(240 days)
Not Found
No
The device description relies on a chemical reaction and visual interpretation of a color change, with no mention of computational analysis, algorithms, or learning processes.
No
The devices are diagnostic tools intended for screening and detecting alcohol levels, not for treating conditions or diseases.
Yes
The device, "Alco-Breath Tube breath alcohol test," is described multiple times as an "in vitro diagnostic (IVD) device" for detecting alcohol in human breath, providing preliminary results and a semi-quantitative estimate of alcohol levels.
No
The device descriptions clearly indicate that both devices are physical, disposable devices that utilize a chemical reaction and color change on reagent-treated silica gel to detect alcohol. There is no mention of software being a component of either device.
Yes, based on the provided text, both the Alco-Breath Tube and the CheckPoint breath alcohol test are described as IVD (In Vitro Diagnostic) devices.
Here's why:
- Explicit Statement: The "Device Description" section for both devices explicitly states: "The [Device Name] is a disposable, one-time use in vitro diagnostic (IVD) device..."
- Nature of the Test: The devices test for alcohol in human breath, which is a bodily fluid. IVD devices are designed to examine specimens taken from the human body to provide information for diagnostic purposes. While these are screening tests and not for definitive diagnosis, they fit the general definition of an IVD.
- Intended Use: The intended use is for "screening in medical and therapeutic programs," which aligns with the application of IVD devices in healthcare settings.
Therefore, the text clearly identifies these devices as IVDs.
N/A
Intended Use / Indications for Use
Device Name: Alco-Breath Tube breath alcohol test
The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.
Device Name: CheckPoint breath alcohol test
The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results.
The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use.
The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results.
The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.
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
Not Found
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 conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. "Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids". (Federal Register: March 31, 2008. Vol 73, No.62, pgs. 16956 - 16960). This is the only national standard available for alcohol screening devices and is the same standard referenced in the 510(k) clearance for the predicate device. Usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert.
The performance characteristics of the Alco-Breath Tube and CheckPoint® Breath Alcohol Test were based on evaluations by the following analytical performance tests:
- Precision/ Reproducibility
- Traceability/ Stability/ Expected Values
- Detection Limit
- Analytical Specificity
- cigarette smoke
- temperature
- vibration
- Comparison Studies
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
Image /page/0/Picture/0 description: The image shows the word "ALCO" in bold, black letters. Above the word "ALCO" are several horizontal lines of varying lengths, creating a striped effect. A horizontal line underlines the word "ALCO", emphasizing the brand name. The overall design is simple and graphic, likely representing a logo or brand identifier.
510(k) SUMMARY
APR - 6 2011
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: | K102225 |
|---|---|
| -------------------------------- | --------- |
| Submitted By: | AlcoPro, Inc.
2547 Sutherland Avenue
Knoxville, TN 37939
USA
Telephone: 1-800 227-9890 |
|-----------------------------------|----------------------------------------------------------------------------------------------------|
| Company Contact: | Jack Singleton, President |
| Date Summary Prepared: | 7/26/2010 |
| Trade Name: | Alco-Breath Tube;
CheckPoint® Breath Alcohol Test |
| Common Name: | Devices, Breath trapping, alcohol |
| Regulation Number and Panel: | 862.3050 - Toxicology |
| Classification Product Code: | DJZ |
| Classification: | Class I |
| Substantially Equivalent Devices: | K060761 - BreathScan Alcohol Detector |
Device Description:
The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results.
The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use.
1
Image /page/1/Picture/0 description: The image shows the word "ALCO" in bold, black letters. To the right of the word, there are several horizontal lines that are also in black. The lines are stacked on top of each other and are of varying lengths. A horizontal line is present underneath the word "ALCO".
510(k) SUMMARY
The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results.
The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.
Intended Use/ Indications for Use:
Device Name: Alco-Breath Tube breath alcohol test
The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.
Device Name: CheckPoint breath alcohol test
The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.
Predicate Device:
The predicate device(s) for substantial equivalence in this submission are:
| Device Name | BreathScan Alcohol Detector |
|---|---|
| Company | Akers Biosciences, Inc. |
| 510(k) reference | K060761 |
Technology Comparison:
| Feature | Predicate Device:
BreathScan® Alcohol Detector
(K060761) | New Device:
Alco-Breath Tube | New Device:
CheckPoint® Breath
Alcohol Test |
|--------------|----------------------------------------------------------------|---------------------------------|---------------------------------------------------|
| Intended Use | Detect presence of alcohol in
exhaled breath | Same as predicate | Same as predicate |
2
Image /page/2/Picture/0 description: The image shows the logo for ALCO. The letters are in bold, sans-serif font. There are several horizontal lines to the right of the letters, which are stacked on top of each other.
| Feature | Predicate Device:
BreathScan® Alcohol Detector
(K060761) | New Device:
Alco-Breath Tube | New Device:
CheckPoint® Breath
Alcohol Test |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------|
| Target Population | Over the counter | Same as predicate | Same as predicate |
| Calibration/
Accuracy Checks | None required | Same as predicate | Same as predicate |
| Methodology | Chromogenic reaction | Same as predicate | Same as predicate |
| Anatomical Site | Mouth | Same as predicate | Same as predicate |
| Test Sample | Exhaled human breath | Same as predicate | Same as predicate |
| Blowing Time | 12 seconds | 1 minute | Same as predicate |
| Test Time | 2 minutes | Same as predicate | Same as predicate |
| Result | Qualitative | Same as predicate; also
provides semi-
quantitative results | Same as predicate |
| Interpretive Method | Visual Color Change | Same as predicate | Same as predicate |
| Measuring Units | BAC % | Same as predicate | Same as predicate |
| Measurement
Range | Separate devices available at
different cut-off levels: 0.02%,
0.04%, 0.05%, and 0.08% | Separate devices
available at different
cut-off levels: 0.04%
and 0.08% | Same as predicate |
| Mouthpiece | None Required | Same as predicate | Same as predicate |
| Collection Device | None Required | Balloon | Optional volumetric bag |
510(k) SUMMARY
Test Summary:
Performance data - Non-clinical/ Clinical
The conduct of performance evaluation studies is based on the most current National Highway Traffic Safety Administration (NHTSA)/ DOT guidance document. "Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids". (Federal Register: March 31, 2008. Vol 73, No.62, pgs. 16956 - 16960). This is the only national standard available for alcohol screening devices and is the same standard referenced in the 510(k) clearance for the predicate device. Usability tests were conducted to determine if consumers can correctly perform and interpret tests according to the package insert.
Performance Specifications -
The performance characteristics of the Alco-Breath Tube and CheckPoint® Breath Alcohol Test were based on evaluations by the following analytical performance tests:
- Precision/ Reproducibility 트
- l Traceability/ Stability/ Expected Values
- Detection Limit
- Analytical Specificity
- o cigarette smoke
- temperature o
- o vibration
- Comparison Studies
3
Image /page/3/Picture/0 description: The image shows the word "ALCO" in bold, black letters. The letters are slightly distorted, and there are several horizontal lines above the letters. The lines are also black and distorted, and they appear to be part of a logo or design.
510(k) SUMMARY
Conclusions:
The information in this 510(k) submission demonstrates that the Alco-Breath Tube and CheckPoint® Breath Alcohol Test is safe and effective for its intended use and is substantially equivalent to the predicate device.
4
Image /page/4/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 6 2011
Alcopro, Inc., c/o Seashore-Tetrachem Attn:Mr. Perry Rucker Consultant. Regulatory Affairs, & Compliance 1560 E. Edinger Avenue, Suite B Santa Ana. CA 92705
Re: K102225
Trade Name: Alco-Breath Tube, Checkpoint Breath Alcohol Test Regulation Number: 21 CFR §862.3050 Regulation Name: Breath Alcohol Test System. Regulatory Class: Class I, reserved Product Codes: DJZ Dated: February 10, 2011 Received: February 15, 2011
Dear Mr. Rucker:
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 Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney 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
510(k) Number (if known): 102225
Device Name: CheckPoint breath alcohol test
Indications for Use:
The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102225
Section 4, page Lof 2
i ﯩﻨﯩ
7
510(k) Number (if known): 102225
Device Name: Alco-Breath Tube breath alcohol test
Indications for Use:
The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC.
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 Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102221