(90 days)
Not Found
No
The description focuses on a semiconductor-based gas sensor and standard breath analysis, with no mention of AI or ML terms or concepts.
No
The device is used for diagnosis, specifically for measuring alcohol in breath to diagnose alcoholic intoxication, not for treatment or therapy.
Yes
The document states that "Measurements obtained by this device are used in the diagnosis of alcoholic intoxication."
No
The device description explicitly states it uses a semiconductor-based gas sensor to analyze breath samples, indicating it includes hardware components beyond just software.
Based on the provided information, the AL-6000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that measurements obtained by the device are used in the diagnosis of alcoholic intoxication. This is a key characteristic of an IVD device, 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.
- Diagnostic Purpose: The results are used to aid in the diagnosis of a medical condition (alcoholic intoxication).
While the device description focuses on the technology and how it works, the intended use clearly places it within the realm of IVD devices.
N/A
Intended Use / Indications for Use
The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The AL-6000 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 (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
The STK3100 semiconductor sensor consists primarily of a sensing layer and heating element, which is formed by an n-type semiconductor powder and heater, respectively. When the heater is powered in clean air, oxygen molecules in the air trap electrons in the semiconducting material after which they are chemically absorbed on the surface of the powder particles. However, when the STK3100 is exposed to ethanol vapor, the absorbed oxygen (O or Oz) reacts with the gas and is reduced. By this reaction, the electrons trapped by the oxygen are released and flow through the semiconductor, which means that resistance decreases and electrical conductivity increases.
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)
Benchmark and safety testing, EMC/DOT testing and risk analysis, as well as practical user testing, reveal that the AL-6000 performs within the same ranges of safety and effectiveness as those of the predicate device. The AL-6000 and predicate device describe the same indications for use and similarly well-proven methods of technical analysis (breath alcohol to BAC using semiconductor oxide sensors). Results show that the devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Range: 0.00% to 0.40%
Measurement Accuracy: +/-0.01 at 0.10% BAC
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
K060 343
510(k) Summary
| APPLICANT NAME: | Sentech Korea Corp. | |
|---|---|---|
| ADDRESS: | 803 Ilsan Techno Town | |
| 1141-1 Bakseok-Dong | ||
| Ilsan-gu, Goyang-Si | ||
| Kyeonggi-do, 411-722 | ||
| Republic of Korea | MAY 11 2005 | |
| PHONE: | 82-31-909-8804 | |
| FAX: | 82-31-909-8803 | |
| CONTACT: | Mr. Soo Hyun Kim, Managing Director | |
| DATE: | 11/18/2005 |
1. Identification of Device
Proprietary/Trade Name: AL-6000 Breath Alcohol Tester Classification Name: Device, Breath Trapping, Alcohol, DJZ Common Name: Breath Alcohol Test System
Equivalent Legally Marketed Device 2.
AlcoMate (Model CA2000) - KHN Solutions, LLC / K041334
3. Indications for Use (Intended Use)
The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
4. Device Description
The AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
The STK3100 semiconductor sensor consists primarily of a sensing layer and heating element, which is formed by an n-type semiconductor powder and heater, respectively. When the heater is powered in clean air,
1
oxygen molecules in the air trap electrons in the semiconducting material after which they are chemically absorbed on the surface of the powder particles. However, when the STK3100 is exposed to ethanol vapor, the absorbed oxygen (O or Oz) reacts with the gas and is reduced. By this reaction, the electrons trapped by the oxygen are released and flow through the semiconductor, which means that resistance decreases and electrical conductivity increases.
5. Substantial Equivalence Chart
| Device: AlcoMate CA2000 | Device: AL-6000 | |
|---|---|---|
| Indications for Use | Measures alcohol content in | |
| the human breath for | ||
| detection/diagnosis of | ||
| alcoholic intoxication | Measures alcohol content in | |
| the human breath for | ||
| detection/diagnosis of | ||
| alcoholic intoxication | ||
| Method | Breath alcohol concentration | |
| to BAC | Breath alcohol | |
| concentration to BAC | ||
| Measurement Range | 0.00% to 0.40% | 0.00% to 0.40% |
| Measurement Accuracy | +/-0.01 at 0.10% BAC | +/-0.01 at 0.10% BAC |
| Sensor Type | Semiconductor oxide sensor | Semiconductor oxide sensor |
| Power Source | 9V alkaline battery | Two 1.5V AA batteries |
| Testing Capacity | Approx. 300 (1 battery) | Approx. 300 (2 batteries) |
| Certification | DOT / NHTSA | DOT / NHTSA |
| Practitioner Use | Over-the-counter | Over-the-counter |
| Construction | Circuit board housed in | |
| plastic casing, replaceable | ||
| mouthpieces | Circuit board housed in | |
| plastic casing, replaceable | ||
| mouthpieces | ||
| Warmup Time | About 20 seconds | About 20 seconds |
| Display | 3-digit LED | 3-digit LED |
| Dimensions | 5" x 3¼" x 1" | 5½" x 3" x 2" |
| Weight | 171 g | 117 g |
6. Conclusion
Benchmark and safety testing, EMC/DOT testing and risk analysis, as well as practical user testing, reveal that the AL-6000 performs within the same ranges of safety and effectiveness as those of the predicate device. The AL-6000 and predicate device describe the same indications for use and similarly well-proven methods of technical analysis (breath alcohol to BAC using semiconductor oxide sensors). Results show that the devices are substantially equivalent.
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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 streams emanating from its wing. 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
Sentech Korea Corp. c/o Mr. Matthew H. Son President AK Solutions USA LLC 21 Grand Ave. Suite 103 Palisades Park, NJ 07650
MAY 11 2006
K060343 Re:
Trade/Device Name: AL-6000 Alcohol Breath Tester Regulation Number: 21 CFR§862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: February 10, 2006 Received: March 1, 2006
Dear Mr. Son:
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. Iisting 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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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060343
Device Name: AL-6000 Alcohol Breath Tester
Indications For Use:
. ..
The AL-6000 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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)
CAC.n
Division Sign-Off
Office of In Vitro Dingnostic Device Evaluation and Safety
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510(k) L(060343