(147 days)
Not Found
No
The device description and performance studies focus on chemical reactions and electronic analysis of breath, with no mention of AI or ML algorithms for data processing or interpretation.
No
Explanation: The device is described as a screening device that detects the presence of alcohol but does not treat or prevent any medical condition.
Yes
The device detects the presence of alcohol in human breath, indicating the presence of alcohol in the blood, which is a diagnostic function for screening purposes.
No
The device description clearly outlines hardware components including an electronic analyzer, disposable detectors with chemicals and a glass capsule, and re-usable blow bags. This indicates it is not a software-only device.
Yes, based on the provided text, the BreathScan PRO is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The BreathScan PRO is an in vitro medical device..."
- Nature of the Test: The device analyzes a biological sample (breath) outside of the body to detect the presence of a substance (alcohol). This is a core characteristic of an in vitro diagnostic test.
- Purpose: The purpose is to provide information about the physiological state of the individual (presence of alcohol in the blood, indicated by breath alcohol).
Therefore, the device clearly fits the definition of an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DJZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Table 1 Comparison to Evidentiary Breath Test (Alco-Sensor IV)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
R-squared value of 0.8447
Standard Error = 0.01
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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).
2
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.
$$\mathcal{S}^{-4}$$
3
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 | |
| Detection System | ||
| K062971 | ||
| Indications for Use | Detect the presence of | |
| alcohol in human breath. | Detect the presence of alcohol | |
| in human breath. | ||
| Target Populations | Over the Counter | Over the Counter |
| Display | Digital Read out | Red, Green LEDs |
| Calibration/Accuracy | ||
| Checks | None required | None required |
| Result | Quantitative | Qualitative |
| Construction | Plastic case with internal | |
| circuit board | Plastic case with internal | |
| circuit board |
| DIFFERENCES | ||
|---|---|---|
| Parameter | Device | Predicate Devices |
| Test Sample | BreathScan®PRO | Breath Alcohol ☑ ®.02 |
| Detector charged with | ||
| human breath | ||
| Mouthpiece | None required | None required |
| Anatomical Site | Mouth | Mouth |
| Instrument System | Reflectance Measurement | Reflectance Measurement |
| Measurement Range | Defined limits, 0.00% to | |
| 0.15% (higher levels | ||
| displayed as >0.15%) | ||
| BAC | Defined limits, |