(172 days)
Not Found
No
The description details a sensor-based device with basic processing and display, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No
The device is intended to measure alcohol in human breath for the diagnosis of alcohol intoxication, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnostic of alcohol intoxication."
No
The device description clearly outlines hardware components such as a semiconductor-based gas sensor, LED displays, and mechanisms for breath sampling and money insertion. It is not solely software.
Based on the provided information, the IA ALIS device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure alcohol in human breath" and that "Measurements obtained by this device are used in the diagnostic of alcohol intoxication." This directly aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or other conditions. In this case, the specimen is breath, and the information is used for the diagnosis of alcohol intoxication.
- Specimen: The device analyzes a specimen taken from the human body (breath).
- Purpose: The purpose is to provide information for diagnosis (alcohol intoxication).
While the device is used over-the-counter and doesn't involve complex laboratory procedures, the core function of analyzing a human specimen to provide diagnostic information classifies it as an IVD.
N/A
Intended Use / Indications for Use
The IA ALIS is a device intended to measure alcohol in human breath. Results given by this device are used in the detection of alcohol intoxication.
Product codes
DJZ
Device Description
The IA ALIS is a self-contained device that uses a semiconductor-based gas . sensor and disposable straws for breath sampling and three 7-segment LED displays present the detected alcohol level. On the upper part of the screen there are fifteen lights for visual indication of . the level of alcohol detected. The LED screen displays the user's blood alcohol equivalent concentration in . two decimal places. On the bottom part of the screen there are four boxes for user instructions (step . 1, step 2, step 3 and Wait). The device starts working when money is inserted into the machine. After the . WAIT light goes on and the system performs a cleaning process, the BLOW light goes on and there is a beep when the device is ready to accept an air sample. As the user exhales with the straw into the hole, the device monitors the air . pressure and blowing time. If the flow of the breath sample is sufficient, the indicator BLOW light goes from flashing to solid and the WAIT light goes on. Thereafter the system processes the air sample and gives a numerical result.
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 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
The sponsor performed their own testing and collected performance data using the NHTSA requirements for precision and accuracy as a guide. These tests consist of 20 trials at a Blood Alcohol Concentration (BAC) of 0.008, 20 trials at a BAC of 0.032. Blood Alcohol Concentrations are simulated in breath by a Breath Alcohol Sample Simulator (BASS), "MARK IIA SIMULATOR", which provides an alcohol-in-air test sample with known alcohol level.
The NHTSA requirements for the Blank Reading: These tests consist of 20 trials under normal laboratory conditions at 0.00% BAC with non-alcoholic human breath for breath devices and non alcoholic bodily fluids.
The sponsor evaluated the possibility of cigarette smoke interference with the device. Five alcohol-free volunteers were asked to conduct five breath alcohol tests for each device cut-off concentration while smoking a cigarette. The testing was spread out to cover the duration of time it took to smoke a complete cigarette.
40 devices were tested at 40°C, 20 trials at a concentration of 0.008% BAC, and 20 trials at 0.032% BAC. We also performed 20 trials at 10℃ and 25℃.
The IA ALIS was placed on a vibration table for 5 minutes and twenty samples were performed using a Breath Alcohol Sample Simulator.
The sponsor performed a consumer study to determine if consumers could correctly use and interpret the device using only the supplied instructions on the front panel, and to compare the results to a device (AlcoMateCA2000). There were 65 paired comparisons, and the volunteers ranged in ages from 25 to 65 years (12 females and 53 males). Immediately afterward, the participants were your (12 other alcohol test using an AlcoMateCA2000 operated by a trained individual. The breath alcohol concentrations ranged from 0.00%BAC to 0.16%BAC (by the AlcoMateCA2000).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
- Precision/Reproducibility: The IA ALIS met all of the applicable NHTSA requirements for precision and accuracy. Summary results for 0.008% concentration showed 20 trials resulted in 0.00% BAC, and for 0.032% concentration, 20 trials resulted in 0.03% BAC.
- Blank Reading: Summary results for 0.00% concentration showed 20 trials resulted in 0.00% BAC.
- Linearity/assay reportable range: This device will report concentrations from 0.00% to 0.40% BAC. The device met all of the applicable NHTSA requirements for precision and accuracy up to a concentration of 0.03% BAC.
- Traceability, Stability, Expected values: The device is traceable to a commercially available certified alcohol reference solution at a concentration of 0.10% BAC. The acceptance criterion for accuracy is ±10% or ±0.01% BAC.
- Detection limit: The ALIS machine will report concentrations from 0.00% to 0.40% BAC.
- Analytical specificity (Cigarette Smoke): The IA ALIS Alcohol Tester produced no false positives results under smoking conditions.
- Temperature: Results from temperature testing showed successful performance across 10°C, 25°C, and 40°C for both 0.008% BAC and 0.032% BAC concentrations. For both concentrations, there were 20 successful trials out of 40 devices tested at each temperature.
- Vibration: Performance testing under vibration showed 20/20 successful trials for both 0.008% and 0.032% concentrations at 10-30 Hz and 30-60 Hz.
- Assay cut-off: For performance testing, a BAC Cut-off of 0.02% was used to distinguish positive from negative samples.
Comparison studies:
- Method of comparison with predicate device: A consumer study with 65 volunteers (12 females, 53 males) aged 25 to 65 compared the IA ALIS to the AlcoMateCA2000. Breath alcohol concentrations ranged from 0.00%BAC to 0.16%BAC. Linear regression analysis yielded a slope of 0.9976, a y-intercept of 0, and a correlation coefficient of 0.9892. Participants generally found the instructions easy to understand and the device easy to operate and interpret, with high agreement for all questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy acceptance criteria: ±10% or ±0.01% BAC
- Correlation Coefficient (R-squared): 0.9892 (from linear regression comparison study)
- Slope: 0.9976 (from linear regression comparison study)
- Y-intercept: 0 (from linear regression comparison study)
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
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEC 1 9 2008
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurement:
Breath alcohol
D. Type of Test:
Quantitative (semiconductor gas sensor)
E. Applicant:
4376081 Canada Inc, aka: IMPAIR AWARE
F. Proprietary and Established Names:
IA ALIS (Alcohol Level Indication system)
G. Regulatory Information:
-
- Regulation section: 21 CFR § 862.3050
-
- Classification: Class I, reserved
-
- Product code:
DJZ
-
- Panel:
Toxicology (91)
- Panel:
1
H. Intended Use:
-
- Intended use:
Refer to Indications for Use.
- Intended use:
-
- Indications for use:
The IA ALIS is a device intended to measure alcohol in human breath. Results given by this device are used in the detection of alcohol intoxication.
- Indications for use:
3. Special conditions for use statement:
Over the counter use
-
- Special instrument requirements:
Not applicable.
- Special instrument requirements:
I. Device Description:
- The IA ALIS is a self-contained device that uses a semiconductor-based gas . sensor and disposable straws for breath sampling and three 7-segment LED displays present the detected alcohol level.
- On the upper part of the screen there are fifteen lights for visual indication of . the level of alcohol detected.
- The LED screen displays the user's blood alcohol equivalent concentration in . two decimal places.
- On the bottom part of the screen there are four boxes for user instructions (step . 1, step 2, step 3 and Wait).
- The device starts working when money is inserted into the machine. After the . WAIT light goes on and the system performs a cleaning process, the BLOW light goes on and there is a beep when the device is ready to accept an air sample.
- As the user exhales with the straw into the hole, the device monitors the air . pressure and blowing time. If the flow of the breath sample is sufficient, the indicator BLOW light goes from flashing to solid and the WAIT light goes on.
- Thereafter the system processes the air sample and gives a numerical result. .
Use instructions:
The machine waits for a coin or bill to be inserted and then measures the amount of alcohol on BAC and displays the results. The operation has two stages:
Stage 1: Waiting for coin/bill
The "Step 1" light flashes while the device is waiting for a coin/bill to be inserted. During this stage, the control card is monitoring the sensor's temperature using an on/off control circuit. The temperature is controlled between 34C and 38C as required by the alcohol sensor manufacturer.
2
Stage 2: Monev Insertion
As soon as a coin/bill is detected, the following process begin:
- The control card generates a beep indicating that a valid input for the coin/bill has . been inserted.
- All LED's on the screen are turned off. .
- The air pump is turned on for 5 seconds for cleaning and decontaminating the . sensor and air conducts.
- The sensor heater is exposed to +5.5V. .
- The system waits for the user to blow air into the device. They should take a straw . to blow air into the machine. At the same time Step 3 light flashes (BLOW until WAIT light appears).
- After the sample has been collected the WAIT signal turns on. .
- The system analyzes the sample for about 5 seconds. .
- After the analysis is completed, the result is shown in the display; .
- Meanwhile, the machine starts a cleaning process in which the alcohol sensor is . decontaminated by increasing its voltage from 5V to 5.5V and the air pump is turned on for 20 seconds to clear the air conducts off any residues. If the result of the test was higher or equal to 0.12% BAC, the cleaning process is repeated twice. If the result was higher or equal to 0.20%, the cleaning process is repeated three times
- The control voltage returns to its nominal 5V value. .
Interpretation of results:
-
- If the sample is less than 0.02% BAC no alcohol detected
-
- If the sample is greater than 0.02%BAC alcohol detected
J. Substantial Equivalence Information:
-
- Predicate device name:
AlcoMateCA2000
- Predicate device name:
-
- Predicate 510(k) number:
K041334
- Predicate 510(k) number:
-
- Comparison with predicate:
Similarities | ||
---|---|---|
Item | Device | Predicate |
Indication for use | Intended to measure alcohol | |
in the human breath. | Intended to measure alcohol in the human | |
breath. Measurements obtained by this device | ||
are used as an aid in the detection of alcohol | ||
intoxication. | ||
Mode | Breath Alcohol Concentration | Breath Alcohol Concentration |
Practitioner use | Over the counter | Over the counter |
Type of sensor | Semi-conductor oxide | |
Sensor | Semi-conductor oxide Sensor | |
Display | 3 Digit LED | 3 Digit LED |
3
Measurement range | 0.00-0.40% | 0.00-0.40% |
---|---|---|
Anatomical site | Mouth | Mouth |
Differences | ||
Blow time | 8 Sec | 3.5 Sec |
Warm-up time | 60 Sec | 20 Sec |
Power source | Switching Adapter 12V, 2A | |
UL Listed | 9 Volt Alkaline Battery | |
Mouthpiece | Disposable Straw | Replaceable |
Battery life | N/A | 300 tests |
Construction | Printed circuit board inside a | |
metallic case | Printed circuit board inside plastic case | |
Weight | 17.6 Lb | 120 grams |
K. Standard/Guidance Document referenced (if applicable):
The sponsor states conformance to the following standards:
Department-of-Transportation-National-Highway-Traffic-Safety Administration 1. [Docket No. NHTSA-2006-24964] Highway Safety Programs; Model Specifications for Devices to Measure Breath Alcohol.
-
EN 61000-6-2:2001 (IEC 61000-6-2:1999, modified) Part 6-2: Generic Standards Immunity for industrial environments.
-
EN 61000-6-3:2001 (IEC 61000-6-3:1996, modified) Part 6-3: Generic standards: Emission standard for residential, commercial and light-industrial environments.
-
CISPR 16-2-3: 2003 Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-3: Methods c f measurement of disturbances and immunity - Radiated disturbance measurements.
-
EN 61000-3-2:2000 (IEC 61000-3-2: 2000 modified) Part 3-2: Limits for harmonic currents.
-
EN 61000-4-2:1995 +A1:1998 +A2:2001 (IEC 61000-4-2:1995 +A1:1998 +A2:2000) Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test.
7, EN 61000-4-11:1994 +A1:2001 (IEC 61000-4-11:1994 +A1:2000) Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity test
4
L. Test Principle:
The sensing material in the type of gas sensor we use in the Impair Aware ALIS is metal oxide SnO2.
Explanation of how it works:
When a metal oxide crystal SnO2 is heated at high temperature in air, oxygen is adsorbed on the crystal surface with a negative charge. Then donor electrons in the crystal surface are transferred to the adsorbed oxygen, resulting in leaving positive charges in a space charge layer. Thus, surface potential is formed to serve as a potential barrier against electron flow. Inside the sensor, electric current flows through the conjunction parts (grain boundary) of SnO2 micro crystals. At grain boundaries, adsorbed oxygen forms a potential barrier which prevents carriers from moving freely. The electrical resistance of the sensor is attributed to this potential barrier. In the presence of a deoxidizing gas, the surface density of the negatively charged oxygen decreases, so the barrier height in the grain boundary is reduced. The reduced barrier height decreases sensor resistance. The relationship between sensor resistance and the concentration of gas can be expressed by the following equation:
$$\mathsf{Rs} = \mathsf{A}[\mathsf{C}] \cdot \mathsf{a}$$
Where: Rs = electrical resistance of the sensor A = constant [C] = alcohol concentration a = slope of Rs curve
This resistance change can then be converted to a breath alcohol concentration which in turn is converted to a blood alcohol concentration.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility
This device was not tested by the National Highway Traffic Safety Administration (NHTSA). The sponsor performed their own testing and collected performance data using the NHTSA requirements for precision and accuracy as a guide. These tests consist of 20 trials at a Blood Alcohol Concentration (BAC) of 0.008, 20 trials at a BAC of 0.032. Blood Alcohol Concentrations are simulated in breath by a Breath Alcohol Sample Simulator (BASS), "MARK IIA SIMULATOR", which provides an alcohol-in-air test sample with known alcohol level. The IA ALIS met all of the applicable NHTSA requirements for precision and accuracy.
Summary results were as follows:
5
Concentration | 0.008% | 0.032% |
---|---|---|
0.00% BAC | 20 | 0 |
0.03% BAC | 0 | 20 |
b. Blank Reading
The NHTSA requirements for the Blank Reading: These tests consist of 20 trials under normal laboratory conditions at 0.00% BAC with non-alcoholic human breath for breath devices and non alcoholic bodily fluids.
Summary results were as follows:
Concentration | 0.00% |
---|---|
0.00% BAC | 20 |
-
c. Linearity/assay reportable range:
This device will report concentrations from 0.00% to 0.40% BAC However, the DOT Model Specifications require accuracy and precision testing up to a concentration of 0.03% BAC only; therefore, true linearity over the entire measuring range of the device was not evaluated. This device met all of the applicable NHTSA requirements for precision and accuracy as described above. -
d. Traceability, Stability, Expected values (controls, calibrators, or methods):
This device is traceable to a commercially available certified alcohol reference solution at a concentration of 0.10% BAC. This solution is used to calibrate the devices when manufactured.
The acceptance criterion for accuracy is ±10% or ±0.01% BAC
-
e. Detection limit:
The ALIS machine will report concentrations from 0.00% to 0.40% BAC. -
f. Analytical specificity: (Cigarette Smoke)
The sponsor evaluated the possibility of cigarette smoke interference with the device. Five alcohol-free volunteers were asked to conduct five breath alcohol tests for each device cut-off concentration while smoking a cigarette. The testing was spread out to cover the duration of time it took to smoke a complete cigarette. The IA ALIS Alcohol Tester produced no false positives results under these conditions. -
g. Temperature:
romportation
40 devices were tested at 40°C, 20 trials at a concentration of 0.008% BAC, and 20 trials at 0.032% BAC. We also performed 20 trials at 10℃ and 25℃. Summary results were as follows:
6
Concentration | 10°C | 25°C | 40°C |
---|---|---|---|
0.008% BAC | 20/40 | 20/40 | 20/40 |
0.032% BAC | 20/40 | 20/40 | 20/40 |
Note: The results are 20 trials / 40 devices
h. Vibration:
IA ALIS is a non-portable system, which is not subjected to any source of external or internal vibration. The system remains in a given site where users are moving towards it to take the test.
The IA ALIS was placed on a vibration table for 5 minutes and twenty samples were performed using a Breath Alcohol Sample Simulator. The results are presented in the table below:
Concentration | 10-30 Hz | 30-60 Hz |
---|---|---|
0.008 | 20/20 | 20/20 |
0.032 | 20/20 | 20/20 |
f. Assay cut-off:
For the purposes of performance testing, a BAC Cut-off of 0.02% was used to distinguish positive from negative samples.
All U.S. states have long-standing laws prohibiting driving while impaired by alcohol. In 49 states, it is also illegal to operate a motor vehicle with a blood alcohol concentration (BAC) above a specified limit. As of June 7, 2004 these states along with the District of Columbia and Puerto Rico, have adopted 0.08 % BAC as the legal level of intoxication.
The sponsor states that drivers may be impaired at a BAC of 0.02% or more and recommends they do not operate a motor vehicle at or above this concentration.
2. Comparison studies:
- a. Method of comparison with predicate device:
The sponsor performed a consumer study to determine if consumers could correctly use and interpret the device using only the supplied instructions on the front panel, and to compare the results to a device (AlcoMateCA2000). There were 65 paired comparisons, and the volunteers ranged in ages from 25 to 65
7
years (12 females and 53 males). Immediately afterward, the participants were your (12 other alcohol test using an AlcoMateCA2000 operated by a trained individual. The breath alcohol concentrations ranged from 0.00%BAC to 0.16%BAC (by the AlcoMateCA2000). Linear regression analysis of the data yielded a slope of 0.9976, a y-intercept of 0 and a correlation coefficient of 0.9892. After the study, participants were asked questions about ease of use and interpretation.
Image /page/7/Figure/1 description: The image shows a linear regression plot. The x and y axes are labeled '%BAC'. The plot shows a linear relationship between the two variables, with the data points labeled as 'AlcoMateCA2000'. The equation of the regression line is y = 0.9976x, and the R-squared value is 0.9892.
Age Range | Number | Male | Female |
---|---|---|---|
21-29 | 5 | 3 | 2 |
30-39 | 35 | 28 | 7 |
40-49 | 10 | 9 | 1 |
50-59 | 12 | 10 | 2 |
60-69 | 3 | 3 | 0 |
Total | 65 | 53 | 12 |
The results are presented below:
| Questions: | Strongly
disagree | Disagree | Neither
agree nor
disagree | Agree | Strongly
agree |
|-----------------------------------------------------------------------------|----------------------|----------|----------------------------------|-------|-------------------|
| The IA ALIS instructions are easy to
understand. | 0 | 0 | 0 | 10 | 55 |
| I understood how to use the IA ALIS
after reading the instruction manual | 0 | 0 | 0 | 3 | 62 |
| I was able to operate the IA ALIS
easily. | 0 | 0 | 0 | 5 | 60 |
8
| I was able to understand and interpret
the test results displayed by the IA
ALIS. | 0 | 0 | 0 | 6 | 59 |
---|---|---|---|---|---|
I am interested in using this device | 0 | 0 | 0 | 0 | 65 |
-
b. Matrix comparison:
Not applicable -
- Clinical studies:
- a. Clinical Sensitivity:
- Not applicable.
- b. Clinical specificity:
Not applicable.
-
c. Other clinical supportive data:
Not applicable -
- Clinical cut-off:
Not applicable.
- Clinical cut-off:
-
- Expected values/Reference range: Using these types of devices, alcohol is not detectable in the breath of persons who have not ingested alcohol.
-
- Software:
FDA has reviewed the applicant's Hazard Analysis and software development processes for this line of product types:
Yes X (see annex 7,8,9)
-
- Specimen Identification:
There is no mechanism to identify the specimen.
- Specimen Identification:
-
- Specimen Sampling and Handling:
The user provides a breath sample by exhaling into the device. The instrument checks for adequate breath flow and volume during sampling.
- Specimen Sampling and Handling:
-
- Calibration:
The device is calibrated at the factory before is sent. The sponsor recommends a recalibration interval of three months (typical) or 300 uses. Whichever comes first.
- Calibration:
9
The reasoning for the recalibration interval is because the bill capacity and the straw capacity are set at 300; for convenience we have set this value (300) as the estimated time frame to check on calibration. We consider that it's safer to set a calibration time so that our machines can always have excellent accuracy. See annexe 1 for more details.
10. Quality Control:
There are no external quality controls available for the consumer version of this device.
0. Proposed Labeling:
The labeling is sufficient and it satisfies the labeling requirements of 21 CFR 801.60, 21 CFR 801.61 and 21 CFR 801.62 for Over-the-Counter devices. (See annexe 6)
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision. (see annex 6)
10
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2008
Re:
c/o Federico Forcro 1100 Hammond Dr. Suite 410A-223 Atlanta, GA 30328
Canada, Inc.
K081855 Trade Name: Impair Aware Alcohol Level Indication System (IA ALIS) Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I (reserved) Product Codes: DJZ Dated: September 25, 2008 Received: September 30, 2008
Dear Mr. Forero:
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).
11
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
12
Indication for Use
510(k) Number (if known): K081855
Device Name: Impair Aware Alcohol Level Indication System (IA ALIS)
Indication For Use:
The IA ALIS device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnostic of alcohol intoxication.
Prescription Use (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) k08/855