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510(k) Data Aggregation
K Number
K160613Device Name
Soberlink Cellular Device and Sober Sky Web Portal
Manufacturer
SOBERLINK HEALTHCARE LLC
Date Cleared
2016-07-14
(133 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath.
Indications for Use
Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
For Prescription use and OTC use.
Device Description
The Soberlink Cellular Device is a handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem. It is designed to take a deep lung sample of the User's breath, calculate their Blood Alcohol Level (BAC), and send the BAC reading, physical location, and digital image of the User to the Sober Sky Web Portal and Device screen for review.
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K Number
K123470Device Name
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
Manufacturer
PAS SYSTEMS INTERNATIONAL, INC.
Date Cleared
2013-04-29
(167 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
The PAS Alcovisor® Mars™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Device Description
The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer are breath alcohol test systems designed to sample a user's deep lung breath in order to test for the presence of alcohol. The sensor is an electrochemical fuel cell which will only respond to alcohol. After the user blows into the device using a disposable mouthpiece, for 3-4 seconds, a small sample of breath is drawn into the fuel cell by an automatic pump and a chemical reaction between the alcohol and fuel cell occurs. This reaction generates an electrical current which is directly related to the amount of alcohol in the sample. The current is then converted to a Blood Alcohol Concentration (BAC) level and displayed for the user. The relationship between alcohol in a person's deep lung breath and in their blood is well established using Henry's law, which gives a ratio of 2100:1.
The Satellite™ and Mars™ are handheld devices made from durable plastic with an internal circuit board. The Satellite™ uses an internal rechargeable battery and the Mars™ uses three AAA batteries.
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K Number
K110614Device Name
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
Manufacturer
SEJU ENGINEERING CO., LTD.
Date Cleared
2011-11-21
(263 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
Device Description
The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration , high concentration, respectively. The unit is powered by two AAA batteries.
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K Number
K102225Device Name
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
Manufacturer
ALCOPRO, INC.
Date Cleared
2011-04-06
(240 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.
The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.
Device Description
The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results.
The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use.
The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results.
The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.
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K Number
K102338Device Name
BREATHSCN PRO
Manufacturer
Akers Biosciences, Inc.
Date Cleared
2011-01-12
(147 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.
Device Description
The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors.
The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.
The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology. The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test.
When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected.
The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.
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K Number
K100879Device Name
CONTRALCO
Manufacturer
CONTRALCO
Date Cleared
2010-08-04
(127 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
Device Description
The Contralco Alcohol Breath Tester is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors. The Tester is made up of 2 parts: the reagent and the plastic bag. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part (plastic bag) collects the volume of air necessary for the analysis. If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath. The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
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K Number
K093143Device Name
MISSION BREATH ALCOHOL DETECTOR
Manufacturer
ACON LABORATORIES, INC.
Date Cleared
2010-01-28
(115 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Device Description
The Breath Alcohol Detector is a visual semi-quantitative test for the detection of alcohol in the exhaled breath. The Breath Alcohol Detector consists of a plastic tube, two plastic plugs, a blow bag (optional), a tube label and a glass vial encased with reaction crystals. The crystals employ a solid-phase chemistry system based on chemically chromogenic reaction. Alcohol, if present in the exhaled breath, reacts with the chemically coated crystals and produces a color change. This color change is proportional to the concentration of alcohol in the breath, which is an approximation of relative Blood Alcohol Concentration (BAC). The Breath Alcohol Detector is available with or without blow bags in six cut-off levels: 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.
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K Number
K091714Device Name
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
Manufacturer
SKYFINE INC. LIMITED
Date Cleared
2009-11-18
(161 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Device Description
The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.
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K Number
K090766Device Name
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
Manufacturer
LIFELOC TECHNOLOGIES, INC.
Date Cleared
2009-07-23
(122 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.
The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.
The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.
The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.
Device Description
The LifeGuard product is a breath alcohol detector designed to sample the patient's deep lung air in order to test for the presence of alcohol in the blood. The sensor used in the LifeGuard is an electrochemical fuel cell sensor. When the patient exhales into the device, after 4 seconds a sample of the breath is pumped into the fuel cell and generates an electrical current. The amount and duration of the current has a known relationship to the concentration of alcohol in the breath sample. The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1.
The BacTrack B90 has the same intended use, description and performance characteristics as the LifeGuard with a different physical appearance.
Both the LifeGuard and BacTrack B90 products are handheld and are used with a single-use disposable mouthpiece and a replaceable 9 volt battery.
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K Number
K082080Device Name
ALCO TUBE PLUS
Manufacturer
ALCOTEST QUEBEC
Date Cleared
2009-04-01
(252 days)
Product Code
DJZ, DEV
Regulation Number
862.3050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available in two cut-offs including 0.05 and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
Device Description
The Alco Tube Plus Alcohol Detector (Tester) is a visual qualitative test for the presence of alcohol in human breath. The tester is constituted of glass tubing containing a reagent of yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to green. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals are coated with Potassium dichromate and sulfuric acid. The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate. The majority of crystals change from yellow to green when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The Alco Tube Plus is available in two cut-offs (0.05%) The cut-off is printed in the instructions and is expressed as a specific percentage of breath alcohol
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