(231 days)
Not Found
No
The device description and performance studies indicate a simple chemical reaction resulting in a color change, read by visual comparison to a chart. There is no mention of computational analysis, algorithms, or learning processes.
No
The device is a diagnostic test kit used to measure alcohol in saliva for the diagnosis of alcohol intoxication; it does not treat or prevent any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only."
No
The device description clearly states it is a "firm plastic strip with a test pad attached at the tip" containing chemicals that react to saliva. This describes a physical, hardware-based test strip, not a software-only device.
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 only."
- Purpose: The device is designed to measure alcohol in human saliva, which is a biological specimen.
- Diagnostic Use: The results are explicitly stated to be "used in the diagnosis of alcohol intoxication."
- Mechanism: The device uses a chemical reaction on a test pad to detect and semi-quantitatively measure alcohol in the saliva sample. This is a common characteristic of IVD tests.
The information provided strongly indicates that this device falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DIC
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%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the counter
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 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.
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.
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
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:
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%.
Intended Use:
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.
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 Test
Strip | Orasure Technologies
QED A150 Saliva Alcohol Test |
|-------------------|--------------------------------------------|------------------------------------------------------|
| Similarities | | |
| Intended Use | Detect presence of alcohol in
saliva | Detect presence of alcohol in
saliva |
| 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 color
chart | Visual color change using
thermometer-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,
AC
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
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