The Breath Alcohol Z .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system 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 Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are a visual qualitative test for alcohol in the human breath. The Breath Alcohol 20 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System consist of a self-contained electronic analyzer to qualitatively detect the presence of alcohol in the human breath. It is a reusable device designed for use with a specific lot of Breath Alcohol Z . 02 or BreathScan® .02 Detectors. The detectors are disposable screening devices designed for one time use. The Breath Alcohol .02 and BreathScan .02 Electronic Analyzers enable the user to read or interpret their Breath Alcohol 70 .02 or BreathScan® .02 Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.

The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (US Patent No. 4,740,475). The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with 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 Detector and how much alcohol is in the breath.

The yellow crystals in the Detector are coated with potassium dichromate (K2Cr2O7) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Detector. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium suffate [Cr2(SO4)3]. The majority of crystals change from yellow to light aqua (greenish-blue/bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Detector.

The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the Breath Alcohol . 02 Detection System, this is required (DOT/NHTSA compliance) and is listed as an option in the BreathScan® .02 Breath Alcohol Detection System.

The Breath Alcohol Z .02 and BreathScan® .02 Electronic Analyzers are selfcontained, sealed devices where the Breath Alcohol or BreathScan® Detector charged with human breath is inserted into the device to begin the reading process. The internal make-up of the Electronic Analyzer is the same for both models. The only difference is how the detector is positioned or inserted into the device. Using the Breath Alcohol .02 Detection System, the detector is inserted into a sample port; whereas using the BreathScan® .02 Breath Alcohol Detection System, the detector is placed in a nested holder.

The Electronic Analyzer automatically turns on and the lights will flash instantaneously, indicating the respective result. The device comes pre-calibrated to the user for the cut-off sensitivity of the Breath Alcohol 700.02 or BreathScan® .02 Detector lot being "read" in the analyzer. A negative result is indicated by a continuously flashing green LED and a positive result is indicated by a continuously flashing red LED.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's performance against two main types of criteria: comparison to an evidentiary breath test and compliance with DOT/NHTSA guidelines. The tables below summarize the device performance against the stated categories.

Detection System: Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System

Acceptance Criteria Category	Specific Criteria/Reference	Reported Device Performance	Comments
Comparison to Evidentiary Breath Test (Alco-Sensor IV)	Less than 60% below the Cutoff (< 0.008%)	Positive: 0Negative: 22	Device correctly identified all cases below 0.008% as negative.
	Near Cut-off Negative (0.008% to 0.020%)	Positive: 1Negative: 3	One false positive in this range. A 'Negative' result means the device correctly identified it as negative. Given the device targets ≥0.02%, detection of a positive result at 0.008-0.020% signifies a false positive (identifying alcohol when below the threshold).
	Near Cut-off Positive (>0.020% to 0.032%)	Positive: 8Negative: 0	Device correctly identified all cases in this range as positive.
	High Positive (>0.032%)	Positive: 11Negative: 0	Device correctly identified all cases in this range as positive.
DOT/NHTSA Guidelines Compliance	Model Specifications for Alcohol Screening Devices (Federal Register/Vol. 59, No. 147, August 2, 1994/Notices/39382)	"evaluated and found to meet the guidelines"	The document states that the devices met these guidelines, but specific performance metrics against these guidelines are not provided in this summary.
User Understanding and Proper Use	User could read and understand directions and properly use the devices.	User studies were performed to establish this.	The text mentions user studies were performed to establish this, implying this criterion was met, but no specific data or metrics are provided.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
  - For the Breath Alcohol ® .02 Detection System: 22 + 3 + 8 + 11 = 44 cases
  - For the BreathScan® .02 Breath Alcohol Detection System: 22 + 3 + 8 + 11 = 44 cases
  - It appears to be the same set of 44 cases for both devices, as the performance numbers are identical in Table 1 and Table 2.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "bench test and user testing data," which typically implies a prospective study conducted specifically for validation.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The ground truth was established by comparison to an "Evidentiary Breath Test (Alco-Sensor IV)," which is described as a "DOT/NHTSA approved device." This reference device acts as the "gold standard" or ground truth. The study does not mention human experts establishing ground truth for the alcohol levels themselves, but rather relies on the measurement from the Alco-Sensor IV.
Adjudication Method for the Test Set:
- No adjudication method is mentioned in the context of resolving discrepancies between multiple readers or ground truth. The comparison is directly between the investigational device's reading and the "Evidentiary Breath Test" (Alco-Sensor IV) result.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone detection system, not an AI-assisted diagnostic tool for human interpretation.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance presented in Tables 1 and 2 appears to be a standalone (algorithm only) performance. The "Electronic Analyzer" automatically turns on and the lights flash indicating the result ("continuously flashing green LED" for negative, "continuously flashing red LED" for positive). There is no mention of human interpretation influencing the final reported result from the device itself for these comparison tests. User studies were performed to ensure proper device use, but the device's output is automatic.
Type of Ground Truth Used:
- The ground truth used was comparison to a reference device, specifically the "Evidentiary Breath Test (Alco-Sensor IV)." The Alco-Sensor IV is considered a "DOT/NHTSA approved device," implying it is a validated and accepted method for determining breath alcohol concentration.
Sample Size for the Training Set:
- The document does not provide information regarding a separate training set or its sample size. This type of device, based on a chemical reaction read by an electronic analyzer, typically undergoes calibration during manufacturing rather than machine learning training. The device "comes pre-calibrated... for the cut-off sensitivity."
How the Ground Truth for the Training Set Was Established:
- As no training set is explicitly mentioned in the provided text for a machine learning context, the method for establishing its ground truth is not applicable or not provided. The device's calibration is mentioned, which would involve setting its sensitivity against known alcohol standards.

Summary

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K062971

SECTION 5. 510(k) SUMMAR Y

5.1 Date: September 28, 2006

5.2 Submitter:

Name:	Akers Biosciences, Inc
Address:	201 Grove Road
	Thorofare, New Jersey, 08086
Telephone:	856-848-8698
Contact:	Barbara A. Bagby

5.3 Device:

Trade or Proprietary Name:

	Breath Alcohol ✔ ®.02 Detection System
	BreathScan® .02 Breath Alcohol Detection System
Common or usual Name:	Breath-alcohol test
Classification Name:	Devices, Breath Trapping, Alcohol
Product Code:	DJZ
Regulation Number:	862.3050

5.4 Predicate Device:

Breath Alcohol 7.02 Detection System and BreathScan®.02 Breath Alcohol Detection System are equivalent to: CONNECTABLES® Alcohol Tester manufactured by Connectables, LLC in Waukegan, IL (K052448).

ર્સ્ડ Indications for Use

The Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system 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.

DEC 1 8 2006

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5.6 Description of the device

The Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are a visual qualitative test for alcohol in the human The Breath Alcohol 20 .02 Detection System and BreathScan® .02 breath. Breath Alcohol Detection System consist of a self-contained electronic analyzer to qualitatively detect the presence of alcohol in the human breath. It is a reusable device designed for use with a specific lot of Breath Alcohol Z . 02 or BreathScan® .02 Detectors. The detectors are disposable screening devices designed for one time use. The Breath Alcohol .02 and BreathScan .02 Electronic Analyzers enable the user to read or interpret their Breath Alcohol 70 .02 or BreathScan® .02 Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.

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 Detector and how much alcohol is in the breath.

The Breath Alcohol Z .02 and BreathScan® .02 Electronic Analyzers are selfcontained, sealed devices where the Breath Alcohol or BreathScan® Detector charged with human breath is inserted into the device to begin the reading process. The internal make-up of the Electronic Analyzer is the same for both models. The only difference is how the detector is positioned or inserted into the Using the Breath Alcohol .02 Detection System, the detector is device. inserted into a sample port; whereas using the BreathScan® .02 Breath Alcohol Detection System, the detector is placed in a nested holder.

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5.7 Safety and Effectiveness

The bench test and user testing data indicated that the Breath Alcohol 200 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are 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).

User studies were performed to establish that the user could read and understand the directions provided and properly use the devices (Tables 1 and 2).

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

Breath Alcohol ® .02Detection SystemResult	Less than 60%below the Cutoff(< 0.008%)	Near Cut-offNegative(0.008 to 0.020%)	Near Cut-offPositive(>0.020 to 0.032%)	HighPositive(>0.032%)
Positive	0	1	8	11
Negative	22	3	0	0

Table 2
Comparison to Evidentiary Breath Test (Alco-Sensor IV)

	Evidentiary Breath Test Results
BreathScan®.02 BreathAlcohol DetectionSystemResult	Less than 60%below the Cutoff< 0.008%)	Near Cut-offNegative(0.008 to 0.020%)	Near Cut-offPositive(>0.020 to 0.032%)	HighPositive(> 0.032%)
Positive	0	1	8	11
Negative	22	3	0	0

Additionally, the Breath Alcohol . 02 Detection System and BreathScan® .02 Breath Alcohol Detection System were 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).

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5.8 Substantial Equivalence

The similarities and differences between the Breath Alcohol █® .02 Detection System and BreathScan® .02 Breath Alcohol Detection System and the Connectables® Alcohol Tester (predicate device) are summarized in Tables 3 and 4.

Table 3

Similarities and Difference Between Breath Alcohol 70 .02 Detection System and CONNECTABLES®

SIMILARITIES
Parameter	Device	Predicate
	Breath Alcohol Detection System	CONNECTABLES®Alcohol TesterK052448
Indications for Use	Detect the presence of alcohol inhuman breath.	Detect the presence of alcohol inhuman breath.
Target Populations	Over the Counter	Over the Counter
Display	Red, Green LEDs	Red, Yellow, Green LEDs
Calibration/AccuracyChecks	None required	None required
Result	Qualitative	Semi-Quantitative
Construction	Plastic case with internal circuitboard	Plastic case with internal circuitboard

DIFFERENCES
Parameter	Device	Predicate
Test Sample	Breath Alcohol ✔® .02 Detectorcharged with human breath	Human Breath
Mouthpiece	None required	Replaceable
Anatomical Site	None	Mouth
Instrument System	Reflectance Measurement	Semiconductor-Oxide Sensor
Measurement Range	Defined limits, <.02% = Greenflashing LED (negative) and≥.02% Red flashing LED (positive)	Upper limit undefined - anyconcentration greater than .04%will produce red light
Warm Up Time	None	5-15 seconds
Dimensions	2 by 3 3/8 inches	2.1 by 1.64 inches
Weight	75 grams	42 grams
Battery Life	1000 measurements	400 measurements
Power Source	2- CR2032 batteries (built in)	2-AAA alkaline batteries

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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 three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

· Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Barbara A. Bagby Akers Biosciences, Inc. 201 Grove Road Thorofare, NJ 08086

DEC 1 8 2006

K062971 Trade/Device Name: Breath Alcohol V .02 Detection System BreathScan® .02 Breath Alcohol Detection System Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I, reserved Product Code: DJZ Dated: September 28, 2006 Received: September 29, 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 Guts

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): K062971

Breath Alcohol 70 .02 Detection System Device Name: BreathScan® .02 Breath Alcohol Detection System

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 IF NEEDED)

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

Sign-Off

Office of In Vitro Diagnostic Device tion and Safety

Page 1 of 1

062971

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.