(115 days)
Not Found
No
The device description and performance studies indicate a chemical reaction-based detection method with visual interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is used for diagnosis of alcohol intoxication and does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description clearly outlines physical components such as a plastic tube, plugs, blow bag, tube label, glass vial, and reaction crystals, indicating it is a hardware-based device with a chemical reaction mechanism, not software-only.
Based on the provided information, the Breath Alcohol Detector is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained by this device are used in the diagnosis of alcohol intoxication. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device works by analyzing exhaled breath, which is a specimen derived from the human body. The chemical reaction with the crystals to detect alcohol in the breath is a characteristic of an in vitro test.
- Clinical Tests: The clinical studies compare the device's performance to an evidentiary breath test, further supporting its use in a diagnostic context.
While the device is used over-the-counter and provides semi-quantitative results, its stated purpose of aiding in the diagnosis of alcohol intoxication firmly places it within the scope of an IVD.
N/A
Intended Use / Indications for Use
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes
DJZ
Device Description
The Breath Alcohol Detector is a visual semi-quantitative test for the detection of alcohol in the exhaled breath. The Breath Alcohol Detector consists of a plastic tube, two plastic plugs, a blow bag (optional), a tube label and a glass vial encased with reaction crystals. The crystals employ a solid-phase chemistry system based on chemically chromogenic reaction. Alcohol, if present in the exhaled breath, reacts with the chemically coated crystals and produces a color change. This color change is proportional to the concentration of alcohol in the breath, which is an approximation of relative Blood Alcohol Concentration (BAC). The Breath Alcohol Detector is available with or without blow bags in six cut-off levels: 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.
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)
Laboratory Testing: The performance characteristics of the Mission® Breath Alcohol Detector were evaluated by the following studies: precision, analytical specificity-blank reading, analytical specificity-cigarette smoke, analytical specificity-volatile substances, temperature flexibility, vibration effect, lighting effect and device comparison study.
Clinical Tests Performed: Clinical studies were conducted with laypersons and trained laboratory technicians using the Mission Breath Alcohol Detector. The study data were presented evaluating the accuracy of the Mission® Breath Alcohol Detector compared to an evidentiary breath test, Alco-Sensor IV, manufactured by Intoximeters Inc. which is a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007), per the ACON Clinical Study Protocol for the Breath Alcohol Detector. Study results indicate that nonprofessional, inexperienced laypersons were able to obtain comparable readings when using the Mission® Breath Alcohol Detector as compared to the results obtained by the trained technicians. In addition, the participating laypersons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use and the overall performance of the Mission® Breath Alcohol Detector.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
K093143, ACON Reply, Dated 11-Dec-09 Attachment F, 510(k) Summary for Breath Alcohol Detector
5. 510(k) SUMMARY
JAN 2 8 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The Assigned 510(k) number is _ K 09 31 4 3
Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121
Tel.: 858-875-8019 Fax: 858-875-8099
Date Prepared: October 2009
Contact Person:
Richard Lenart Regulatory Affairs Manager
Proprietary Name of the Device:
Mission® Breath Alcohol Detector
Common Name:
Breath-alcohol test system
Regulation Section and Classification:
Class I, Breath-alcohol test system 21 CFR § 862.3050
F-1 of F-4
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Product Code:
DJZ Devices, Breath trapping, alcohol
Medical Specialty:
Toxicology
Predicate Device:
BreathScan Alcohol Detector Akers Biosciences Inc., Thorofare, New Jersey, USA 08086. 510(k) Number: K060761
Description:
The Breath Alcohol Detector is a visual semi-quantitative test for the detection of alcohol in the exhaled breath. The Breath Alcohol Detector consists of a plastic tube, two plastic plugs, a blow bag (optional), a tube label and a glass vial encased with reaction crystals. The crystals employ a solid-phase chemistry system based on chemically chromogenic reaction. Alcohol, if present in the exhaled breath, reacts with the chemically coated crystals and produces a color change. This color change is proportional to the concentration of alcohol in the breath, which is an approximation of relative Blood Alcohol Concentration (BAC). The Breath Alcohol Detector is available with or without blow bags in six cut-off levels: 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.
Intended Use:
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels.
2
K093143, ACON Reply, Dated 11-Dec-09 Attachment F, 510(k) Summary for Breath Alcohol Detector
.
Technological Characteristics:
| Feature | Specifications |
|---|---|
| Methodology | Chromogenic reaction |
| Specimen | Exhaled breath |
| Measurement Range | 0.02%, 0.04%, 0.05%, 0.06, 0.08% and 0.10% |
| Measuring Units | BAC % |
| Reading Time | 2 minutes |
| Reading Stability | 5 minutes |
| Storage Temperature | 2-30°C (36-86°F) |
| Shelf Life | 3 years |
| Dimensions | 0.94 x 8.0 cm (0.37 x 3.15 inches) |
| Weight | 2.0 g (0.07 oz) |
.
Comparison to Predicate Devices:
The Mission® Breath Alcohol Detector is substantially equivalent to the Akers Biosciences BreathScan Alcohol Detector.
| Feature | Mission® Breath Alcohol
Detector | Akers Bioscience
BreathScan Alcohol
Detector |
|-------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Detect presence of alcohol in
exhaled breath | Same |
| Target Population | Over the counter | Same |
| Calibration | None required | Same |
| Methodology | Chromogenic reaction | Same |
| Anatomical Site | Mouth | Same |
| Test Sample | Exhaled breath | Same |
| Result | Semi-quantitative | Same |
| Interpretation | Visual color change | Same |
| Measuring Units | BAC % | Same |
| Mouthpiece | None required | Same |
| Blowing Time | 12 seconds | Same |
| Dimensions | 0.94 x 8.0 cm (0.37 x 3.15
inches) | Same |
| Weight | 2.0 g (0.07 oz) | Same |
| Differences | | |
| Measurement Range | Separate devices available at
different cut-off levels:
0.02%, 0.04%, 0.05%, 0.06%,
0.08% and 0.10% | Separate devices available at
different cut-off levels:
0.02%, 0.04%, 0.05%, and
0.08% |
| Blow Bag | May be used with or without
blow bag | None |
3
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Guidance documents included the "NHTSA/DOT Highway Safety Programs; Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids, (Federal Register/Vol.59, No.147, August 2, 1994/Notices/39382)," and NHTSA/DOT Highway Safety Programs; Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids, (Federal Register/Vol.73, No.62, March 3, 2008/Notices)"
Laboratory Testing:
The performance characteristics of the Mission® Breath Alcohol Detector were evaluated by the following studies: precision, analytical specificity-blank reading, analytical specificity-cigarette smoke, analytical specificity-volatile substances, temperature flexibility, vibration effect, lighting effect and device comparison study.
Discussion of Clinical Tests Performed:
Clinical studies were conducted with laypersons and trained laboratory technicians using the Mission Breath Alcohol Detector. The study data were presented evaluating the accuracy of the Mission® Breath Alcohol Detector compared to an evidentiary breath test, Alco-Sensor IV, manufactured by Intoximeters Inc. which is a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007), per the ACON Clinical Study Protocol for the Breath Alcohol Detector. Study results indicate that nonprofessional, inexperienced laypersons were able to obtain comparable readings when using the Mission® Breath Alcohol Detector as compared to the results obtained by the trained technicians. In addition, the participating laypersons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use and the overall performance of the Mission® Breath Alcohol Detector.
Conclusion:
The laboratory testing and clinical study results demonstrate that the Mission® Breath Alcohol Detector is safe, accurate and easy-to-use. It also demonstrates that the Mission® Breath Alcohol Detector is substantially equivalent to the Akers Biosciences BreathScan Alcohol Detector, currently sold on the U.S. market.
4
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 or bird symbol, with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Acon Laboratories, Inc. c/o Mr. Richard Lenart Regulatory Affairs Manager 10125 Mesa Rim Road San Diego, CA 92121
Re: K093143
Trade Name: Mission® Breath Alcohol Detector Regulation Number: 21 CFR §862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: December 11, 2009 Received: December 15, 2009
JAN 2 8 2010
Dear Mr Lenart:
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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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
6
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known): K o 9 3 l 4 3
Mission® Breath Alcohol Detector Device Name:
Indications for Use:
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicates relative Blood Alcoho! Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08% or 0.10% cut-off levels. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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