(252 days)
Not Found
No
The device description details a purely chemical reaction for detection, with no mention of computational analysis, algorithms, or learning processes.
No
The device is described as a "screening device" used to "detect the presence of alcohol in the human breath" and is "only an indication of the possible presence of alcohol." It does not mention any therapeutic use, treatment, or mitigation of a condition.
Yes
The device is described as an "in vitro medical device to qualitatively detect the presence of alcohol in the human breath," making it a diagnostic device for screening purposes.
No
The device description clearly outlines physical components like glass tubing, reagent crystals, and an opening to blow into, indicating it is a hardware-based device, not software-only.
Yes, based on the provided information, the Alco Tube Plus Alcohol Detector is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro medical device to qualitatively detect the presence of alcohol in the human breath." This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and body fluids, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. While breath isn't a traditional "body fluid" in the same way as blood or urine, it is a specimen derived from the human body that is being analyzed in vitro (outside the body) to provide information about a physiological state (presence of alcohol).
- Device Description: The device works by analyzing a specimen (breath) outside the body using a chemical reaction with a reagent. This is a hallmark of IVD devices. The chemical change in the crystals is the diagnostic indicator.
- Specimen: The specimen being tested is human breath.
- Purpose: The purpose is to detect the presence of alcohol, which is a physiological state.
Therefore, the Alco Tube Plus Alcohol Detector fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DJZ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing of the Alco Tube Plus was performed to DOT/NHTSA approved device (Conforming Products List of Evidentiary breath Measurement Devices - FR/Vol. 69, 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.
0.05 tester result (n=200):
Less than cutoff - 60% ( 0.05 - 0.083%): Positive 70, Negative 0
Greater than cutoff + 60% (> 0.083): Positive 21, Negative 0
0.08 tester result (n=200):
Less than cutoff – 60% (0.05 – 0.083%): Positive 70, Negative 0
Greater than cutoff + 60% (> 0.083): Positive 21, Negative 0
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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 | |
| in the human breath. | Detect the presence of alcohol | |
| 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- | |
| calibrated to turn color at | ||
| different cut-offs: | ||
| .05% and .08% | Separate devices are pre- | |
| calibrated to turn color at | ||
| different cut-offs: .02%, .04%, | ||
| .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 | ||||
| (n=200) | Less than | |||
| cutoff - 60% | ||||
| ( 0.05 - 0.083%) | Greater than | |||
| cutoff + 60% | ||||
| (> 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 | ||||
| (n=200) | Less than | |||
| cutoff – 60% | ||||
| (0.05 – 0.083%) | Greater than | |||
| cutoff + 60% | ||||
| (> 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.
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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).
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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
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