(115 days)
Not Found
No
The device description and performance studies focus on a gas sensor and standard electrical/EMC testing, with no mention of AI/ML terms or data-driven training/testing.
No
The device measures alcohol in human breath for the diagnosis of alcohol intoxication, but it does not treat or prevent any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description explicitly states it is a "Breath-alcohol tester" operated by a "gas sensor of semi-conductors type," indicating it is a hardware device with a physical sensor.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained by this device are used in the "diagnosis of alcohol intoxication." This directly aligns with the definition of an IVD, which is a medical device used to examine 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.
While the device description focuses on the technology and operation, the crucial factor for determining if it's an IVD is its intended use in diagnosis using a human specimen.
N/A
Intended Use / Indications for Use
The Alco-Scan AL-5000 Breath Alcohol Tester is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes
DJZ
Device Description
AL-5000 is a Breath-alcohol tester designed to measure alcohol in the human breath. And AL-5000 is a D.O.T. approved device and a blow time of 3 seconds is required to capture an accurate deep lung sample. AL-5000 is operated by gas sensor of semi-conductors type for the detection of blood alcohol concentration ( BAC ) from human breath.
The sensor consists of mainly sensing layer and heating element which is formed by a n-type semiconductor powder and heater, respectively. In clean air, during the heater is powered, the oxygen molecules in the air traps the electron in the semiconducting material and then chemisorped on the surface of the powder particles. However, when it is exposed to organic vapor such as alcohol, the chemisoped oxygen ( O- or O2- ) is reacted with organic vapor and reduced.
By this reaction, the electrons trapped by oxygen is released and flow in the semiconductor. That is, when is exposed to organic vapor, the electrical conductivity increase ( the resistance decreases ).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Through a electrical safety, EMC and DOT tests, we, Sentech Korea Corp., came to the conclusion that AL-5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use. thus rendering it substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Kou1922
510(k) Summary
-
- Applicant's Name ; Sentech Korea Corp.
-
- Address ; #803, Ilsan Technotown, 1141-1 Bakseok-dong,
Ilsan-gu, Goyang-si,
Kyeonggi-do, 411-722 Korea
-
- Phone #. ; 82-31-909-8804
- : 82-31-909-8803 * Fax #.
- ; Mr. Soo Hyun, Kim / Managing Director * Contact
-
- Identification of the Device ; Proprietary-Trade Name : AL-5000 Breath Alcohol Tester Classification Name : Device, breath trapping, alcohol, DJZ Common/ Usual Name:Breath-alcohol test system
-
- Equivalence legally marketed devices : AL-5000 is functionally similar to the AlcoMate CA2000. KHN Solution LLC, K041334.
-
- Indications for Use ( intended use ) ; AL-5000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
-
- Description of the Device ;
AL-5000 is a Breath-alcohol tester designed to measure alcohol in the human breath. And AL-5000 is a D.O.T. approved device and a blow time of 3 seconds is required to capture an accurate deep lung sample. AL-5000 is operated by gas sensor of semi-conductors type for the detection of blood alcohol concentration ( BAC ) from human breath.
OCT 3 0 2006
1
The sensor consists of mainly sensing layer and heating element which is formed by a n-type semiconductor powder and heater, respectively. In clean air, during the heater is powered, the oxygen molecules in the air traps the electron in the semiconducting material and then chemisorped on the surface of the powder particles. However, when it is exposed to organic vapor such as alcohol, the chemisoped oxygen ( O- or O2- ) is reacted with organic vapor and reduced.
By this reaction, the electrons trapped by oxygen is released and flow in the semiconductor. That is, when is exposed to organic vapor, the electrical conductivity increase ( the resistance decreases ).
| Feature | AlcoMate CA2000 | AL-5000 |
|---|---|---|
| Indication of | ||
| use | The device is intended to measure | |
| alcohol in the human breath. | ||
| Measurements obtained by this | ||
| device are used in the diagnosis of | ||
| alcohol intoxication. | Same | |
| Mode | Breath Alcohol Concentration | Same |
| Practitioner use | Over the counter | Same |
| Display | 3 Digit LED | Same |
| Power source | 9 Volt Alkaline Battery or | |
| auto cigar lighter (optional) | 2AA size Battery | |
| Test automation | Single button operation | Same |
| Battery life | 300 tests | Over 200 tests |
| Measure range | 0.00-0.10% BAC | Same |
- Substantial Equivalence Chart ;
2
| Type of sensor | Semi-conductive Alcohol Sensor | Same |
|---|---|---|
| Anatomical site | Mouth | Same |
| Mouthpiece | Washable | Disposable |
| Warm up time | Below 20 seconds | Below 21 seconds |
| DOT approval | Yes | Yes |
| Construction | Plastic case with internal | |
| circuit board | Same | |
| Size | 120x60x25 mm | 116x59x27 mm |
| Weight | 200 grams | 105 grams |
6. Conclusion :
Through a electrical safety, EMC and DOT tests, we, Sentech Korea Corp., came to the conclusion that AL-5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use. thus rendering it substantial equivalence to the predicate device.
:
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 3 0 2006
Sentech Korea Corporation c/o Laura Danielson TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55412-1891
K061922 Trade/Device Name: AL-5000 Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: October 5, 2006 Received: October 12, 2006
Dear Ms. Danielson:
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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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 G. A.
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
5
Indications for Use
510(k) Number (if known): K061922
Device Name: AL - 5000
Indications For Use : The Alco-Scan AL-5000 Breath Alcohol Tester is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
V Over-The-Counter Use (21 CFR 801 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)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety