(84 days)
Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
The AlcoMate is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoMate is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoMate contains a semiconductor oxide sensor designed to test for the presence of alcohol. The AlcoMate semiconductor contains a recently developed ceramic catalytic filter which greatly increases the sensors specificity to alcohol . The AlcoMate sensor uses oxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
Here's an analysis of the provided text regarding the AlcoMate CA2000 Digital Alcohol Detector's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (AlcoMate CA2000) |
|---|---|---|
| Indication of Use | Measurement of alcohol in human breath for diagnosis of alcohol intoxication. | SAME |
| Mode | Breath Alcohol Concentration | SAME |
| Practitioner Use | Over the Counter | SAME |
| Measurement Range | 0.00-0.40% | SAME |
| Accuracy | +/- 0.01% (at 0.10% BAC) | +/- 0.01% (at 0.10% BAC) |
| DOT Approval | (Alco-Sensor III) | YES |
Note: The document primarily shows the AlcoMate CA2000's performance as "SAME" as the predicate device, implying it meets the predicate's established performance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "bench, DOT, and user testing" and "bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data," but without specific numbers or details on the test subjects/data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given document. The summary focuses on comparing the new device to a predicate device and does not detail the process of establishing ground truth for any testing involving experts. It does mention "DOT testing," which implies adherence to specific standards that would involve calibrated equipment for ground truth, but not human experts in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given the nature of a breath alcohol test, adjudication methods involving multiple human readers are not typically applicable. The ground truth would likely be established through calibrated reference instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a standalone diagnostic tool, not an AI assistance tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire premise of a breathalyzer is its standalone capability to measure alcohol in the breath. The document states:
- "The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device."
- "After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Breathalyzer.net that the AlcoMate CA2000 is as safe and effective as the predicate device..."
These statements indicate that the device itself was tested for its accuracy and effectiveness.
7. The Type of Ground Truth Used
The ground truth for the AlcoMate CA2000's performance would have been established using calibrated reference standards and methods. The document mentions:
- "The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1"
- Its accuracy is stated as "±0.01 % at 0.10% BAC," implying comparison to a known, precise Blood Alcohol Concentration.
- "Calibration: BAC simulator" and "Calibration Interval: 1 year" further confirm the use of a calibrated simulator as the ground truth reference.
- "DOT Approval" generally requires adherence to specific protocols, which involve comparison to known alcohol concentrations in controlled environments.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This device is a sensor-based system that quantifies a physical property (alcohol concentration) based on established chemical principles and sensor response, rather than a machine learning or AI model that requires a distinct training set in the typical sense. Its "training" would be inherent in the sensor's design and calibration.
9. How the Ground Truth for the Training Set Was Established
Given that this is not an AI/ML device in the modern sense requiring a "training set," this question is not directly applicable. However, if we interpret "training" more broadly as the process of developing and manufacturing the sensor, the ground truth for establishing the sensor's accurate response to alcohol would be based on controlled environments with known concentrations of alcohol and calibrated reference instruments. The mention of "BAC simulator" for calibration points to this method.
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AUG 1 1 2004
EXHIBIT 2
| 510(k) Summary |
|---|
| Breathalyzer.net |
| A Division of KHN Solutions LLC |
| 1136 Montgomery Street |
| San Francisco, CA 94133 |
| Phone: 415-693-9756 |
| Toll-Free 1-877-334-6876 |
| Fax: 415 693-0215 |
| Email: info@breathalyzer.net |
May 14, 2004
Contact: Keith Nothacker, President
-
l . Identification of the Device:
Proprietary-Trade Name: AlcoMate CA2000 Digital Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system -
- Equivalent legally marketed devices This product is similar in function to the Preamendments device: . Alco-Sensor (Intoximeters, Inc. St. Louis, MO)
-
- Indications for Use (intended use) : The device is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
-
- Description of the Device: The AlcoMate is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoMate is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoMate contains a semiconductor oxide sensor designed to test for the presence of alcohol. The AlcoMate semiconductor contains a recently developed ceramic catalytic filter which greatly increases the sensors specificity to alcohol . The AlcoMate sensor uses oxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing
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a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, DOT, and user testing indicates that the new device is as safe and effective as the predicate device.
| Feature | Alco-Sensor (Pre-AmendmentsDevice) | AlcoMate CA2000 |
|---|---|---|
| INDICATION OF USE | The device is intended tomeasure alcohol in the humanbreath. Measurements obtainedby this device are used in thediagnosis of alcohol intoxication. | SAME |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| DISPLAY | 2 Digit LED | 3 Digit LED |
| POWER SOURCE | 9 Volt Alkaline Battery | SAME, or auto cigar lighter(Optional) |
| BATTERY LIFE | 300 Tests | SAME |
| Measurement Range | .00-.40% | SAME |
| Accuracy | +/-0.01% | SAME |
| TYPE OF SENSOR | Fuel cell sensor | Semiconductor-Oxide Sensor |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | SAME |
| Warm Up Time | None | 20 Seconds |
| DOT Approval | (Alco-Sensor III) | YES |
| Construction | Plastic case with internal circuitboard | SAME |
| SIZE | 5" x 3 ½" | 5" x 3 ¼" |
| WEIGHT | 171 grams. | 200 grams |
Substantial Equivalence Chart 6.
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, EMC, DOT testing and user testing data, it is the conclusion of Breathalyzer.net that the AlcoMate CA2000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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gital Alcohol Detector
AlcoMate Model CA 2000
The CA2000 is intended to measure alcohol in himan breath. Readings obtained by this device are used in the diagnois of I he CA2000 is meetired to measure in name over read. Academics of other Concentration of 0.008 and 0.032. Accuracy at a Blood Alcohol Concentration greater than 0.032 has not been evaluated.
Part names
Image /page/2/Figure/5 description: This image shows a diagram of a breathalyzer and instructions for its preparation. The diagram labels parts such as the "breath pipe", "display window" which reads "0.05", "ready lamp", and "battery low lamp". The instructions indicate that a 9 Volt Battery should be installed.
- The tester comes with one plastic mouthpiece already over the breath pipe. You may wish to replace the mouthpiece for 2. use by another person for sanitary reasons. To change mouthpieces, align the slot in the mouthpiece with the slot on the breath pipe.
Operation: Read these instructions before consuming alcohol.
- WAIT! 20 minutes after drinking alcohol before taking a reading. If you don't wait, the reading will measure alcohol in the mouth, which does not accurately show your blood alcohol level.
-
- Press the ON/OFF Power switch. WAIT! The detector will start to countdown from 200 to 000 on the display window. This warm up process prepares the sensor and circuit for testing. When you hear a BEEP and the green READY light comes on, go to step 2.
-
- Take a deep breath, then blow steadily and continuously (at least 5 seconds) into the pipe until you hear another BEEP. Your lips should be sealed around the mouthpiece while blowing. Be careful not to cover the Breath out opening on the unit. (If you don't blow within 30 seconds, the unit automatically displays "OFF" and will turn off.) After the red and green display lights blink for 4 seconds, the test result will be displayed for 15 seconds. This is your Blood Alcohol Concentration, or BAC. Finally, the unit shows "OFF" for turn-off, along the BEEP sound. Press the ON/Off power switch to turn unit off.
| Below 0.01% | 0.01 to 0.04% | 0.05% or Over | 0.40% or Over |
|---|---|---|---|
| If you drank very littlealcohol, your actualconcentration may be below0.01 %, and the reading maynot be activated. However,the display shows 0.00%and you're in the safe range. | The reading will bedisplayed. | The Red WARN LEDwill flash along with a"BEEP" sound. Yourability to drive may beimpaired. Don't drinkand drive! | Display will read "Hot"and the Red WARN LEDwill flash along with"BEEP" sound. |
If your blood alcohol concentration is:
For subsequent testing, repeat steps 1-2. Space tests at least 2 minutes apart.
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Understanding the Results
For many years, the legal standard for drunkenness across the United States was 0.10, but many states have now adopted the 0.08 standard. The federal government has pushed states to lower the legal limit. The now adopted the 7.00 standan says that a person can become impaired when the blood alcohol level hits 0.05. You should never drive an automobile when you are impaired by alcohol, drugs, or lack of proper rest.
Precautions
-
- You should wait 20 minutes after eating or drinking before testing. Any alcohol remaining in the mouth or saliva takes this long to disperse and will interfere with the reading.
-
- Avoid testing in a strong wind or in a closed room with dirty air.
-
- When the "BATT LOW" LED is on, replace 9V alkaline battery.
-
- Do not blow smoke or liquid into the unit. It will damage the sensor. Wait 1 minute after smoking before a test.
-
- Although CA2000 analyzes alcohol level accurately, do not use it as a tool to drink and drive.
-
- Store the unit between 32-104 (°F) and out of the reach of children.
-
- Do not leave CA 2000 car adaptor hooked up to cigar jack.
-
- Do not teave CA 2000 requires calibration every 12 months to obtain accurate results. Discuss with local distributors for calibration.
Troubleshooting
Replace the battery if the BATT LOW lamp comes on. Refer other problems to the toll free number below. No user serviceable components inside. Attempting to service the unit yourself voids the warranty.
Cleaning Instructions
For sanitation reasons, replace plastic mouthpiece if another person is going to use the unit. r of samation readsen topiated with a damp cloth. Do not submerge in water. This will void the warrantee. No routine maintenance other than yearly calibration is required.
Specifications
| Dimensions: | 4.7 x 2.4 x 1" | Weight | 1.5 oz. |
|---|---|---|---|
| Battery: | 9V alkaline | Operating Temp. | 50 -104° F |
| Sensor: | Highly selective semi-conductor oxide sensor | Warm-up time | 20 sec |
| Response time | 5 sec | Accuracy | ±0.01 % at 0.10% BAC |
| Calibration | BAC simulator | Calibration Interval | 1 year |
Warranty
We, warrant the product to be free from defects in workmanship or material for 1 year in normal service from the date of purchase. Our duty under this warranty is limited to replacing, or repairing the unit if returned along with proof of purchase. This warranty is void if unit has been tampered by the user. Refer problems to the toll free number below.
| Calibration: | Distributed by: |
|---|---|
| To recalibrate your alcohol tester, send it to this address: | KHN Solutions LLC |
| CA-2000 Calibration Center | 1136 Montgomery Street |
| 12441 West 49th Ave/#4 | San Francisco, CA 94133 USA |
| Wheat Ridge, CO 80033 | Phone: (415) 693-9756 |
| Please include a check or money order for $19.95 made | Toll-Free 1-877-334-6876 |
| payable to Lifeloc Technologies Inc. Your tester will be | Fax: (415) 693-0215 |
| returned within 10 days. | Email: info@breathalyzer.net |
| Made in Korea |
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Image /page/4/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 three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 1 2004
KHN Solutions, LLC c/o Mr. Daniel Kamm Kamm and Associates PO Box 7007 Deerfield, IL 60015
K041334 Re: K041334
Trade/Device Name: AlcoMate CA2000™ Digital Alcohol Detector Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: May 18, 2004 Received: May 20, 2004
Dear Mr. Kamm
We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 510(x) premained historially equivalent (for the indications referenced above and nave uccemined the actrice as redicate devices marketed in interstate for use stated in the encrosule) to regally manated producal Device Amendments, or to commerce prior to May 28, 1770, the enastnent assist of the Federal Food. Drug, Drug, devices that have been recurse in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicatio and Cosmelle Act (Act) that to not require approvise in the general controls provisions of the Act. The You may, merelore, market the devices, babject to the mements for annual registration, listing of general controls provisions of the Fist labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (350 a00 v) into existing major regulations affecting your device It may be subject to such additional controllar Blassing in the same of to 895. In addition, FDA Can be found in Title 21, South of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a based.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal statutes and regulations, but not limited to: registration and listing (21 Comply with an the 11et 5 requirements 801 and 809); and good manufacturing practice CFR Part 8077, laboring in the quality systems (QS) regulation (21 CFR Part 820).
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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 premated 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Seain M. Cooper, MS, DVM.
Jean M. Cooper, MS, 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
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Revised
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: Intended to measure alcohol in the human breath. Measurements indications i or Secrite are used in the diagnosis of alcohol intoxication.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
X __ Over-The-Counter Use _ (21 CFR 807 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)
Allate Ciz
Division Sign-Off
Vision Sign-
Page 1 of 1
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K041334
§ 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.