ALCO-SCREEN by CHEMATICS, INC. | FDA 510(k) Summary

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.

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.

AI/ML Overview

The Alco-Screen® is a visually read, semi-quantitative test for alcohol detection in saliva, estimating Blood Alcohol Concentration (BAC) at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format with corresponding reported performance values. Instead, it makes a general statement: "Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."

However, based on the Intended Use and the description of the device's function, we can infer the primary performance characteristic would be its ability to accurately estimate BAC at the specified cut-off levels. The "Performance Testing" section further categorizes the types of studies conducted.

Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy of BAC estimation at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels.	"performs as intended and meets all established specifications."
Precision and Reproducibility	Studies were conducted to determine these characteristics.
Analytical Specificity	Studies were conducted to confirm this characteristic.
Stability	Studies were conducted to confirm this characteristic.
Field Use Performance	Studies were conducted, demonstrating the device's performance with an evidentiary device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the performance studies.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "field use studies" suggests prospective data collection in a realistic setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. Given that the device is a visually interpreted chemical test, the "ground truth" would likely be established through comparison with a reference method (e.g., a laboratory-based evidentiary alcohol test).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and therefore, no effect size of human readers improving with AI vs. without AI assistance is available. This device is a visually interpreted chemical test, not an AI-assisted diagnostic tool for interpretation by multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This question is not applicable to the Alco-Screen®. The device is a visually interpreted chemical test; there is no AI algorithm to evaluate in a standalone manner. The "human-in-the-loop" is always required for visual interpretation against a color chart.

7. Type of Ground Truth Used

While not explicitly stated as "ground truth," the description of "field use studies with an evidentiary device" implies that the device's performance was compared against a reference standard, likely a more accurate and validated method for measuring BAC (e.g., a breathalyzer or blood alcohol test used for legal or medical evidence).

8. Sample Size for the Training Set

The document does not mention a training set sample size. As this is a chemical test interpreted visually against a fixed color chart, it does not involve machine learning or a "training set" in the traditional sense of AI/algorithm development.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this type of device. The performance is assessed against established chemical reaction principles and comparison to reference methods.

Summary

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Traditional 510(k)
Alco-Screen®

MAR 2 2 2013

Section 5: 510(k) Summary
Assigned 510(k) number:	K121247
Company:	Chematics Inc.PO Box 2934519 Highway 13 SouthNorth Webster, IN USA 46555Phone: 574-834-2406Fax: 574-834-7427
Contact:	Carl ReynoldsPhone: 513-265-6257Email: 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 ACONLaboratories Inc.
Device Description:	ALCO-SCREEN® is a visually read semi-quantitative testfor the detection of alcohol in saliva. The test stripindicates the relative Blood Alcohol Concentration (BAC)at 5 different cut-off levels. The device consists of a box of24 individually packaged single test strips each designedfor single use and to be disposable, and instruction for use.
Intended Use:	ALCO-SCREEN® is a semi-quantitative screening testused to estimate the Blood Alcohol Concentration (BAC)using human saliva. The test strip estimates BAC at the0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results areused in the diagnosis of alcohol use or intoxication. For invitro diagnostic use.

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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.

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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-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

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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

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Indications for Use

510(k) Number (if known): K121247

Device Name: Alco-Screen® Saliva Alcohol Test

Indications for 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

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.