ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST by ALCOPRO, INC.

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.

AI/ML Overview

The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are intended to detect the presence of alcohol in breath. The summary provides details on the performance evaluation studies conducted and the standards followed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document references "Performance Specifications" and lists several analytical performance tests, but it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format. It only lists the types of tests conducted:

Acceptance Criteria Category	Reported Device Performance
Precision/ Reproducibility	Studies were conducted. (Specific values not provided)
Traceability/ Stability/ Expected Values	Studies were conducted. (Specific values not provided)
Detection Limit	Studies were conducted. (Specific values not provided)
Analytical Specificity (cigarette smoke, temperature, vibration)	Studies were conducted. (Specific values not provided)
Comparison Studies	Studies were conducted. (Specific values not provided)
Usability	Usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert. (No specific metrics or success rates provided)

The document states: "The conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. 'Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids'." This implies that the acceptance criteria are derived from this guidance, but the concrete thresholds are not explicitly stated in this document.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "performance evaluation studies" and "usability tests" but does not quantify the number of samples or participants.
Data Provenance: Not explicitly stated. The document refers to NHTSA/DOT guidance, which is a national standard for alcohol screening devices in the US, suggesting the data would likely be from studies conducted within the US, but this is not definite. It also doesn't specify if the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not explicitly stated. The document does not mention the use of experts for establishing ground truth, nor their number or qualifications. The comparative effectiveness study is referenced in the context of the device's performance against established standards, not against expert consensus.

4. Adjudication Method for the Test Set:

Not applicable/Not explicitly stated. The document does not describe an adjudication method. The device provides "preliminary screening test results" based on a visual color change in a chemical reaction. The interpretation is based on observation.

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

Was it done? No. The document does not describe a MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device itself is a standalone, single-user chemical test with visual interpretation, not an AI-assisted diagnostic tool for human readers.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence. The Alco-Breath Tube and CheckPoint® Breath Alcohol Test are described as "disposable, one-time use in vitro diagnostic (IVD) device[s] using a length-of-stain method to give estimates of alcohol concentrations" or "using a color change to indicate the presence of alcohol." The "device provides preliminary screening test results and is not intended to be used as evidential results." The mechanism is a chemical reaction with visual interpretation by the user, making it a standalone test where the device's chemical reaction (analogous to an algorithm in this context) directly produces the result for human interpretation. The "usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert," which suggests a human-in-the-loop component for interpretation, but the core "algorithm" (chemical reaction) is standalone.

7. Type of Ground Truth Used:

The ground truth for the performance evaluation studies (Precision/Reproducibility, Detection Limit, Analytical Specificity, Comparison Studies) is implicitly based on reference alcohol concentrations used in laboratory settings, as dictated by the NHTSA/DOT guidance mentioned. The comparison studies would involve comparing the device's results against established methods of measuring alcohol concentration to verify accuracy.

8. Sample Size for the Training Set:

Not applicable. This device is a chemical screening test, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the word "ALCO" in bold, black letters. Above the word "ALCO" are several horizontal lines of varying lengths, creating a striped effect. A horizontal line underlines the word "ALCO", emphasizing the brand name. The overall design is simple and graphic, likely representing a logo or brand identifier.

510(k) SUMMARY

APR - 6 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:	K102225
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Submitted By:	AlcoPro, Inc.2547 Sutherland AvenueKnoxville, TN 37939USATelephone: 1-800 227-9890
Company Contact:	Jack Singleton, President
Date Summary Prepared:	7/26/2010
Trade Name:	Alco-Breath Tube;CheckPoint® Breath Alcohol Test
Common Name:	Devices, Breath trapping, alcohol
Regulation Number and Panel:	862.3050 - Toxicology
Classification Product Code:	DJZ
Classification:	Class I
Substantially Equivalent Devices:	K060761 - BreathScan Alcohol Detector

Device Description:

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Image /page/1/Picture/0 description: The image shows the word "ALCO" in bold, black letters. To the right of the word, there are several horizontal lines that are also in black. The lines are stacked on top of each other and are of varying lengths. A horizontal line is present underneath the word "ALCO".

510(k) SUMMARY

Intended Use/ Indications for Use:

Device Name: Alco-Breath Tube breath alcohol test

Device Name: CheckPoint breath alcohol test

Predicate Device:

The predicate device(s) for substantial equivalence in this submission are:

Device Name	BreathScan Alcohol Detector
Company	Akers Biosciences, Inc.
510(k) reference	K060761

Technology Comparison:

Feature	Predicate Device:BreathScan® Alcohol Detector(K060761)	New Device:Alco-Breath Tube	New Device:CheckPoint® BreathAlcohol Test
Intended Use	Detect presence of alcohol inexhaled breath	Same as predicate	Same as predicate

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Image /page/2/Picture/0 description: The image shows the logo for ALCO. The letters are in bold, sans-serif font. There are several horizontal lines to the right of the letters, which are stacked on top of each other.

Feature	Predicate Device:BreathScan® Alcohol Detector(K060761)	New Device:Alco-Breath Tube	New Device:CheckPoint® BreathAlcohol Test
Target Population	Over the counter	Same as predicate	Same as predicate
Calibration/Accuracy Checks	None required	Same as predicate	Same as predicate
Methodology	Chromogenic reaction	Same as predicate	Same as predicate
Anatomical Site	Mouth	Same as predicate	Same as predicate
Test Sample	Exhaled human breath	Same as predicate	Same as predicate
Blowing Time	12 seconds	1 minute	Same as predicate
Test Time	2 minutes	Same as predicate	Same as predicate
Result	Qualitative	Same as predicate; alsoprovides semi-quantitative results	Same as predicate
Interpretive Method	Visual Color Change	Same as predicate	Same as predicate
Measuring Units	BAC %	Same as predicate	Same as predicate
MeasurementRange	Separate devices available atdifferent cut-off levels: 0.02%,0.04%, 0.05%, and 0.08%	Separate devicesavailable at differentcut-off levels: 0.04%and 0.08%	Same as predicate
Mouthpiece	None Required	Same as predicate	Same as predicate
Collection Device	None Required	Balloon	Optional volumetric bag

510(k) SUMMARY

Test Summary:

Performance data - Non-clinical/ Clinical

The conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. "Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids". (Federal Register: March 31, 2008. Vol 73, No.62, pgs. 16956 - 16960). This is the only national standard available for alcohol screening devices and is the same standard referenced in the 510(k) clearance for the predicate device. Usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert.

Performance Specifications -

The performance characteristics of the Alco-Breath Tube and CheckPoint® Breath Alcohol Test were based on evaluations by the following analytical performance tests:

Precision/ Reproducibility 트
l Traceability/ Stability/ Expected Values
Detection Limit
Analytical Specificity
- o cigarette smoke
- temperature o
- o vibration
Comparison Studies

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510(k) SUMMARY

Conclusions:

The information in this 510(k) submission demonstrates that the Alco-Breath Tube and CheckPoint® Breath Alcohol Test is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

APR 6 2011

Alcopro, Inc., c/o Seashore-Tetrachem Attn:Mr. Perry Rucker Consultant. Regulatory Affairs, & Compliance 1560 E. Edinger Avenue, Suite B Santa Ana. CA 92705

Re: K102225

Trade Name: Alco-Breath Tube, Checkpoint Breath Alcohol Test Regulation Number: 21 CFR §862.3050 Regulation Name: Breath Alcohol Test System. Regulatory Class: Class I, reserved Product Codes: DJZ Dated: February 10, 2011 Received: February 15, 2011

Dear Mr. Rucker:

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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 102225

Device Name: CheckPoint breath alcohol test

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102225

Section 4, page Lof 2

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510(k) Number (if known): 102225

Device Name: Alco-Breath Tube breath alcohol test

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102221

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.