This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.

Device Description

Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC < 0.05. The device also includes a flashlight function and a count-up/count-down timer. The timer can be used for parking meter timing or for timing the wait before performing the alcohol test after consuming alcohol, nominally 20 minutes.

AI/ML Overview

The Protocol Alcohol Breath Checker is a breath-alcohol test system designed to measure alcohol in human breath for the diagnosis of alcohol intoxication.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (K052448, Connectables Pocket Breathalyzer) rather than explicitly stating acceptance criteria with specific numerical targets. However, based on the comparison provided and the ultimate conclusion, we can infer some key performance aspects being "accepted" as equivalent to the predicate.

Feature	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (Protocol Alcohol Breath Checker)
Accuracy	+/- 0.01% BAC	SAME (implied to be +/- 0.01% BAC)
Measurement Range	0.00-0.40% BAC	SAME (0.00-0.40% BAC)
Blowing Time	3 Seconds	3 Seconds
Display Interpretation	Red: BAC > 0.08, Yellow: BAC 0.04 to 0.08, Green: BAC < 0.04	Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC < 0.05
Battery Life	400 Tests	300 Tests
Warm-Up Time	5-15 seconds	SAME (5-15 seconds)
Overall Safety and Effectiveness	Equivalent to predicate device K052448	Demonstrated to be as safe and effective as predicate
User Understanding & Proper Use	Users can read, understand instructions & properly use device	Demonstrated in clinical trial
Performance Comparability to Evidentiary Devices	Comparable to an evidentiary type of breath alcohol tester	Demonstrated in clinical trial

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

Sample Size: The exact sample size for the "clinical trial" is not explicitly stated in the provided documents. The text mentions "user testing" and "a clinical trial was performed" but does not give a number of participants.
Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies prospective data collection.

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

Number of Experts: Not applicable in the traditional sense of expert-reviewed images or diagnoses.
Qualifications of Experts: The ground truth for direct BAC values would have been established by an "evidentiary type of breath alcohol tester" administered by a "trained observer." The specific qualifications of this "trained observer" are not detailed, but it implies a professional certified to operate such devices.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" was established by an independent, professional breath alcohol tester. The Protocol device's readings were then compared to these objective measurements. There was no expert consensus adjudication as is common in image-based AI studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was done. This device is a standalone breath alcohol checker and does not involve human readers interpreting results in the same way as, for example, a medical imaging AI. The "clinical trial" focused on the user's ability to operate the device and its comparability to professional instruments, not on augmenting human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The "clinical trial" evaluated the Protocol Alcohol Breath Checker's performance as a standalone device. Its semi-quantitative readings (Red/Yellow/Green LEDs) were compared directly to the quantitative results from an "evidentiary type of breath alcohol tester." The user interaction involved reading instructions and operating the device, but the device itself produced an output (LEDs) based on its internal algorithm without further human interpretation beyond understanding the LED codes.

7. The Type of Ground Truth Used

The ground truth used was objective measurements from an "evidentiary type of breath alcohol tester." This can be considered gold- standard instrumentation data for Blood Alcohol Concentration.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. The information provided is for a 510(k) submission, showcasing the performance of the final device, not details on its development or training if it involved machine learning (which is not indicated for this type of sensor-based device). The "calibration" mentioned for the device itself (using 0.05 and 0.08 BAC solutions in the factory) is a manufacturing step, not a "training set" in the machine learning sense.

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

As mentioned above, the concept of a "training set" with ground truth in the machine learning context is not applicable here. The device's underlying sensor technology relies on established physical principles and is calibrated with known alcohol solutions during manufacturing (0.05 and 0.08 BAC solutions). This calibration process ensures the device accurately responds to specific alcohol concentrations.

Summary

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DEC 1 9 2008

EXHIBIT 2

510(k) Summary for K082086 The Ashley Collection Inc. dba PROTOCOL 600 West 57th St. 2nd Floor New York, NY 10019 Tel 212-247-7294 Fax 212-247-1489 Contact: Robert Goldy, CEO Date prepared: November 13, 2008

1. Identification of the Device: Proprietary-Trade Name: Protocol Alcohol Breath Checker Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
1. Equivalent legally marketed devices K052448, Connectables Pocket Breathalyzer
1. Indications for Use (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.
1. Description of the Device: Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC < 0.05. The device also includes a flashlight function and a count-up/count-down timer. The timer can be used for parking meter timing or for timing the wait before performing the alcohol test after consuming alcohol, nominally 20 minutes.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, laboratory and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester.

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6. Substantial Equivalence Chart

Feature	K052448, Connectables PocketBreathalyzer	Protocol Alcohol BreathChecker
INDICATION OF USE	The Connectables PocketBreathalyzer is intended tomeasure alcohol in human breath.Measurements obtained by thisdevice are used in the diagnosis ofalcohol intoxication.	This device is intended to measurealcohol in human breath.Measurements obtained by thisdevice are used in the diagnosis ofalcohol intoxication. (SAME)
MODE	Breath Alcohol Concentration	SAME
PRACTITIONER USE	Over the Counter	SAME
Blowing time	3 Seconds	3 Seconds (SAME)
DISPLAY	Three colored LEDs:Red, Yellow, Green.	SAME
Display Interpretation	Red: BAC > 0.08Yellow: BAC 0.04 to 0.08Green: BAC < 0.04	Red & Yellow BAC 0.08 or moreYellow: BAC 0.05 to 0.08Green: BAC < 0.05
POWER SOURCE	2- AAA Alkaline	SAME
BATTERY LIFE	400 Tests	300 Tests
Measurement Range	0.00-0.40% BAC	SAME
Accuracy	+/-0.01%	SAME
TYPE OF SENSOR	Semiconductor-Oxide Sensor	SAME
ANATOMICAL SITE	Mouth	SAME
Warm Up Time	5-15 seconds	SAME
Construction	Plastic case with internal circuitboard	SAME
SIZE	1.64" x 2.1"	1.5" x 3"
WEIGHT	42 gm	51 gm.
Flashlight	YES	YES
Timer	NO	Count-up or Count-down

7. Conclusion

After analyzing bench tests, EMC, and user testing data, it is the conclusion of Protocol that the Protocol Alcoho! Breathalyzer is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The clinical trial performed 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 provided by a professional unit administered by a trained observer.

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When the batteries are low, the Red and Yellow LEDs may light up during the alcohol test. Replace the batteries at this point.Don't use the light during an alcohol test.See Warnings regarding device replacement.				DON'T DRINK AND DRIVE!the green light is lit.Warnings
Using Alcohol Tester				Our testing has shown that this device functions accurately for at least 400 tests. Based on NIAAA studies, (www.alcoholism.about.com) this corresponds to approximately one year of device use for most drinkers. YOU SHOULD REPLACE YOUR DEVICE ONE YEAR AFTER FIRST USE. FAILURE TO DO SO MAY CAUSE YOUR READINGS TO BE INACCURATE. If you are a heavy drinker or a heavy smoker, we strongly recommend replacing the unit sooner.
WAIT 15 to 20 minutes after drinking alcohol. Alcohol in your mouth could give you an abnormally high reading.				The Alcohol Tester" does not guarantee 100% accuracy or the same results of the breathalyzers used by law enforcement officials. Test results are guides only and should not be relied upon. Results can be affected by environmental conditions, direct sunlight, excessive heat, submersion in liquids, improper usage, and elapsed time after drinking, amount of food consumption, medication and other drugs consumed. It is strongly advised that no motor vehicle or equipment be used after consuming any amount of alcohol, regardless of the results of the Alcohol Tester. The Alcohol Tester uses a colored LED indicator system (Green, Yellow, and Red) to deliver test results. Results should not be interpreted by individuals who are colorblind or visually impaired.
Press and hold the POWER button until just the green LED is lit. When just the green LED is lit, the unit is ready for testing. Hold the power button continuously during and after the testing.				Specifications
Take a deep breath and exhale into the sensor at top of unit for 3 seconds slowly and consistently. The test results will occur immediately. Do NOT touch the top of the unit with your lips.				Test Method: Product uses a semi-conductor gas sensor to detect alcohol on breath and converts it to a BAC level.Preheat time: 5 to 15 seconds (unless the Alcohol Tester was just used)
Observe which LEDs appear. See the chart below for the LED codes.				Battery life: About 200 tests with two "AAA" alkaline batteriesCalibration: Breath alcohol simulator with 0.05 and 0.08 BAC solution, done in factory at time of manufactureDevice life: One year, approximately 400 tests.Operating temperature: 10 to 40°CStorage temperature: 0 to 50°C
Replace unit after one year. See WarningsWait 15-20 seconds before running the test again				Other Functions
		What the LEDs mean:		Light Function
REDandYELLOW	Image: Red and Yellow LED	BAC of.08%orgreater	LEGALLYINTOXICATED.	Set the light switch to position to turn on the light. Do not use the light while using the alcohol tester.
YELLOW	Image: Yellow LED	BAC of.05%to.08%	CAUTION:BORDERLINEINTOXICATED.	Count-up timer
GREEN	Image: Green LED	BAC oflessthan.05%	LOW orMODERATE LEVELBUT YOURDRIVING MIGHTSTILL BEIMPAIRED	1. Press the START/STOP button to start the count-up timer when the setting is 0:002. Press the START/STOP button again to stop the count-up timer.3. To reset the count-up timer to 0:00, press the HR and MIN buttons at the same time.
NoLights	Image: No Lights		Replace the batteries	Countdown timer
"BAC" means "Blood Alcohol Concentration"				1. Press HR or MIN buttons to set the countdown HOUR or MINUTE.2. Press the START/STOP button to start the countdown timer.3. Press the START/STOP button again to stop the countdown timer.4. A two second warning signal will be given at the last 10 and 5 minutes.5. The alarm of the countdown timer lasts 60 seconds.Pressing the HR and MIN buttons at the same time can stop the alarm earlier.6. To reset the countdown timer to 0:00 press the HR and MIN buttons at the same time.
CAUTION: Your driving may be impaired at ANY level. This may be true even if only

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol to the right, resembling a person with outstretched arms. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Ashley Collection, Inc. Attn: Mr. Robert Goldy 600 West 57th St., 2nd Floor New York, NY 10019

DEC 1 9 2008

Re: K082086

Trade Name: Protocol Alcohol Breath Alcohol Tester Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: November 14, 2008 Reccived: November 17, 2008

Dear Mr. Goldy:

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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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Indications for Use

K082086 510(k) Number:

Device Name: Alcohol Breath Tester

Indications for Use:

This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.

Prescription Use: (Part 21 CFR 801 Subpart D) and/or

Over-the-Counter Use (OTC):x (21 CFR 807 Subpart C)

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

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

Division Sign-Off Office of In Vitro Diagnostic Devices, Evaluation and Safety 510(k) No. K082086

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.