ALCO-SCREEN 02 by CHEMATICS, INC.

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Alco-Screen® 02 device's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format with specific metrics. However, it does indicate the device's intended performance.

Acceptance Criteria	Reported Device Performance
Detection of ethyl alcohol in human saliva	Qualitatively detects ethyl alcohol in human saliva
Detects relative Blood Alcohol Concentrations (BAC) ≥ 0.02%	Detects relative BAC ≥ 0.02%
Performs as intended	"Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."
Substantially equivalent to predicate device (Orasure Technologies Inc, QED A150 Saliva Alcohol Test)	"Alco-Screen® 02 is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act."

Study Details

Based on the provided information, the description of the studies is quite limited.

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "field use studies with an evidentiary device" but does not provide details on sample size, country of origin, or whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The device is a visually read qualitative test, not an AI-assisted diagnostic. There is no mention of human readers' performance improvement with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone test strip for visual interpretation. There is no algorithm involved in its direct interpretation; a human visually reads the color change.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated how the "true" BAC levels were determined for the performance tests. Given the nature of a BAC test, it's highly probable that a referencemethod (e.g., blood alcohol analysis or a calibrated breathalyzer) would be used as the ground truth.
The sample size for the training set: Not applicable. This device is a chemical test strip, not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary of "Performance Testing" Section:

The document states:

"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."

This paragraph briefly outlines the types of studies conducted but provides no quantitative results, sample sizes, methodology details, or specifics about the "evidentiary device" used in field studies. The "established specifications" are not detailed in the provided text.

Summary

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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

Intended 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.

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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 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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Page 2

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

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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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121278

Page 1 of 1

Regulation Number and Section

§ 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.