(158 days)
Not Found
No
The device description details a chemical reaction and visual comparison for results, with no mention of computational analysis, algorithms, or learning processes.
No
The device is an in vitro diagnostic (IVD) test for measuring alcohol in human saliva, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and "Results are used for the diagnosis of alcohol intoxication."
No
The device is a physical test strip that utilizes chemical reactions to produce a visual result, which is then compared to a color chart. It does not involve any software component for its primary function.
Yes, 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 only." and "The test is intended for both prescription and over-the-counter in vitro diagnostic use."
- Purpose: The device is designed to measure alcohol in human saliva to indicate alcohol intoxication, which is a diagnostic purpose.
- Sample Type: It analyzes a biological sample (saliva) in vitro (outside the body).
- Diagnostic Information: The results provide information about the presence and relative concentration of alcohol, which is used for diagnosis (of alcohol intoxication).
N/A
Intended Use / Indications for Use
The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only.
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
DIC
Device Description
The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For in vitro diagnostic use only.
The assay is a disposable test for one-time use.
The strip is for over-the-counter use.
The test is intended for both prescription and over-the-counter in vitro diagnostic use.
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)
Clinical study results indicate that the intended users were able to obtain comparable testing data when using the Teco Saliva Alcohol Test and the legally marketable ACON Mission Saliva Alcohol test.
The performance characteristics of the Teco Saliva Alcohol Test were verified using method comparison, precision, linearity, shelf life, and stress studies. Testing results indicate that the Teco Saliva Alcohol Test compared with the ACON Mission Saliva Alcohol tests perform satisfactorily when used appropriately, as outlined in the package insert.
The clinical studies results demonstrate a substantial equivalency on performance between Teco Saliva Alcohol Test with predicate test, ACON Mission Alcohol Saliva test.
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
Image /page/0/Picture/32 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font, with the 'T' slightly larger than the 'C'. The hexagon is solid black, providing a strong contrast to the white letters.
005 - 510(k) Summary
- 4 2011
A. 510(k) Number:
- B. Purpose for Submission: New Device
- C. Analyte:
- Saliva Alcohol
- D. Type of Test:
Semi-quantitative, chromogenic assay; visually read color change
-
E. Applicant:
Teco Diagnostics -
F. Trade Name: Teco Saliva Alcohol Test
G. Regulatory Information:
-
- Regulation section:
21 CFR 862.3040, Alcohol Test System
- Regulation section:
-
- Classification: Class II
-
- Product code: DIC
-
- Panel:
Toxicology (91)
H. Intended Use:
2. Indication(s) for use:
- The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only.
-
- Special conditions for use statement(s): The assay is a disposable test for one-time use.
The strip is for over-the-counter use.
I. Device Description:
The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch.
J. Substantial Equivalence Information:
-
- Predicate device name(s):
Mission Saliva Alcohol Test; Acon Inc.
- Predicate device name(s):
1
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiag.com
005 - 510(k) Summary
-
- Predicate 510(k) number(s): K093879
-
- Comparison with predicate:
| Trade Name | Teco Saliva Alcohol Test | ACON Mission Test |
|---|---|---|
| Manufacturer | Teco Diagnostics | ACON Labs |
| 510(k) number | N/A | K093879 |
| Intended use/indications | ||
| for use | The Saliva Alcohol Test is a rapid | |
| screening test used for measuring | ||
| alcohol in human saliva. Results are | ||
| used in the diagnosis of alcohol | ||
| intoxication. | Same | |
| Methodology | Chromogenic | Same |
| Enzyme | Alcohol oxidase | Same |
| Sample Types | Saliva | Same |
| Measuring Units | Blood Alcohol Concentration | |
| (BAC%) | Same | |
| Measuring Range | Negative | |
| 0.02% | ||
| 0.04% | ||
| 0.08% | ||
| 0.30% | Same | |
| Result | Semi-quantitative | Same |
| Read Time Window | 2 minutes | 2 to 3 minutes |
| Pad Methodology | Coupled enzymatic reactions using | |
| alcohol oxidase on ethyl alcohol in the | ||
| presence of peroxidase and enzyme | ||
| substrate such as tetramethylbenzidine | ||
| (TMB). | Same |
K. Test Principle:
The Teco Saliva Alcohol Test is a plastic strip tipped with a reactive pad containing tetramethylbenzidine, alcohol oxidase, and peroxidase. The test is utilizes two coupled enzymatic reactions to create the visual changes in the presence of varying amounts of saliva alcohol. The first reaction consists of an oxidation reaction where the ethanol in the saliva is converted to aldehyde by the alcohol oxidase. The second reaction is the oxidation of TMB, the color indicator substrate, and is catalyzed by the enzyme peroxidase. The color change of the pad corresponds to the amount of present alcohol in the sample. The results are read by comparing the colored pad to the color chart found on the strip package
L. Clinical Performance Characteristics:
2
Image /page/2/Picture/1 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a bold, sans-serif font, with the "T" slightly smaller than the "C". The hexagon is solid black, providing a strong contrast to the white letters.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiag.com
005 - 510(k) Summary
Clinical study results indicate that the intended users were able to obtain comparable testing data when using the Teco Saliva Alcohol Test and the legally marketable ACON Mission Saliva Alcohol test.
M. Conclusion:
The performance characteristics of the Teco Saliva Alcohol Test were verified using method comparison, precision, linearity, shelf life, and stress studies. Testing results indicate that the Teco Saliva Alcohol Test compared with the ACON Mission Saliva Alcohol tests perform satisfactorily when used appropriately, as outlined in the package insert.
The clinical studies results demonstrate a substantial equivalency on performance between Teco Saliva Alcohol Test with predicate test, ACON Mission Alcohol Saliva test.
3
Image /page/3/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 a stylized symbol that resembles an eagle or bird-like figure with three parallel lines above it.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring. MD 20993
BET 04 2011-
Teco Diagnostics c/o Mr. James Li 1268 N. Lakeview Avenue Anaheim. CA 92807
રિદ: K111206
Trade Name: Teco Saliva Alcohol Test Regulation Number: 21 CFR 862,3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC Dated: August 12, 2011 Received: August 17, 2011
Dear Mr. Li:
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).
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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/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,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111206
Device Name: Teco Saliva Alcohol Test
Indications For Use:
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_K 111200
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