The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.

Device Description

The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva at 0.0%, 0.02%, 0.08%, and 0.30% Blood Alcohol Concentration (BAC). Results are used in the diagnosis of alcohol intoxication. The test is a firm plastic strip with a test pad attached at the tip. The test pad contains chemicals that are highly sensitive to alcohol in saliva reacts with the chemicals to produce a color change on the test pad. The color change depends on the amount of alcohol present. The results are read by comparing the color of the test pad with the color chart. The test gives relative Blood Alcohol Concentration (BAC) from 0.02% to 0.30%.

AI/ML Overview

The Mission Saliva Alcohol Test Strip is a screening test designed to semi-quantitatively measure alcohol in human saliva to assist in the diagnosis of alcohol intoxication.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with specific numerical targets. Instead, it discusses the device's characteristics and compares them to a predicate device. The performance of the Mission Saliva Alcohol Test Strip was evaluated through laboratory testing and clinical studies to demonstrate its safety, accuracy, ease-of-use, and substantial equivalence to the predicate device.

Table of Device Characteristics and Intended Measurement Range:

Feature	Specification / Performance
Methodology	Chromogenic reaction
Specimen	Saliva
Measurement Range	Negative, 0.02%, 0.04%, 0.08%, and 0.30% BAC
Measuring Units	BAC %
Reading Time	2 minutes
Reading Stability	3 minutes
Storage Temperature	2-27°C (36-80°F)
Shelf Life	12 months
Dimensions	0.5 x 8.0 cm (0.20 x 3.15 inches)
Weight	0.16 g (0.006 oz)
Accuracy (Clinical)	Comparable readings by laypersons and technicians
Ease of Use	Satisfied laypersons using Instructions for Use

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify the exact sample size for the clinical study. It only states that "Clinical studies were conducted with laypersons and trained laboratory technicians."
Data Provenance: Not explicitly stated, but clinical studies were performed in the context of a 510(k) submission to the FDA, implying studies conducted under regulatory guidelines, likely within the US given the submission to the FDA. The study data was compared to an evidentiary breath test, Alco-Sensor IV, a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007). The study was likely prospective as it involved evaluating the device's performance in real-time.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: The ground truth for comparison was established using an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device." This reference implies that the Alco-Sensor IV results were considered the "expert" or gold standard, likely operated by trained technicians as mentioned in the clinical study description.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense of multiple human experts reviewing results. The comparison was between the Mission Saliva Alcohol Test Strip (interpreted by laypersons and trained technicians) and the Alco-Sensor IV (operated by trained technicians).

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

An MRMC comparative effectiveness study was not explicitly described in the provided text. The clinical study aimed to demonstrate that "non-professional, inexperienced laypersons were able to obtain comparable readings when using the Mission Saliva Alcohol Test Strip as compared to the results obtained by the trained technicians." This suggests a comparison of user groups (laypersons vs. trained technicians) with the device, but not a study to evaluate human readers' improvement with AI assistance.

6. Standalone Performance Study

The clinical study described seems to primarily evaluate the standalone performance of the Mission Saliva Alcohol Test Strip. It compares the device's results (whether interpreted by laypersons or trained technicians) directly against an evidentiary breath test device. There is no mention of an "AI" component or human-in-the-loop performance in the context of AI.

7. Type of Ground Truth Used

The ground truth used was established by an objective reference device: an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device."

8. Sample Size for the Training Set

The document does not describe separate training and test sets in the typical machine learning context. The studies mentioned (laboratory testing and clinical studies) appear to be for performance evaluation rather than algorithm training. Therefore, the sample size for a "training set" is not applicable or not provided.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an algorithm, these details are not applicable. The context is a diagnostic device that operates based on a chemical reaction, not a machine learning algorithm requiring a training phase with labeled data.

Summary

{0}------------------------------------------------

Attachment 2, 510k Summary Re: K093879, Reply Dated July 29, 2010 Page 1 of 4

ട്. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

్

K093879 The Assigned 510(k) number is _

AUG - 6 2010

Submitter's Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel.: 858-875-8019 Fax: 858-875-8099

Date Prepared: December 2009

Contact Person:

Richard Lenart Regulatory Affairs Manager

Proprietary Name of the Device:

Mission® Saliva Alcohol Test Strip

Commón Name:

Alcohol test system

{1}------------------------------------------------

Attachment 2, 510k Summary Re: K093879, Reply Dated July 29, 2010 Page 2 of 4

Regulation Section and Classification:

21 CFR § 862.3040 Alcohol test system

Class II

Product Code: -

DIC Alcohol dehydrogenase, specific reagent

Medical Specialty:

Toxicology

Predicate Device:

QED A150 Saliva Alcohol Test Orasure Technologies Inc., Bethlehem, PA 18018 510(k) Number: K894001

Description:

Intended Use:

{2}------------------------------------------------

Feature	Specifications
Methodology	Chromogenic reaction
Specimen	Saliva
Measurement Range	Negative, 0.02%, 0.04%, 0.08% and 0.30%
Measuring Units	BAC %
Reading Time	2 minutes
Reading Stability	3 minutes
Storage Temperature	2-27°C (36-80°F)
Shelf Life	12 months
Dimensions	0.5 x 8.0 cm (0.20 x 3.15 inches)
Weight	0.16 g (0.006 oz)

Technological Characteristics:

Comparison to Predicate Devices:

The Mission Saliva Alcohol Test Strip is substantially equivalent to the Orasure Technologies Inc. QED A150 Saliva Alcohol Test.

Feature	Mission Saliva Alcohol TestStrip	Orasure TechnologiesQED A150 Saliva Alcohol Test
Similarities
Intended Use	Detect presence of alcohol insaliva	Detect presence of alcohol insaliva
Calibration	None required	Same
Anatomical Site	Mouth	Same
Test Sample	Saliva	Same
Reading Time	2 minutes	Same
Differences
Measurement Range	Negative, 0.02%, 0.04%, 0.08%and 0.30%	0.01% to 0.145%
Target Population	Over the counter	Professional
Enzyme Used	Alcohol oxidase	Alcohol dehydrogenase
Result	Semi-quantitative	Quantitative
Interpretation	Visual color change using colorchart	Visual color change usingthermometer-like scale
Measuring Units	BAC %	%BAC and mg/dL

{3}------------------------------------------------

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Guidance documents included the "NHTSA/DOT Highway Safety Programs; Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids, (Federal Register/Vol.59, No.147, August 2, 1994/Notices/39382)," for Lighting Effect Study and "NHTSA/DOT Highway Safety Programs; Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids, (Federal Register/Vol.73, No.62, March 3, 2008/Notices)" for the remaining performance studies.

Laboratory Testing:

The performance characteristics of the Mission Saliva Alcohol Test Strip were evaluated by the following studies: precision, analytical specificity-blank reading, cigarette smoke interference, analytical specificity-volatile substances, temperature flexibility, lighting effect, reading time flexibility, and specimen storage and stability.

Discussion of Clinical Tests Performed:

Clinical studies were conducted with laypersons and trained laboratory technicians using the Mission Saliva Alcohol Test Strip. The study data were presented evaluating the accuracy of the Mission Saliva Alcohol Test Strip compared to an evidentiary breath test, Alco-Sensor IV, manufactured by Intoximeters Inc. which is a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007), per the ACON Clinical Study Protocol. Study results indicate that non-professional, inexperienced laypersons were able to obtain comparable readings when using the Mission Saliva Alcohol Test Strip as compared to the results obtained by the trained technicians. In addition, the participating laypersons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use and the overall performance of the Mission Saliva Alcohol Test Strip.

Conclusion:

The laboratory testing and clinical study results demonstrate that the Mission Saliva Alcohol Test Strip is safe, accurate and easy-to-use. It also demonstrates that the Mission Saliva Alcohol Test Strip is substantially equivalent to the Orasure Technologies QED A150 Saliva Alcohol Test, currently sold on the U.S. market.

{4}------------------------------------------------

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Acon Laboratories, Inc. c/o Mr. Richard Lenart 10125 Mesa Rim Rd. San Diego, CA 92121 (18

6 20190 ATEC

Re: K093879

Trade name: Mission Saliva Alcohol Test Strip Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol Test System Regulatory Class: Class II Product Code: DIC Dated: June 30, 2010 Received: July 01, 2010

Dear Mr. Lenart:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{5}------------------------------------------------

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/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K093877

Attachment 1, Indications for Use for Saliva Alcohol Test Re: K093879. Reply Dated August 4, 2010 Page 1 of 1

510(k) Number (if known): K093879

AUG - 6 2010

Mission® Saliva Alcohol Test Strip Device Name:

Indications for Use:

The Mission Saliva Alcohol Test Strip is a screening test used to semiquantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.

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 Diagnostic Devices (OIVD)

Chris S

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

510(k) K093879

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.