The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.

Device Description

The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors.

The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO 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. 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.

When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected.

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 BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.

AI/ML Overview

Here's an analysis of the provided information regarding the BreathScan®PRO device, focusing on acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for parameters like accuracy, precision, or false positive/negative rates prior to presenting the study results. Instead, it implies a comparison to a predicate device (Breath Alcohol .02 Detection System K062971) and an evidentiary breath test (ALCO SENSOR IV).

However, the study results themselves can be interpreted as demonstrating the device's performance against an implicit standard set by the comparator device. The document also mentions meeting DOT/NHTSA guidelines as an acceptance benchmark.

Implicit Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Quantitative Correlation with Evidentiary Breath Test	Correlation: The scatter plot (Image /page/2/Figure/1) shows a regression line of y = 0.8579x + 0.0042 with an R-squared value of 0.8447 when comparing the BreathScan®PRO (BSPro) to an Evidentiary Breath Test (Alco-Sensor IV). Standard Error: 0.01
Compliance with DOT/NHTSA Model Specifications	The BreathScan®PRO was evaluated and found to meet the guidelines provided in the DOT/NHTSA Model Specifications for Alcohol Screening Devices (Federal Register/Vol. 73, No. 62, March 31, 2008/Notices/16956). (Specific performance metrics against these guidelines are not provided in this document).
Equivalence to Predicate Device (Breath Alcohol .02 Detection System K062971)	Indications for Use: Both detect alcohol in human breath. Target Populations: Both Over the Counter. Result Type: Predicate is qualitative (Red/Green LEDs), BreathScan®PRO is quantitative (digital readout). This is a difference, not a direct performance comparison, but implies the BreathScan®PRO offers a more detailed result. Accuracy/Calibration: Neither requires calibration. Other differences: Measurement range, display type, physical characteristics, power source, battery life (BreathScan®PRO has longer battery life). These are characteristics, not direct performance metrics of accuracy or precision.
Safe and Effective as an Evidentiary Breath Test	Bench test and user testing data indicated the BreathScan®PRO is safe and effective as an evidentiary breath test.
User Comprehension and Proper Use	User studies were performed to establish that the user could read and understand the directions provided and properly use the devices, obtaining results comparable to a predicate device administered by a trained technician. (Specific metrics for user comprehension are not provided in this document).

Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The key study presented is a comparison of the BreathScan®PRO against the ALCO SENSOR IV, which is described as an "Evidentiary Breath Test" and a "DOT/NHTSA approved device."

The study is described as:

Bench test and user testing data for safety and effectiveness.
A comparison to the Evidentiary Breath Test (Alco-Sensor IV), the results of which are depicted in the scatter plot.
User studies to assess user comprehension and proper usage, obtaining comparable results to a predicate device.

2. Sample Size and Data Provenance

Test Set Sample Size: 62 total subjects were used for the comparison study with the Alco-Sensor IV.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective as it involves user testing and data collection for comparison.

3. Number of Experts and Qualifications for Ground Truth

The document mentions comparison to the ALCO SENSOR IV, which is an "Evidentiary Breath Test" and a "DOT/NHTSA approved device." The results from this device are essentially considered the ground truth for the quantitative comparison.
It also states that user studies obtained results "comparable to those provided by a predicate device administered by a trained technician." While not directly defining the ground truth for measurement, this implies the benchmark performance of the predicate device under expert operation.
The number of "experts" (or trained technicians operating the Alco-Sensor IV) is not specified. Their specific qualifications (e.g., years of experience) are also not specified beyond "trained technician."

4. Adjudication Method

The document does not describe an adjudication method (e.g., 2+1, 3+1) for establishing ground truth. The Alco-Sensor IV appears to be the single source of ground truth for BAC measurements.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study focuses on comparing the device's readings to an evidentiary breath test and assessing user performance, not on how human readers' diagnostic accuracy improves with or without AI assistance. The BreathScan®PRO is a standalone device with a digital readout, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was done. The core "bench test" and "user testing data" with the comparison to the Alco-Sensor IV evaluates the algorithm's (device's) performance in generating the quantitative digital readout of BAC. The digital readout is inherently the algorithm's output.

7. Type of Ground Truth Used

The primary ground truth used for quantitative comparison was the readout from a legally recognized evidentiary breath test device (ALCO SENSOR IV). This is a form of device-based ground truth using a gold-standard instrument.
For the user studies, the ground truth was implied to be the results obtained by a trained technician operating a predicate device, which served as the benchmark for comparison of user-obtained results.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This is a device for detecting alcohol in breath, not typically an AI/ML model that undergoes a distinct training phase in the same way. The device is factory pre-calibrated.

9. How Ground Truth for the Training Set Was Established

As a factory pre-calibrated device rather than a machine learning model, the concept of a "training set" and establishing ground truth for it in the typical AI context does not apply directly. The document states the electronic Analyzer is "factory pre-calibrated." The methods for this pre-calibration and the ground truth used during that calibration are not detailed in the provided text.

Summary

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K102338

SECTION 5. 510(k) SUMMARY

JAN 1 2 2011

5.1 Date: August 13, 2010

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:

	BreathScan®PRO
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®PRO is equivalent to: Breath Alcohol .02 Detection System manufactured by ABI (K062971)

5.5 Indications for Use

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5.6 Description of the device

Safety and Effectiveness 5.7

The bench test and user testing data indicated that the BreathScan PRO is 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 (Table 1).

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

Image /page/2/Figure/1 description: This image is a scatter plot with a regression line. The x-axis is labeled "Evidentiary" and ranges from 0 to 0.2, while the y-axis is labeled "BSPro" and ranges from 0 to 0.18. The plot contains numerous data points scattered around a regression line, which is described by the equation y = 0.8579x + 0.0042, with an R-squared value of 0.8447. The title of the plot indicates that there are 62 total subjects.

Standard Error = 0.01

Additionally, the BreathScan®PRO was evaluated and found to meet the guidelines provided in the DOT/NHTSA Model Specifications for Alcohol Screening Devices -(Federal Register/Vol. 73, No. 62, March 31, 2008/Notices/16956).

5.8 Substantial Equivalence

The similarities and differences between the BreathScan®PRO and the Breath Alcohol .02 Detection System is summarized in Table 2.

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Table 2

Similarities and Difference Between the BreathScan®PRO and the Breath Alcohol .02 Detection System

SIMILARITIES
Parameter	Device	Predicate Device
	BreathScan®PRO	Breath Alcohol®.02Detection SystemK062971
Indications for Use	Detect the presence ofalcohol in human breath.	Detect the presence of alcoholin human breath.
Target Populations	Over the Counter	Over the Counter
Display	Digital Read out	Red, Green LEDs
Calibration/AccuracyChecks	None required	None required
Result	Quantitative	Qualitative
Construction	Plastic case with internalcircuit board	Plastic case with internalcircuit board

DIFFERENCES
Parameter	Device	Predicate Devices
Test Sample	BreathScan®PRO	Breath Alcohol ☑ ®.02Detector charged withhuman breath
Mouthpiece	None required	None required
Anatomical Site	Mouth	Mouth
Instrument System	Reflectance Measurement	Reflectance Measurement
Measurement Range	Defined limits, 0.00% to0.15% (higher levelsdisplayed as >0.15%)BAC	Defined limits, <.02% =Green flashing LED(negative) and ≥.02% Redflashing LED (positive)
Warm Up Time	None	None
Dimensions	5 ½ by 4 1/8 inches	2 by 3 3/8 inches
Weight	250 grams	75 grams
Battery Life	2000 measurements	1000 measurements
Power Source	1Lithium 9 volt (built in)	2- CR2032 batteries (builtin)

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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®PRO 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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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of a human figure with three heads, representing the department's focus on health, well-being, and human services. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Akers Biosciences, Inc. c/o Barbara Bagby 201 Grove RD. Thorofare, NJ 08086

Re: K102338 Trade/Device Name: BreathScan Pro

Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I, reserved Product Code: DJZ Dated: December 23, 2010 Received: December 27, 2010

JAN 1 2 291

Dear Ms. Bagby:

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 3.0(K) premation is substantially equivalent (for
device referenced above and have determined the lawlers and device referenced above and have determined the enclosure) to legally marked predicate devices
the indications for use stated in the enclosure) to legally marked predicate of the indications for use stated in the enclosure, as 1976, the enactment date of the marketed in interstate comments, or to devices that have been reclassified in accordance
Medical Device Amendments, or to devices that have been reclassified in accordance Medical Device Amendments, of to devices man mave over in Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) the with the provisions of the Federal Pood, Drug, and Cosmons (Perefore, market the
approval of a premarket approval application (PMA). You may, therefore, market the approval of a premarket approval appricanton (rimal). The general controls
device, subject to the general controls provisions of the Act. The general controls device, subject to the general controls for annual registration, listing of devices,
provisions of the Act include requirements for annual registrating and provisions of the Act include requirements for amidal regioned of the Actives, and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (special Controls) on class III ( If your device is classified (see above) into ennerols. Existing major regulations
(PMA), it may be subject to such additional controls. Existing major regulations (CFF (PMA), it may be subject to such additional colling indials and one and the many of the mails
affecting your device can be found in Title 21, Code of Federal Regulations your affecting your device can be found in Thie 21, Code of February of the device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does
s with the states and such tempination that your device complies with other Please be advised that FDA's issuance of a substance class of the complies with other
not mean that FDA has made a determination that your device saministered by oth not mean that FDA has made a determination inaryour administered by other
requirements of the Act or any Federal statutes and regulations administered by other requirements of the Act or any Federal statules and reguliements, noluding, but not
Federal agencies. You must comply with all the Act 's requirements, not and Federal agencies. You must comply with all the Act 3 reqise of 21 CFR Parts 801 and limited to: registration and listing (21 CPK Pall of 7 medical device-related adverse events) (21
809); medical device reporting (reporting of medical device-related adverse 809); medical device reporting (reporting of medical device requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in th CFR 805), and good ion (21 CFR Part 820).

1999 1999 1999

and the control control control controlled in the controlled

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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.

Courthey 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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Indications for Use Form

JAN 12 2011

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The BreathScan®PRO is an in vitro medical device that quantitatively . the presence of alcohol in the human breath. The device is used only as a screening device and is an indication of the possible presence of alcohol in the blood of the test subject.

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 of Office of Landfill

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

510(k) K/02338

Page 1 of / _

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.