SleepCheck
SleepCheck checks a hormone called melatonin that helps regulate your sleep patterns, mood, and cell functions using a saliva sample. Abnormal melatonin levels can cause insomnia, cardiovascular & ovulation problems, immune disorders, irregular body temp
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 Cole-Taylor 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
Biorad 1
Roche
1.015
6.5
0.2
CTMI-R
6.0
Level 2
Biorad 2
3+
Unreadable
4+
1.010
7.5
8.0
Positive
7.0
Patient ID
Color
Charact.
1
Yellow
Clear
2
Trace
Sl. Cloudy
1+
1.020
3
2+
4
1015
Cloudy
5
RocheNegativ
`Negative
1.025
6
4.0
CTMI-RNegative
4.0Negative
_
7
8
0.2Negative
9
__
10
_Trace
_0.2
11
1.030
12
1.005
Trace-Int.
13
CTMI VS Chemstrip BE.xls CTMI VS Chemstrip BE.xls
14
15
16
17
18
19
20
21
