(263 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components. The device appears to be a standard breath alcohol tester with a simple sensor and display.
No.
The device is used for screening and diagnosis of alcoholic intoxication, which falls under diagnostic rather than therapeutic purposes. It does not actively 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 alcoholic intoxication."
No
The device description explicitly states it is a "self-contained unit with 3 digit LCD display, and power button" and is "powered by two AAA batteries," indicating it is a physical hardware device, not software only.
Based on the provided information, the PAD Breath Alcohol Tester is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that "Measurements obtained by this device are used in the diagnosis of alcoholic 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.
- Specimen: The device analyzes human breath, which is a specimen derived from the human body.
While the device is intended for Over-The-Counter use and doesn't involve complex imaging or AI, its core function of analyzing a human specimen (breath) to aid in diagnosis (alcoholic intoxication) firmly places it within the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
Product codes
DJZ
Device Description
The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration, high concentration, respectively. The unit is powered by two AAA batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human breath
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)
A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device. as well as perform comparably to an evidentiary type of breath alcohol tester.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The accuracy of this device has been established at a Blood Alcohol Concentrations of 0.008 and 0.032% BAC. Accuracy at a Blood Alcohol Concentration greater than 0.032% has not been established. Measurement Accuracy: +/-0.01 at 0.10%BAC
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.
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NOV 2 1 2011
510(K) Summary
1. Identification of the device Proprietary-Trade Name: PAD (Personal Alcohol Detector) Classification Name: DJZ, 21 CFR section 862.3050, Device, breath trapping, alcohol Common/Usual Name: Breath-alcohol test system
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- Equivalent legally marketed devices Model: AL2500 K Number: K053332
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- Indication for use (Intended use): The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
Intended use is the same as the predicate device
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- Description of the Device:
The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration , high concentration, respectively. The unit is powered by two AAA batteries.
- Description of the Device:
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- Safety and Effectiveness, comparison to predicate device
The results of bench and user testing indicate that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device. as well as perform comparably to an evidentiary type of breath alcohol tester.
- Safety and Effectiveness, comparison to predicate device
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- Substantial Equivalence Chart
| Item | Device | Predicate |
|---|---|---|
| Method | Breath alcohol concentration to BAC | Breath alcohol concentration to BAC |
| Measurement Accuracy | $\pm0.01$ at 0.10%BAC | $\pm0.01$ at 0.10%BAC |
| Sensor Type | Semiconductor oxide sensor | Semiconductor oxide sensor |
| Certification | Not currently, DOT approved | DOT/NHTSA |
Similarities
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| Warm-up time | About 20 seconds | About 20 seconds |
|---|---|---|
| Practitioner use | Over-The-Counter | Over-The-Counter |
| Construction | Circuit board housed in | |
| plastic casing | Circuit board housed in plastic | |
| casing | ||
| Construction | No mouthpiece | No mouthpiece |
| Display | 3-digit LCD | 3-digit LCD |
Differences
| Item | Device | Predicate |
|---|---|---|
| Power Source | 2(1.5V each) AAA alkaline | |
| batteries | 2(1.5V each) AA alkaline | |
| batteries | ||
| Testing Capacity | Approx. 800(on 2 batteries) | Approx. 200-300(on 2 batteries) |
| Measurement Range | 0.00% to 0.20% | 0.00% to 0.40% |
| Dimensions | 90x30x17mm | 5"×3¾"×1" |
| Weight | 45g | 171g |
7. Conclusion
After analyzing bench test, a risk analysis, EMC and user testing data, it is the conclusion of SEJU Engineering Col, Ltd. that the PAD is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The clinical trial performed 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 professional unit administered by a trained observer.
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Instructions for Use
Model: PAD
The PAD Breath Alcohol Test System is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. The accuracy of this device has been established at a Blood Alcohol Concentrations of 0.008 and 0.032% BAC. Accuracy at a Blood Alcohol Concentration greater than 0.032% has not been established.
The Personal Alcohol Detector PAD analyzes a breath sample to detect alcohol in the lungs. This reading is then converted to blood alcohol concentration (BAC). This device is designed for over-the-counter use. No mouthpiece is required.
Image /page/2/Figure/4 description: The image shows two views of a handheld device, possibly a meter or measuring tool. The front view features a display screen, with labels indicating "Power" and "Scale" near the bottom. The back view includes a CE marking, indicating compliance with European standards, and a set of horizontal lines at the top, possibly for ventilation or speaker output.
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2
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PART NAMES
Image /page/2/Picture/6 description: The image shows a digital display with the words "WAIT BLOW TEMP" at the top. The display reads "0.05" in large, bold digits. Below the digits are the symbols "%oo g/l mg/l %BAC".
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Inhaler
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Display window
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Power
-
Scale
-
Battery Compartment Cover
CAUTION
PAD is a screening device. Each individual's body responds differently to alcohol. Driving skills may be impaired at a level below the legal blood alcohol limit. Do not rely on results to determine level of intoxication or ability to safely operate a
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vehicle or machinery.
In addition, since this device visually shows the result on the Display Window, it is not appropriate for visually impaired people.
1. Operation
Make sure that you wait at least 25 minutes after drinking alcohol, smoking, or eating before testing. Please followed test procedure step 1~step3.
Power On/Off_and Self test function. Press Power button, and the device will start the self-test function to check
battery and sensor. During the self-test function, Display Window will show the count-down from '100' to '0' with "WAIT" message. The self-test function typically lasts about 20 seconds. If it is normal at self-test function. the procedure will go to step 2. In the case of abnormal condition, the messages "L-b"(Low Battery) or "S-E"(Sensor damaged) will be display on the Display Window with a beep sound. And then, the device will turn off automatically.
Breath Sample
It is important that to blow properly to inhaler to test blood alcoho! concentration (BAC).
a. When you push power button, Display Window show number that how many you tested and then display "Wait" and countdown "100" to "0".
b. When "0" and "BLOW" appear on the Display Window with a beep sound, blow your deep breath constantly into inhaler for 3-4 seconds.
c. After you finished blow breath, the unit will beep again when display blood alcohol concentration.(BAC)
d. If you don't blow within 20 seconds, the unit will turn off automatically with a beep sound.
Display
After the breath sample analyzed, the test result appears as percent measure of
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| Image: Graphic | blood alcohol concentration (BAC) from 0.00% to 0.20 % on the Display
Window. The BAC will be displayed for 20 seconds. And then, the device will
turn off automatically. |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note: | If you want to repeat test, start again from Step 1 to Step 3. |
2. Interpretation of the results
The generally accepted legal standard for alcohol intoxication in United States is 0.08 % BAC. However, your driving skills can be impaired even at a level of 0.03%BAC or lower. It is never safe to drink any amount of alcohol and drive. We recommend you "Don't drink and drive".
| Test results | Interpretation |
|---|---|
| Less than 0.03 %BAC | Driving skills may be impaired even at low levels. |
| 0.03 to 0.04 %BAC | Driving skills may be impaired at this level. |
| 0.05 %BAC or Over | Driving skills are always impaired at this level. |
• The result is displayed on the LCD screen by the increments of 0.01%BAC totally in 21 stages from 0.00%BAC to 0.20 %BAC. If alcohol concentration is above 0.20 %BAC, the message "HI" (high) will display.
3. Display window Messages
| Display | Meaning | What do I have to do? |
|---|---|---|
| L-b | ||
| (Low Battery) | Battery was discharged. | Replace with a new battery. |
| S-E | ||
| (Sensor Error) | There is a problem with | |
| the sensor. | ||
| The test environment is not | ||
| good. | Contact Customer Service. | |
| Test in a clean environment. |
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| t-F
(Test Fall) | Blowing strength or time is
not enough. | Blow more strongly for 3~4
seconds. |
|----------------------------|---------------------------------------------|-----------------------------------------------------------|
| L-t
(Low Temperature) | Test temperature is under
10°C (50°F) | Test at 10°C (50°F) ~ 40°C
(104°F) |
| n-C
(Need Calibration) | Test number is over 200
times. | Need Calibration at factory.
Contact Customer Service. |
| HI
(High Concentration) | Alcohol concentration is
above 0.20%BAC. | Take sufficient rest. |
4. Change Scale
Each countries use different scale. Please change scale when you go abroad.
Please follow the procedure for Change Scale.
| Step 1 | Please follow the test procedure step1, step 2.and step 3. When device display
the test result, please push the Scale button. The scale % BAC will be change
to %, g/l, and mg/l by push the Scale button. |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Step 2 | After select the Scale, please wait the device is turn off. From next time,
device will show the scale what you choose. |
5. Warnings.
a. Do NOT drop. This may damage the device, causing it not to work.
b. Do NOT tamper with the device. It may cause malfunction.
c. Please WAIT to test at least 25 minutes after drinking alcohol, smoking or eating. Otherwise, the remaining alcohol and smell in the mouth may lead to inaccuracy
d. Do not blow smoke, saliva, or other contaminants into inhaler, as the sensor may be damaged.
e. Do not use it as a means to drink and drive.
f. Do NOT keep the device in a dusty place. Dust accumulation on the PAD may cause
6
problems
g. Do NOT use or keep the device in a place where there are heavy moisture or traces of solvents such as Acetone. This may lead to malfunction.
h. Keep out of extreme temperature and out of reach of children.
i YOU SHOULD HAVE YOUR PAD CALIBRATED EVERY 6 MONTHS OR AFTER 200 TESTS. FAILURE TO DO SO MAY CAUSE YOUR READINGS TO BE INACCURATE. To obtain accuracy, the PAD requires recalibration every six months or after two hundred tests which comes first.
| Sensor Type | Semiconductor Gas Sensor |
|---|---|
| Operating Range | 0.00 %BAC to 0.20 %BAC |
| Warm-up Time | Less than 1 minute |
| Power Source | 2 AAA Alkaline batteries (included) |
| Test Capacity | More than 150 measurements |
| Operating Temperature | Operating 10°C (50°F) to 40°C (104°F) |
| Display | 3 digit LCD |
| Materials | ABS(body), PC(display part) |
| Dimensions | 90 X 30 X 17 mm |
| Weight | 45 g (including batteries) |
7. Specification
8. Warranty
We warrant the product to be free from defects in workmanship or material for 12 months normal service from the date of purchase. Our duty under this warranty is limited to replacing, adjusting, or repairing the device if returned along with proof of purchase. This warranty is void if device has been tampered with or damaged by the user. Recalibration is a predict maintenance procedure required of any and all breathalyzers in order to maintain accuracy, and such, is not a warranty service.
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9. Recalibration and Customer Service.
For recalibration or technical support, please contact us.
JC Global Inc. 23 Pepperidge Road Paramus, NJ.07652 Toll Free : 888-401-5917 Contact Richard Lee. Fax : 201-701-0337 Email : Sales@sejumicron.com Web: http//www.safe-drive.com
- This Instruction for use has been revised on 15 of Aug, 2011.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with the head, body, and legs depicted in a flowing, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 2 1 2011
SEJU Engineering Co., Ltd. C/O Business Association Co., Ltd Certification Division C/O Eileen Yang D-524 Migun Techno World2 Yuseong-Gu, Daejeon Republic of Korea 305-500
Re: K110614 Trade Name: PAD (Personal Alcohol Detector) Regulation Number: 21 CFR §862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class 1, reserved Product Codes: DJZ Dated: November 1, 2011 Received: November 17, 2011
Dear Ms. Yang:
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); 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).
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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/Medical Devices/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.
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if(Known): K_ | | OG14
Device Name: __ PAD __________
Indications For Use:
The PAD Breath Alcohol Test System is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
AND/OR
× Over-The-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices(OIVD)
D'ivision of Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 11 0614
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