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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Alco Tube Plus Alcohol Detector, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in terms of specific performance metrics that the device must meet (e.g., minimum sensitivity, specificity, or accuracy thresholds). Instead, the study's aim was a "Comparison to Evidentiary Breath Test (Alco-Sensor IV)" and to demonstrate that the device is "as safe and effective as the predicate device." The tables provided show the device's performance against different quantitative breath alcohol levels.

Therefore, the "acceptance criteria" can be inferred as the device demonstrating reliable qualitative detection of alcohol at its specified cut-offs (0.05% and 0.08%) when compared to an evidentiary breath test, with no false positives below these cut-offs and clear positive indications at or above them.

Metric / Performance Aspect	Acceptance Criteria (Inferred)	Reported Device Performance (0.05% cut-off)	Reported Device Performance (0.08% cut-off)
Qualitative Detection at Cut-off	The device should correctly indicate "positive" when breath alcohol levels are at or above the stated cut-off, and "negative" when below. Specifically, no false positives for levels clearly below the cut-off, and consistent positives for levels clearly above.	Positive Results: - Near cutoff positive (> 0.05 - 0.083%): 70 - Greater than cutoff + 60% (> 0.083%): 21Negative Results: - Less than cutoff - 60% (<0.02%): 80 - Near cutoff negative (0.02 - 0.05%): 29 - Significantly, 0 false positives below the cut-off and 0 false negatives above 0.05 - 0.083%.	Positive Results: - Near cutoff positive (>0.05 – 0.083%): 70 - Greater than cutoff + 60% (> 0.083%): 21Negative Results: - Less than cutoff – 60% (< 0.02%): 80 - Near cutoff negative (0.02 – 0.05%): 29 - Significantly, 0 false positives below the cut-off and 0 false negatives above 0.05 – 0.083%.
User Comprehension and Proper Use	Users should be able to read and understand the directions, and properly use the device.	User studies were performed to establish that the user could read and understand the directions provided and properly use the device. The conclusion states: "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."	User studies were performed to establish that the user could read and understand the directions provided and properly use the device. The conclusion states: "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."
Comparability to Predicate Device and Evidentiary Test	The device's performance should be comparable to the legally marketed predicate device (BreathScan® Alcohol Detector) and aligned with results from a DOT/NHTSA approved evidentiary breath measurement device (Alco-Sensor IV).	The summary concludes: "the Alco Tube Plus Breath Alcohol Detector is as safe and effective as the predicate device." The data tables show direct comparison to the Alco-Sensor IV.	The summary concludes: "the Alco Tube Plus Breath Alcohol Detector is as safe and effective as the predicate device." The data tables show direct comparison to the Alco-Sensor IV.

2. Sample Size and Data Provenance for the Test Set

Sample Size:
- For the 0.05% cut-off tester: n=200
- For the 0.08% cut-off tester: n=200
Data Provenance: The document does not explicitly state the country of origin. The test was conducted for submission to the FDA in the US, but the company is based in Canada. It's retrospective in the sense that the data is presented from a completed study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "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..." This implies that the ground truth was established by a DOT/NHTSA approved evidential breath test device (Alco-Sensor IV), which is considered a gold standard for quantitative breath alcohol measurement, rather than human experts interpreting results.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an independent, quantitative, and objective evidentiary breath test device (Alco-Sensor IV), not through human expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a visual qualitative self-test, not an AI-assisted diagnostic tool that would typically involve human readers. The user studies focused on whether an individual user could understand and properly use the device.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The tables provided show the performance of the Alco Tube Plus (with both 0.05% and 0.08% cut-offs) in detecting alcohol against quantitative breath alcohol levels measured by an Alco-Sensor IV, without human interpretation influencing the Alco Tube Plus's color change (though human interpretation is needed to read the result of the Alco Tube Plus). The study effectively demonstrates the device's ability to trigger a color change at specific breath alcohol concentrations.

7. Type of Ground Truth Used

The ground truth used was quantitative breath alcohol measurements obtained from a DOT/NHTSA approved evidentiary breath measurement device, specifically the Alco-Sensor IV. This is an objective and highly accurate method for determining breath alcohol content.

8. Sample Size for the Training Set

The document does not describe a separate "training set" or "training process" as would be typical for machine learning or AI models. This device is a chemical qualitative test, not an algorithm that learns from data. Its "calibration" is inherent in the chemical composition of the crystals adjusted for the desired cut-off.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no "training set" in the context of this chemical indicator device. The "adjustment according to the selected cutoff" of the indicator chemicals would be based on chemical engineering principles and validated through testing, not through a data-driven training process with established ground truth labels like an AI model.

Summary

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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

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)

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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 alcoholin the human breath.	Detect the presence of alcoholin 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 atdifferent cut-offs:.05% and .08%	Separate devices are pre-calibrated to turn color atdifferent 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,

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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 thancutoff - 60%(<0.02%)	Near cutoffnegative(0.02 - 0.05%)	Near cutoffpositive(> 0.05 - 0.083%)	Greater thancutoff + 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 thancutoff – 60%(< 0.02%)	Near cutoffnegative(0.02 – 0.05%)	Near cutoffpositive(>0.05 – 0.083%)	Greater thancutoff + 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

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Indications for Use

510(k) Number K082080

Device Name: Alco Tube Plus Alcohol Detector

Indications For Use:

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

Regulation Number and Section

§ 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.