(38 days)
Not Found
No
The device description details a chemical reaction that produces a visual color change to indicate the presence and level of alcohol. There is no mention of computational analysis, algorithms, or learning processes.
No.
The device is described as an in vitro medical device for qualitatively detecting the presence of alcohol in human breath and is used only as a screening device, not for treatment or therapy.
Yes
The device qualitatively detects the presence of alcohol in human breath to screen for possible presence of alcohol in the blood, which is a diagnostic function.
No
The device description clearly outlines a physical device made of glass and plastic containing chemicals that change color. This is a hardware-based device, not software-only.
Yes, based on the provided information, the BreathScan® Alcohol Detector is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath." This directly identifies it as an in vitro medical device.
- Mechanism of Action: The "Device Description" explains that the device uses chemicals (potassium dichromate and sulfuric acid) that react with alcohol vapors in the breath to produce a color change. This is a chemical reaction performed outside the body (in vitro) on a sample (breath).
- Sample Type: The device analyzes human breath, which is a biological sample.
Therefore, the device meets the definition of an in vitro diagnostic device as it is intended for use in the examination of specimens derived from the human body (breath) to provide information for diagnostic purposes (detecting the presence of alcohol).
N/A
Intended Use / Indications for Use
The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs; 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device 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. Correlation between breath alcohol content and blood alcohol content depends on many variables. BreathScan is not intended to legally determine blood alcohol presence, level, or inference of intoxication.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The BreathScan® Alcohol Detector (Tester) is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (4,740,475). The Tester is made up of a 2-part glass vessel inside a plastic tube. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part is 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 Tester and how much alcohol is in the breath.
The yellow crystals in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester.
The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
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 Use
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)
Bench and user testing indicates that the new device is as 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. Multiple user studies were performed to establish that the user could read and understand the directions provided and properly use the device (Table 1).
Additionally, the BreathScan® Alcohol Detector was 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) with one exception. This exception was that 1 false positive reading out of 1200 readings of the .04 tester that did not contain alcohol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key results from Table 1, comparing BreathScan® .04% Tester Result to Predicate Results (Alco-Sensor IV):
- Positive BreathScan® result: 0 in
§ 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
250 28 2002
SECTION 5. 510(k) SUMMARY STATEMENT
- 5.1 Date: April 25, 2006
5.2 Submitter:
Name: Akers Biosciences, Inc
Address: 201 Grove Road
Thorofare, New Jersey, 08086
Telephone: 856-848-8698
Contact: Barbara Bagby
5.3 Device:
Trade or Proprietary Name: BreathScan® Alcohol Detector.
02, . 04, . 05 and .08% BAC Sensitivity Cut-Offs
Other Brand Names: Biotech Redwood, EZ Screen, Alco Limit, and Breath Alcohol
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 is equivalent to: CONNECTABLES® Alcohol Tester manufactured by Connectables, LLC in Waukegan, IL (K052448).
ર્સ્ડ Indications for Use
The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs; 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device 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. Correlation between breath alcohol_content and blood alcohol content depends on many variables. BreathScan is not intended to legally determine blood alcohol presence, level, or inference of intoxication.
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5.6 Description of the device
The BreathScan® Alcohol Detector (Tester) is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (4,740,475). The Tester is made up of a 2-part glass vessel inside a plastic tube. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part is 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 Tester and how much alcohol is in the breath.
The yellow crystals in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from vellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester.
The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
5.7 Safety and Effectiveness
The results of bench and user testing indicates that the new device is as 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. Multiple user studies were performed to establish that the user could read and understand the directions provided and properly use the device (Table 1).
| BreathScan®
.04% Tester
| Result | Predicate Results | |||
|---|---|---|---|---|
| Less than 60% | ||||
| below the Cutoff | ||||
| (0.040 to 0.064%) | High | |||
| Positive | ||||
| (> 0.064%) | ||||
| Positive | 0 | 0 | 15 | 10 |
| Negative | 37 | 25 | 5 | 1 |
Table 1 Comparison to Evidentiary Breath Test (Alco-Sensor IV)
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Additionally, the BreathScan® Alcohol Detector was 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) with one exception. This exception was that 1 false positive reading out of 1200 readings of the .04 tester that did not contain alcohol.
5.8 Substantial Equivalence
| SIMILARITIES | ||
|---|---|---|
| Parameter | BreathScan® | CONNECTABLES® |
| Indications for Use | Detect the presence of alcohol in the human breath. | Detect the presence of alcohol in the human breath. |
| Target Populations | Over the Counter | Over the Counter |
| Calibration/Accuracy Checks | None required | None required |
| Anatomical Site | Mouth | Mouth |
| Test Sample | Human breath | Human breath |
Similarities and Differences Between BreathScan® and CONNECTABLES®
| DIFFERENCES | ||
|---|---|---|
| Parameter | BreathScan® | CONNECTABLES® |
| Result | Qualitative | Semi-Quantitative |
| Interpretation | Visual Color Change | Red, Yellow, and Green LEDs |
| Instrument system | None | Semiconductor-Oxide Sensor |
| Measurement Range | Separate devices are pre- | |
| calibrated to turn color at | ||
| different cut-offs: .02%,. | ||
| .04%, .05%, and .08% | Upper limit undefined – any | |
| concentration greater than | ||
| 0.04% will produce red light | ||
| Mouthpiece | None required | Replaceable |
| Blowing Time | 12 seconds | 3 seconds |
| Warm Up Time | None | 5-15 seconds |
| Size | 2 ¾ by 1/3 inches | 2.1 by 1.64 inches |
| Weight | 1.9067 grams | 42 grams |
| Power Requirement | None | 2-AAA alkaline batteries |
3
5.9 Conclusions
After analyzing bench test and user testing data, it is the conclusion of Akers Biosciences, Inc. that the BreathScan® Alcohol Detector 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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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 its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 28 2005
Ms. Barbara Bagby Director Regulatory Affairs Akers BioSciences, Inc. 201 Grove Road Thorofare, NJ 08086
Re: K060761
Trade/Device Name: BreathScan Alcohol Detectors (0.02, 0.04, 0.05 and 0.08% BAC) Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: March 17, 2006 Received: March 22, 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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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 G
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
6
Indications for Use
510(k) Number (if known): K060761
Device Name:
BreathScan® Alcohol Detector
Indications For Use:
The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs including 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Cffcl
Division Sign-Off
Unvision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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