(222 days)
No
The description details a semiconductor sensor and an 8-bit microprocessor for control and measurement, but there is no mention of AI or ML algorithms being used for data processing or interpretation.
No.
The device is used for detection of alcohol intoxication, which is an informational purpose, not directly for treating, diagnosing, curing, or mitigating a disease or condition.
Yes
The device is intended to measure alcohol in human breath and detect alcohol intoxication, which are diagnostic purposes.
No
The device description explicitly details hardware components such as a semiconductor sensor, an 8-bit microprocessor, and an LCD display, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens in vitro (outside the body). This device analyzes breath, which is exhaled from the body, but the analysis is performed on the breath itself, not on a biological specimen like blood, urine, or tissue that has been removed from the body.
- The mechanism of action is a direct measurement of a substance in breath. The device uses a sensor to directly measure the concentration of alcohol in the breath sample. This is different from many IVDs which involve chemical reactions or other processes to detect or quantify analytes in a specimen.
- The intended use is for detecting alcohol intoxication through breath analysis. While the results relate to blood alcohol concentration, the measurement is taken from breath.
Therefore, while it's a diagnostic device in a general sense (it helps diagnose a condition - alcohol intoxication), it does not fit the definition of an In Vitro Diagnostic device as it does not analyze a biological specimen in vitro.
N/A
Intended Use / Indications for Use
Intended to measure alcohol in the human breath. Measurements obtained by this device are are used in the diagnosis of alcohol intoxication.
Product codes
DJZ
Device Description
The RMI® LCD Alcohol Tester is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1. The RMI® LCD Alcohol Tester is an alcohol screening device and uses a blowing time of 3 seconds to capture an accurate deep lung sample. The RMI® LCD Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The 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 employs a 3 digit LCD display which shows breath alcohol readings from 0.00 to 0.20 BAC (Breath Alcohol Concentration). Readings above 0.20 will display an LCD reading of "HI." The new device is a MODIFICATION of our old device, the Connectables® Alcohol Tester (K052448). We use the same sensor, but instead of three colored LEDs as indicators, the new device has a three digit LCD display of the measured BAC (breath alcohol concentration). Instead of analog comparators, we now employ an 8 bit microprocessor for control and measurement.
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
A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the 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 predicate unit administered by a trained observer.
Key Metrics
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.
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APR - 9 2007
510(k) Summary
RESOURCE MANAGEMENT INTERNATIONAL, LLC
2330 Ernie Krueger Circle Waukegan, IL 60087 Telephone: 847-244-4500 Fax: 847-244-4525 March 26, 2007 Contact: John Adams
1. Identification of the Device:
Proprietary-Trade Name: RMI® LCD Alcohol Tester Classification Name: Device, breath trapping, alcohol, FDA product code DJZ Common/Usual Name: Breath-alcohol test system
-
- Indications for Use (intended use) : Intended to measure alcohol in human breath. Measurements obtained by this device are used in the detection of alcohol intoxication.
-
- Description of the Device: The RMI® LCD Alcohol Tester is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1. The RMI® LCD Alcohol Tester is an alcohol screening device and uses a blowing time of 3 seconds to capture an accurate deep lung sample. The RMI® LCD Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The 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 employs a 3 digit LCD display which shows breath alcohol readings from 0.00 to 0.20 BAC (Breath Alcohol Concentration). Readings above 0.20 will display an LCD reading of "HI." The new device is a MODIFICATION of our old device, the Connectables® Alcohol Tester (K052448). We use the same sensor, but instead of three colored LEDs as indicators, the new device has a three digit LCD display of the measured BAC (breath alcohol concentration). Instead of analog comparators, we now employ an 8 bit microprocessor for control and measurement.
- Safety and Effectiveness, comparison to predicate device. The results of bench, and user న్ testing indicates 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.
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6. Substantial Equivalence Chart
| Feature | AlcoMate CA2000,
K041334 | Connectables® Alcohol
Tester K052448 | RMI LCD Alcohol
Tester |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| INDICATION For
USE | Intended to measure
alcohol in the human
breath. Measurements
obtained by this device
are used as an aid in
the detection of alcohol
intoxication. | SAME | SAME |
| MODE | Breath Alcohol
Concentration | SAME | SAME |
| PRACTITIONER
USE | Over the Counter | SAME | SAME |
| DISPLAY | 3 Digit LED | Red, Yellow, and Green
LEDs. Representing
ranges: BAC of greater
than .08% (red)
BAC of .04% to .08%
(yellow)
BAC of less than .04%
(green) | 3 Digit LCD, with blue
LED backlight |
| POWER SOURCE | 9 Volt Alkaline Battery | 2-AAA alkaline batteries | 2-AAA alkaline batteries |
| BATTERY LIFE | 100-300 tests | 400 Tests | 300 Tests |
| Measurement Range | 0.00-0.40% | Upper limit undefined -
any concentration greater
than 0.08% will produce a
red light. | 0.00-0.20%. Above 0.2%
unit indicates: HI |
| TYPE OF SENSOR | Semiconductor-Oxide
Sensor | SAME | SAME |
| ANATOMICAL SITE | Mouth | SAME | SAME |
| Mouthpiece | Replaceable | None required | None required |
| Warm Up Time | 15-60 Seconds | 5-15 seconds | 5-15 seconds |
| Blowing Time | 5 Seconds | 3 Seconds | 3 Seconds |
| Construction | Printed circuit board
inside plastic case. | SAME | SAME |
| SIZE | 5" x 2.55" | 1.64" x 2.1" | 3.5" x 1.25" |
| WEIGHT | 120 grams | 42 grams | 35 grams |
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, and user testing data, it is the conclusion of RESOURCE MANAGEMENT INTERNATIONAL, LLC that the RMI® LCD Alcohol Tester 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 predicate unit administered by a trained observer.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Resources Management International, LLC c/o Mr. Dan Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
APR - 9 2007
K062545 Re:
Trade/Device Name: RMI® LCD Alcohol Detector Regulation Number: 21 CFR 862.3050 Regulation Name: Alcohol test system. Regulatory Class: Class I, reserved Product Code: DJZ Dated: March 04, 2007 Received: March 07, 2007
Dear Mr. Kamm:
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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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.
Jean 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
4
Indications for Use
510(k) Number (If Known) K062545
Device Name: RMI® LCD Alcohol Detector
Indications for Use:
Intended to measure alcohol in the human breath. Measurements obtained by this device are 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)
William Kirk-Goff
L.vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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