(140 days)
Not Found
No
The description details a visually read, qualitative chemical test strip and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is an in vitro diagnostic test for detecting alcohol in human saliva, used for diagnosis rather than treatment or prevention of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use."
No
The device description clearly states it is a "test strip" and a "disposable test," indicating a physical, hardware-based device for in vitro diagnostic use.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of the Test: The device is a qualitative screening test that detects the presence of ethyl alcohol in human saliva. This is a test performed on a biological sample (saliva) outside of the body (in vitro) to aid in diagnosis (diagnosis of alcohol intoxication).
- Purpose: The results are used for the "diagnosis of alcohol intoxication." This directly aligns with the purpose of an IVD, which is to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
DIC
Device Description
ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The performance characteristics of Alco-Screen® 02 were determined by conducting precision and reproducibility studies, analytical specificity studies, stability studies, and field use studies with an evidentiary device. Results demonstrate that Alco-Screen® performs as intended and meets all established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.
0
K12/256
Traditional 510(k) Alco-Screen® 02
SEP 12 2012
Section 5: 510(k) Summary
Assigned 510(k) number:
Company:
Chematics Inc. PO Box 293 4519 Highway 13 South North Webster, IN USA 46555 Phone: 574-834-2406 Fax: 574-834-7427
Contact:
Carl Reynolds Phone: 513-265-6257 574-834-2406 Email: creynolds@chematics.com
Date Prepared: March 23, 2012
Alco-Screen® 02 Proprietary Name:
Classification Name:
Classification:
Predicate Devices:
Device Description:
Alcohol test system
21 CFR 862.3040, Class II, Product Code DIC
K894001 Orasure Technologies Inc, QED A150 Saliva Alcohol Test
ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
Intended Use:
The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
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Technological Comparison to Predicate Device:
Alco-Screen® 02 is similar to the predicate device. Both tests can be used to qualitatively measure alcohol in human saliva. Additionally, both employ enzymatic oxidation of alcohol and chromogenic reaction methodology to produce a visually interpreted color change. Performance test results confirm that design differences do not pose new issues of safety or effectiveness.
Performance Testing:
The performance characteristics of Alco-Screen® 02 were determined by conducting precision and reproducibility studies, analytical specificity studies, stability studies, and field use studies with an evidentiary device. Results demonstrate that Alco-Screen® performs as intended and meets all established specifications.
Conclusion:
Based upon the design, technology, performance, and intended use, Alco-Screen® 02 is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
10903 New Hampshire Avenue Silver Spring, MD 20993
Chematics, Inc. c/o Carl Reynolds Regulatory Affairs Specialist P.O Box 293 4519 Highway 13 South North Webster, IN 46555
SEP 12 2012
Re: K121256 Alco-Screen 02 Saliva Alcohol Test Trade/Device Name: Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol Test System Regulatory Class: Class II Product Code: DIC Dated: August 13, 2012 Received: August 16, 2012
Dear Mr. Reynolds:
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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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/ReportalProblem/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,
Countney 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
4
Indications for Use Form
510(k) Number (if known): K121256
Device Name: Alco-Screen® 02 Saliva Alcohol Test
Indications for Use: The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
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)
C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121278
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