ALCO TUBE PLUS

{0}------------------------------------------------ KOR2020 # 510(k) Summary 807.92(c) # APR = 1 2009 SPONSOR 807.92(a)(1) Company Name: Alcotest Quebec Company Address 3075 Peugot Laval, CA-QC H7L 5C4 Canada Telephone: Fax: 450-666-2500 450-666-2501 Contact Person: Stephane Maurais Summary Preparation Date: July 18, 2008 ### DEVICE NAME Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Alco Tube Plus Alcohol Detector Breath-alcohol test Devices, Breath Trapping, Alcohol CFR21 862.3050 DJZ Class I ### PREDICATE DEVICE Legally Marketed Equivalent Device: Company Product 510(k) # Akers Biosciences, Inc. BreathScan® Alcohol Detector K060761 ### 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 ### 807.92(a)(4) 807.92(a)(3) 807.92(a)(2) {1}------------------------------------------------ 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 ## DEVICE 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 onetime 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. Correlation between breath alcohol content and blood alcohol content depends on many variables. Alco Tube Plus is not intended to legally determine blood alcohol presence, level, or inference of intoxication. | Parameters | Alco Tube Plus | BreathScan® | |-----------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | 510(k) Number | N/A | K060761 | | Indented Use Statement | Detect the presence of alcohol<br>in the human breath. | Detect the presence of alcohol<br>in the human breath. | | Target Population | Over the Counter | Over the Counter | | Calibration/Accuracy Checks | None required | None required | | Anatomical Site | Mouth | Mouth | | Test Sample | Human breath | Human breath | | Result | Qualitative | Qualitative | | Interpretation | Visual Color Change | Visual Color Change | | Measurement Range | Separate devices are pre-<br>calibrated to turn color at<br>different cut-offs:<br>.05% and .08% | Separate devices are pre-<br>calibrated to turn color at<br>different cut-offs: .02%, .04%,<br>.05%, and .08% | | Mouthpiece | None Required | None Required | | Blowing Time | 12 seconds | 12 Seconds | | Warm-up time | none | None | | Size | 10 cm | 2¾ by 1/3 inches | | Weight | 6,8 grams | 1.9067 grams | | Power Requirement | none | None | #### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) ## NONCLINICAL AND CLINICAL TEST ## 807.92(b) 807.92(a)(5) ## SAFETY and EFFECTIVENESS Testing of the Alco Tube Plus was performed to DOT/NHTSA approved device (Conforming Products List of Evidentiary breath Measurement Devices - FR/Vol. 69, {2}------------------------------------------------ No. 134/July2004/Notices/42237. User studies were performed to establish that the user could read and understand the directions provided and properly use the device. | | Quantitative Results | | | | |-------------------------------|---------------------------------------|-------------------------------------------|----------------------------------------------|-------------------------------------------| | 0.05 tester result<br>(n=200) | Less than<br>cutoff - 60%<br>(<0.02%) | Near cutoff<br>negative<br>(0.02 - 0.05%) | Near cutoff<br>positive<br>(> 0.05 - 0.083%) | Greater than<br>cutoff + 60%<br>(> 0.083) | | Positive | 0 | 0 | 70 | 21 | | Negative | 80 | 29 | 0 | 0 | | Table 1 | | | | | |--------------------------------------------------------|--|--|--|--| | Comparison to Evidentiary Breath Test (Alco-Sensor IV) | | | | | | Table 2 | | | | | |--------------------------------------------------------|--|--|--|--| | Comparison to Evidentiary Breath Test (Alco-Sensor IV) | | | | | | | Quantitative Results | | | | |-------------------------------|----------------------------------------|-------------------------------------------|---------------------------------------------|-------------------------------------------| | 0.08 tester result<br>(n=200) | Less than<br>cutoff – 60%<br>(< 0.02%) | Near cutoff<br>negative<br>(0.02 – 0.05%) | Near cutoff<br>positive<br>(>0.05 – 0.083%) | Greater than<br>cutoff + 60%<br>(> 0.083) | | Positive | 0 | 0 | 70 | 21 | | Negative | 80 | 29 | 0 | 0 | ## CONCLUSION ## 807.92(b)(3) After analyzing bench test and user testing data, it is the conclusion of Alcotest Quebec that the Alco Tube Plus Breath Alcohol Detector is as safe and effective as the predicate device. User studies showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device and obtain results that were comparable to those of the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Alcotest Quebec c/o Mr. E.J. Smith 1468 Harwell Ave Crofton, MD 21114 Re: k082080 Trade/Device Name: Breath Alcohol Detector Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-Alcohol test system Regulatory Class: Class I, Reserved Product Codes: DJZ Dated: March 25, 2009 Received: March 26, 2009 APR - 1 2009 Dear Mr. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {4}------------------------------------------------ Page - 2 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Corg C. He Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health {5}------------------------------------------------ # Indications for Use 510(k) Number K082080 Device Name: Alco Tube Plus Alcohol Detector Indications For 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. Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use V. (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Ruta Chiles Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K082080 Page 1 of 1