BREATHSCN PRO

K102338 · Akers Biosciences, Inc. · DJZ · Jan 12, 2011 · Clinical Toxicology

Device Facts

• Record ID: K102338
• Device Name: BREATHSCN PRO
• Applicant: Akers Biosciences, Inc.
• Product Code: DJZ · Clinical Toxicology
• Decision Date: Jan 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3050
• Device Class: Class 1

Indications for Use

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 Story

BreathScan PRO is an OTC electronic breath-alcohol screening device. User exhales into a disposable detector containing light-yellow crystals; crystals change color (yellow to blue-green) upon exposure to alcohol vapor. The electronic analyzer uses reflectance measurement to interpret the color change of the detector. Device provides a digital readout of BAC from 0.00% to 0.15% (levels >0.15% displayed as >0.15%). Device is factory pre-calibrated; requires no warm-up. Used by consumers for personal screening. Output provides an indication of potential blood alcohol presence, assisting users in monitoring alcohol levels. Benefits include rapid, non-invasive, quantitative screening without requiring professional administration.

Clinical Evidence

Bench testing and user studies performed. User study (n=62) compared BreathScan PRO results against an evidentiary breath test (Alco-Sensor IV). Regression analysis showed y = 0.8579x + 0.0042 with R-squared = 0.8447 and standard error of 0.01. Device met DOT/NHTSA Model Specifications for Alcohol Screening Devices.

Technological Characteristics

Plastic housing with internal circuit board. Sensing principle: Reflectance measurement of disposable detector containing alcohol-sensitive crystals (yellow to blue-green color change). Power: 9V lithium battery. Dimensions: 5.5 x 4.125 inches. Weight: 250g. Standalone operation; no connectivity. Factory pre-calibrated.

Indications for Use

Indicated for OTC quantitative screening of alcohol in human breath to estimate blood alcohol concentration (BAC). Intended for use by general population as a screening tool; not for evidentiary use.

Regulatory Classification

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.

Predicate Devices

• Breath Alcohol .02 Detection System (K062971)

Reference Devices

• ALCO SENSOR IV (Evidentiary Breath Measurement Device)

Submission Summary (Full Text)

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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

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.

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#### 5.6 Description of the device

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.

#### 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®.02<br>Detection System<br>K062971 |
| Indications for Use | Detect the presence of<br>alcohol in human breath. | Detect the presence of alcohol<br>in human breath. |
| Target Populations | Over the Counter | Over the Counter |
| Display | Digital Read out | Red, Green LEDs |
| Calibration/Accuracy<br>Checks | None required | None required |
| Result | Quantitative | Qualitative |
| Construction | Plastic case with internal<br>circuit board | Plastic case with internal<br>circuit board |

| <i>DIFFERENCES</i> | | |
|--------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Parameter | Device | Predicate Devices |
| Test Sample | BreathScan®PRO | Breath Alcohol <span style="text-decoration: overline;">☑</span> ®.02<br>Detector charged with<br>human breath |
| Mouthpiece | None required | None required |
| Anatomical Site | Mouth | Mouth |
| Instrument System | Reflectance Measurement | Reflectance Measurement |
| Measurement Range | Defined limits, 0.00% to<br>0.15% (higher levels<br>displayed as >0.15%)<br>BAC | Defined limits, <.02% =<br>Green flashing LED<br>(negative) and ≥.02% Red<br>flashing 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 (built<br>in) |

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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 [phone]. 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 [phone] or [phone] 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

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