Breathalyzer Specifications

BACTRACK® B70

Digital Breathalyzer

Dimension

4.25 x 1.63 x 0.81 inches

Weight

1.4 oz

(39.7 grams)

Breathalyzer Sensor

Patent Pending BluFire®

Detection Range

0.00 %BAC – 0.40 %BAC

Internal Memory

Displays total number of tests performed

Power Supply

Two AA batteries, not included

Battery Life

At least 300 tests

Warm-up Time

5 seconds

Test Duration

5 seconds

Response Time

3 seconds

Breathalyzer Accuracy

+/- 0.01 %BAC @ 0.02 %BAC

Operating Temperature

50-104 °F

(10-40 °C)

Food & Drug Administration Approval

Market Clearance

510(k) Premarket Clearance: Granted For Over-The-Counter Use.

Identification of the Device

BACTRACK® Breathalyzer Digital Alcohol Detector: Breath-Alcohol Test System.

Indications for Use

This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.

Description of Device

The BACTRACK is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry’s Law in ratio of 2100:1.

The BACTRACK Breathalyzer has been tested and uses a blow time of of 5 seconds to capture an accurate deep lung sample. The BACTRACK Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance.

If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.

Safety and Effectiveness

The results of bench, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester.

The BACTRACK® B70 versus The AlcoMate® CA2000

Feature	AlcoMate CA2000 Digital Alcohol Detector	BACTRACK Breathalyzer
Intended Use	This device is intended to measure alcohol in the human breath.	SAME
Mode	Breath Alcohol Concentration	SAME
Practitioner Use	Over The Counter (OTC)	SAME
Blowing Time	5 Seconds	SAME
Display	3 Digit LED	3 Digit LCD
Power Source	9 Volt Alkaline Battery	2 - AA Alkaline
Battery Life	300 Tests	SAME
Measurement Range	.00 - .40% Blood Alcohol Concentration	SAME
Accuracy	+/-0.01%	SAME
Type of Sensor	Semiconductor-Oxide Sensor	BluFire Semiconductor Tin Dioxide Sensor
Anatomical Site	Mouth	SAME
Mouthpiece	Replaceable	No Mouthpiece
Warm Up Time	20 Seconds	10 Seconds
DOT	DOT Approved	Meets DOT Requirements
Construction	Plastic case with internal cirucit board	SAME
Size	5″x3.25″x1.2″ (12.7 x 8.3 x 3.1 cm)	4.25″ x 1.63 “x 0.81″ (10.8 x 4.1 x 2.1 cm)
Weight	200 grams	1.4 oz (39.7 grams)