(80 days)
Not Found
No
The device description relies on a chemical reaction and a simple electronic analyzer to interpret the color change. There is no mention of AI, ML, or complex data processing that would suggest the use of such technologies.
No.
The devices are described as "in vitro medical devices that qualitatively detect the presence of alcohol in the human breath" and "only an indication of the possible presence of alcohol in the blood of the test subject," serving as a "screening device" and "safe and effective as an evidentiary breath test." They do not appear to treat or mitigate a disease or condition.
Yes
The device qualitatively detects the presence of alcohol in human breath to indicate the possible presence of alcohol in the blood, which is a diagnostic function for screening purposes.
No
The device description explicitly states it consists of a "self-contained electronic analyzer" and "disposable screening devices" containing chemicals, indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement directly identifies the device as an in vitro medical device, which is the definition of an IVD. The device analyzes a sample (breath) taken from the human body to provide information about a physiological state (presence of alcohol).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
None
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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) 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
1
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.
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 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.
2
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.
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 ® .02
Detection System
Result | Less than 60%
below the Cutoff
(0.020 to 0.032%) | High
Positive
(>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 Breath | ||||
| Alcohol Detection | ||||
| System | ||||
| Result | Less than 60% | |||
| below the Cutoff | ||||
| 0.020 to 0.032%) | High | |||
| Positive | ||||
| (> 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).
3
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 Tester | ||
| K052448 | ||
| 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 | Red, Green LEDs | Red, Yellow, Green LEDs |
| Calibration/Accuracy | ||
| Checks | None required | None required |
| Result | Qualitative | Semi-Quantitative |
| Construction | Plastic case with internal circuit | |
| board | Plastic case with internal circuit | |
| board |
| DIFFERENCES | ||
|---|---|---|
| Parameter | Device | Predicate |
| Test Sample | Breath Alcohol ✔® .02 Detector | |
| charged with human breath | Human Breath | |
| Mouthpiece | None required | Replaceable |
| Anatomical Site | None | Mouth |
| Instrument System | Reflectance Measurement | Semiconductor-Oxide Sensor |
| Measurement Range | Defined limits, |