The BreathScan® 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 at several detection cut-offs; 0.02, 0.04, 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. BreathScan is not intended to legally determine blood alcohol presence, level, or inference of intoxication.

Device Description

The BreathScan® Alcohol Detector (Tester) is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (4,740,475). The Tester is made up of a 2-part glass vessel inside a plastic tube. One part contains light 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 light green/blue. 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 in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). 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 [Cr2(SO4)3]. The majority of crystals change from vellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BreathScan® Alcohol Detector, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text indicates that the BreathScan® Alcohol Detector was evaluated against the guidelines of the DOT/NHTSA Model Specifications for Alcohol Screening Devices. While specific numerical acceptance criteria from the DOT/NHTSA Model Specifications are not explicitly stated in the document, the device's performance is compared to a predicate device (ALCO SENSOR IV) and is assessed for user readability and usability.

Implicit Acceptance Criteria (derived from the text):

Accuracy against a standard: Performance should be comparable to or meet the guidelines of validated evidentiary breath tests (like ALCO SENSOR IV) and DOT/NHTSA Model Specifications.
User Usability: Users should be able to read and understand directions and properly use the device.
Low False Positives: The device should have a low rate of false positive readings when no alcohol is present.

Here's a table summarizing the observed performance for the 0.04% BreathScan® Tester:

BreathScan® 0.04% Tester Result	Predicate Results (ALCO SENSOR IV) Groupings	Reported Device Performance	Comments
Positive	Less than 60% below Cutoff (<0.016%)	0	The device correctly reported 0 positives for samples below the cutoff, indicating good specificity at this low range.
Positive	Near Cut-off Negative (0.016 to 0.040%)	0	The device correctly reported 0 positives for samples below the cutoff, indicating good specificity in the negative range near the cutoff.
Positive	Near Cut-off Positive (>0.040 to 0.064%)	15	The device reported 15 positives in this range. The table seems to indicate these are "true positives" relative to the predicate's categorization for results above the cutoff.
Positive	High Positive (>0.064%)	10	The device reported 10 positives in this high range. These are "true positives" relative to the predicate.
Negative	Less than 60% below Cutoff (<0.016%)	37	The device correctly reported 37 negatives for samples below the cutoff, supporting specificity.
Negative	Near Cut-off Negative (0.016 to 0.040%)	25	The device correctly reported 25 negatives for samples in this range, supporting correct negative identification below the cutoff.
Negative	Near Cut-off Positive (>0.040 to 0.064%)	5	This indicates 5 false negatives. The predicate device showed these as positive, but the BreathScan® reported them as negative.
Negative	High Positive (>0.064%)	1	This indicates 1 false negative. The predicate device showed this as positive, but the BreathScan® reported it as negative.

Additional Performance Metric:

False Positives (without alcohol): 1 false positive reading out of 1200 readings (for the 0.04% tester) that did not contain alcohol. This indicates a very low rate of false positives when no alcohol is present.

2. Sample Size and Data Provenance

Test Set Sample Size:
- For the comparison study with the Alco-Sensor IV: The numbers in Table 1 sum to 93 test cases (0+0+15+10+37+25+5+1 = 93) for the 0.04% tester's comparison to the predicate device.
- For the false positive evaluation: 1200 readings of the 0.04% tester did not contain alcohol.
Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be prospective as it involves "user studies" and "bench testing" performed to establish device performance.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

Number of Experts: Not specified.
Qualifications of Experts: The ground truth comes from an "evidentiary breath test, the ALCO SENSOR IV manufactured by Intoximeters, Inc. which is a DOT/NHTSA approved device." It also mentions it was "administered by a trained technician." While not "experts" in the sense of medical specialists, the ground truth is established by a validated, approved device and trained personnel.

4. Adjudication Method for the Test Set

The adjudication method wasn't explicitly described in terms of "2+1" or "3+1." The comparison relies on a single predicate device (ALCO SENSOR IV) as the reference standard. The results from the BreathScan® are then compared directly to the categorization provided by the ALCO SENSOR IV.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted as described (i.e., comparing human readers with and without AI assistance). The "user studies" mentioned focus on the user's ability to read directions and use the device, not on improving human reader performance with AI. The device itself is a standalone qualitative test.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done. The BreathScan® Alcohol Detector is a standalone device that provides a qualitative visual result (color change) without human interpretation beyond observing the color. The "bench and user testing" results, particularly the comparison to the Alco-Sensor IV and the false positive rate evaluation, represent a standalone performance assessment of the device itself.

7. Type of Ground Truth Used (for Test Set)

The primary ground truth used for the test set was:

Comparison to an Evidentiary Breath Test: The ALCO SENSOR IV, a DOT/NHTSA approved device, served as the reference standard for actual breath alcohol concentrations.
Known Alcohol Content: For the false positive evaluation, the "1200 readings... that did not contain alcohol" indicates controlled samples with known negative alcohol content.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. This type of device (chemical reaction-based) typically does not involve machine learning or an explicit "training phase" in the way an AI algorithm would. Its development likely involved calibration and validation against known alcohol concentrations in a lab setting during its design and manufacturing, rather than a data-driven training set for an algorithm.

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

Since a "training set" for an AI algorithm is not applicable, the concept of establishing ground truth for it is also not applicable here. The device's calibration and performance were likely established through engineering and chemical validation against known concentrations of alcohol and performance testing against established standards (e.g., DOT/NHTSA).

Summary

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250 28 2002

SECTION 5. 510(k) SUMMARY STATEMENT

5.1 Date: April 25, 2006

5.2 Submitter:

Name: Akers Biosciences, Inc

Address: 201 Grove Road

Thorofare, New Jersey, 08086

Telephone: 856-848-8698

Contact: Barbara Bagby

5.3 Device:

Trade or Proprietary Name: BreathScan® Alcohol Detector.

02, . 04, . 05 and .08% BAC Sensitivity Cut-Offs

Other Brand Names: Biotech Redwood, EZ Screen, Alco Limit, and Breath Alcohol

Common or usual Name: Breath-alcohol test

Classification Name: Devices, Breath Trapping, Alcohol

Product Code: DJZ

Regulation Number: 862,3050

5.4 Predicate Device:

BreathScan is equivalent to: CONNECTABLES® Alcohol Tester manufactured by Connectables, LLC in Waukegan, IL (K052448).

ર્સ્ડ Indications for Use

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5.6 Description of the device

If alcohol is present, the crystals will change from yellow to light green/blue. 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 in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). 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 [Cr2(SO4)3]. The majority of crystals change from vellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester.

The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

5.7 Safety and Effectiveness

The results of bench and user testing indicates that the new device is as safe and effective as an evidentiary breath test, the ALCO SENSOR IV manufactured by Intoximeters, Inc. which is a DOT/NHTSA approved device (Conforming Products List of Evidentiary Breath Measurement Devices - FR/Vol.69, No.134/July 2004/Notices/42237. Multiple user studies were performed to establish that the user could read and understand the directions provided and properly use the device (Table 1).

BreathScan®.04% TesterResult	Predicate Results
Less than 60%below the Cutoff(< 0.016%)	Near Cut-offNegative(0.016 to 0.040%)	Near Cut-offPositive(>0.040 to 0.064%)	HighPositive(> 0.064%)
Positive	0	0	15	10
Negative	37	25	5	1

Table 1 Comparison to Evidentiary Breath Test (Alco-Sensor IV)

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Additionally, the BreathScan® Alcohol Detector was evaluated and found to meet the guidelines provided in the DOT/NHTSA Model Specifications for Alcohol Screening Devices -(Federal Register/ Vol. 59, No. 147, August 2, 1994 / Notices/39382) with one exception. This exception was that 1 false positive reading out of 1200 readings of the .04 tester that did not contain alcohol.

5.8 Substantial Equivalence

SIMILARITIES
Parameter	BreathScan®	CONNECTABLES®
Indications for Use	Detect the presence of alcohol in the human breath.	Detect the presence of alcohol in the human breath.
Target Populations	Over the Counter	Over the Counter
Calibration/Accuracy Checks	None required	None required
Anatomical Site	Mouth	Mouth
Test Sample	Human breath	Human breath

Similarities and Differences Between BreathScan® and CONNECTABLES®

DIFFERENCES
Parameter	BreathScan®	CONNECTABLES®
Result	Qualitative	Semi-Quantitative
Interpretation	Visual Color Change	Red, Yellow, and Green LEDs
Instrument system	None	Semiconductor-Oxide Sensor
Measurement Range	Separate devices are pre-calibrated to turn color atdifferent cut-offs: .02%,..04%, .05%, and .08%	Upper limit undefined – anyconcentration greater than0.04% will produce red light
Mouthpiece	None required	Replaceable
Blowing Time	12 seconds	3 seconds
Warm Up Time	None	5-15 seconds
Size	2 ¾ by 1/3 inches	2.1 by 1.64 inches
Weight	1.9067 grams	42 grams
Power Requirement	None	2-AAA alkaline batteries

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5.9 Conclusions

After analyzing bench test and user testing data, it is the conclusion of Akers Biosciences, Inc. that the BreathScan® Alcohol Detector is as safe and effective as the predicate and comparative devices. Users 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 provided by a predicate device administered by a trained technician.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 28 2005

Ms. Barbara Bagby Director Regulatory Affairs Akers BioSciences, Inc. 201 Grove Road Thorofare, NJ 08086

Re: K060761

Trade/Device Name: BreathScan Alcohol Detectors (0.02, 0.04, 0.05 and 0.08% BAC) Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: March 17, 2006 Received: March 22, 2006

Dear Ms. Bagby:

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) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, 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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Indications for Use

510(k) Number (if known): K060761

Device Name:

BreathScan® Alcohol Detector

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Cffcl
Division Sign-Off

Unvision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

K060761

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.