1.030

1+

6.0

1+

0.2

Negative

Negative

Yellow

Cloudy

Cloudy

15

CTMI-R

Trace

Negative

Trace

1.030

Trace

6.0

1+

0.2

Negative

Negative

Yellow

16

Roche

3+

Negative

2+

1.005

3+

7.5

Negative

0.2

Negative

Negative

Yellow

Clear

16

CTMI-R

2+

Negative

2+

1.005

3+

6.5

Trace

0.2

Negative

Negative

Yellow

Clear

17

Roche

Negative

Negative

2+

1.015

Trace

8.0

Trace

0.2

Negative

3+

Yellow

Cloudy

Cloudy

Cloudy

Cloudy

17

CTMI-R

Negative

Negative

1+

1.015

Trace

7.5

1+

0.2

Negative

3+

Yellow

18

Roche

Negative

Negative

Trace

1.020

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

18

CTMI-R

Negative

Negative

Trace

1.020

Negative

6.0

Trace

0.2

Negative

Negative

Yellow

19

Roche

Negative

Negative

1+

1.010

Negative

7.0

Negative

0.2

Negative

Negative

Yellow

Clear

19

CTMI-R

Negative

Negative

1+

1.010

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

20

Roche

Negative

Negative

Negative

1.010

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

20

CTMI-R

Negative

Negative

Negative

1.010

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

21

Roche

Negative

Negative

Negative

1.015

Negative

6.0

Negative

0.2

Negative

Negative

Yellow

Clear

21

CTMI-R

Negative

Negative

Negative

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