(149 days)
Not Found
No
The device description details a sensor-based measurement system using an oxide semiconductor sensor and resistance measurement. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device measures alcohol in breath to diagnose or aid in the detection of alcohol intoxication, but it does not treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication" and "Measurements obtained by this device are use as an aid in the detection of alcohol intoxication." This indicates its role in determining a medical condition.
No
The device description clearly details hardware components, including an oxide semiconductor sensor, LEDs, and a timer, indicating it is a physical device, not software-only.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained are used "in the diagnosis of alcohol intoxication" and "as an aid in the detection of alcohol intoxication." This directly aligns with the definition of an IVD, which is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Specimen: The device measures alcohol in human breath, which is a specimen derived from the human body.
- Purpose: The purpose is to provide information related to a medical condition (alcohol intoxication).
While the device is intended for over-the-counter use and provides semi-quantitative results, its stated diagnostic purpose makes it fall under the category of an IVD.
N/A
Intended Use / Indications for Use
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC
§ 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
DEC 1 9 2008
EXHIBIT 2
510(k) Summary for K082086 The Ashley Collection Inc. dba PROTOCOL 600 West 57th St. 2nd Floor New York, NY 10019 Tel 212-247-7294 Fax 212-247-1489 Contact: Robert Goldy, CEO Date prepared: November 13, 2008
-
- Identification of the Device: Proprietary-Trade Name: Protocol Alcohol Breath Checker Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
-
- Equivalent legally marketed devices K052448, Connectables Pocket Breathalyzer
-
- Indications for Use (intended use): This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
-
- Description of the Device: Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC 0.08
Yellow: BAC 0.04 to 0.08
Green: BAC DON'T DRINK AND DRIVE!
the green light is lit.
Warnings | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Using Alcohol Tester | | | | Our testing has shown that this device functions accurately for at least 400 tests. Based on NIAAA studies, (www.alcoholism.about.com) this corresponds to approximately one year of device use for most drinkers. YOU SHOULD REPLACE YOUR DEVICE ONE YEAR AFTER FIRST USE. FAILURE TO DO SO MAY CAUSE YOUR READINGS TO BE INACCURATE. If you are a heavy drinker or a heavy smoker, we strongly recommend replacing the unit sooner. | |
| WAIT 15 to 20 minutes after drinking alcohol. Alcohol in your mouth could give you an abnormally high reading. | | | | The Alcohol Tester" does not guarantee 100% accuracy or the same results of the breathalyzers used by law enforcement officials. Test results are guides only and should not be relied upon. Results can be affected by environmental conditions, direct sunlight, excessive heat, submersion in liquids, improper usage, and elapsed time after drinking, amount of food consumption, medication and other drugs consumed. It is strongly advised that no motor vehicle or equipment be used after consuming any amount of alcohol, regardless of the results of the Alcohol Tester. The Alcohol Tester uses a colored LED indicator system (Green, Yellow, and Red) to deliver test results. Results should not be interpreted by individuals who are colorblind or visually impaired. | |
| Press and hold the POWER button until just the green LED is lit. When just the green LED is lit, the unit is ready for testing. Hold the power button continuously during and after the testing. | | | | Specifications | |
| Take a deep breath and exhale into the sensor at top of unit for 3 seconds slowly and consistently. The test results will occur immediately. Do NOT touch the top of the unit with your lips. | | | | Test Method: Product uses a semi-conductor gas sensor to detect alcohol on breath and converts it to a BAC level.
Preheat time: 5 to 15 seconds (unless the Alcohol Tester was just used) | |
| Observe which LEDs appear. See the chart below for the LED codes. | | | | Battery life: About 200 tests with two "AAA" alkaline batteries
Calibration: Breath alcohol simulator with 0.05 and 0.08 BAC solution, done in factory at time of manufacture
Device life: One year, approximately 400 tests.
Operating temperature: 10 to 40°C
Storage temperature: 0 to 50°C | |
| Replace unit after one year. See Warnings
Wait 15-20 seconds before running the test again | | | | Other Functions | |
| | | What the LEDs mean: | | Light Function | |
| RED
and
YELLOW | Image: Red and Yellow LED | BAC of
.08%
or
greater | LEGALLY
INTOXICATED. | Set the light switch to position to turn on the light. Do not use the light while using the alcohol tester. | |
| YELLOW | Image: Yellow LED | BAC of
.05%
to
.08% | CAUTION:
BORDERLINE
INTOXICATED. | Count-up timer | |
| GREEN | Image: Green LED | BAC of
less
than
.05% | LOW or
MODERATE LEVEL
BUT YOUR
DRIVING MIGHT
STILL BE
IMPAIRED | 1. Press the START/STOP button to start the count-up timer when the setting is 0:00
- Description of the Device: Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC 0.08
- Press the START/STOP button again to stop the count-up timer.
- To reset the count-up timer to 0:00, press the HR and MIN buttons at the same time. | |
| No
Lights | Image: No Lights | | Replace the batteries | Countdown timer | |
| "BAC" means "Blood Alcohol Concentration" | | | | 1. Press HR or MIN buttons to set the countdown HOUR or MINUTE. - Press the START/STOP button to start the countdown timer.
- Press the START/STOP button again to stop the countdown timer.
- A two second warning signal will be given at the last 10 and 5 minutes.
- The alarm of the countdown timer lasts 60 seconds.
Pressing the HR and MIN buttons at the same time can stop the alarm earlier. - To reset the countdown timer to 0:00 press the HR and MIN buttons at the same time. | |
| CAUTION: Your driving may be impaired at ANY level. This may be true even if only | | | | | |
র্ন ഗ്രാ This device is intended to measure alcohol in the
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| | RED
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MODERATE
BUT YOUR
DRIVING
STILL BE
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|--|----------------------|---------------------------------|--|--------------------------------------|------------------------------|--|-------|--------------------------------|-------------------------------------------------------------------|-----------------------|
| | | | | | | | | | | Replace the batteries |
| | | | | | | | | | | No |
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol to the right, resembling a person with outstretched arms. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Ashley Collection, Inc. Attn: Mr. Robert Goldy 600 West 57th St., 2nd Floor New York, NY 10019
DEC 1 9 2008
Re: K082086
Trade Name: Protocol Alcohol Breath Alcohol Tester Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: November 14, 2008 Reccived: November 17, 2008
Dear Mr. Goldy:
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).
4
Page 2 -
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K082086 510(k) Number:
Device Name: Alcohol Breath Tester
Indications for Use:
This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.
Prescription Use: (Part 21 CFR 801 Subpart D) and/or
Over-the-Counter Use (OTC):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)
A
Division Sign-Off Office of In Vitro Diagnostic Devices, Evaluation and Safety 510(k) No. K082086