(331 days)
Not Found
No
The device description and performance studies indicate a visually read, semi-quantitative chemical test, with no mention of AI/ML or related concepts.
No.
The device is a semi-quantitative screening test used to estimate Blood Alcohol Concentration (BAC) for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use."
No
The device description clearly states it consists of physical test strips, which are hardware components, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Nature of the Test: The device tests a human biological sample (saliva) to estimate a physiological parameter (Blood Alcohol Concentration) for diagnostic purposes (diagnosis of alcohol use or intoxication). This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.
Product codes
DIC
Device Description
ALCO-SCREEN® is a visually read semi-quantitative test for the detection of alcohol in saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 5 different cut-off levels. 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
Not Found
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® 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)
K093879 Mission® Saliva Alcohol Test Strip by ACON Laboratories Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Traditional 510(k)
Alco-Screen®
MAR 2 2 2013
:
·
| Section 5: 510(k) Summary | |
|---|---|
| Assigned 510(k) number: | K121247 |
| 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 | |
| Email: creynolds@chematics.com | |
| Date Prepared: | March 20, 2012 |
| Proprietary Name: | Alco-Screen® |
| Classification Name: | Alcohol test system |
| Classification: | 21 CFR 862.3040, Class II, Product Code DIC |
| Predicate Devices: | K093879 Mission® Saliva Alcohol Test Strip by ACON |
| Laboratories Inc. | |
| Device Description: | ALCO-SCREEN® is a visually read semi-quantitative test |
| for the detection of alcohol in saliva. The test strip | |
| indicates the relative Blood Alcohol Concentration (BAC) | |
| at 5 different cut-off levels. 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: | ALCO-SCREEN® is a semi-quantitative screening test |
| used to estimate the Blood Alcohol Concentration (BAC) | |
| using human saliva. The test strip estimates BAC at the | |
| 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are | |
| used in the diagnosis of alcohol use or intoxication. For in | |
| vitro diagnostic use. |
.
:
:
:
:
1
Technological Comparison to Predicate Device:
Performance Testing:
Conclusion:
Alco-Screen® is similar to the predicate device. Both are OTC screening tests used to semi-quantitatively measure alcohol in human saliva. Additionally, both use chromogenic reaction methodology with alcohol oxidase as the enzyme, and are interpreted by visually comparing color change to a chart. Performance test results confirm that design differences do not pose new issues of safety or effectiveness.
The performance characteristics of Alco-Screen® 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.
Based upon the design, technology, performance, and intended use, Alco-Screen 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 stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 22, 2013
Chematics, Inc. c/o Carl Reynolds Regulatory Affairs Specialist P.O Box 293 4519 Highway 13 South North Webster, IN 46555
Re: K121247
Trade/Device Name: Alco-Screen Saliva Alcohol Test Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC Dated: February 28, 2013 Received: March 12, 2013
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Carl Reynolds
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol Benson - S for
Courtney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121247
Device Name: Alco-Screen® Saliva Alcohol Test
Indications for Use:
ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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 Diagnostics and Radiological Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121247