(74 days)
Not Found
No
The description focuses on a fuel cell sensor and standard calibration procedures, with no mention of AI/ML algorithms for data processing or interpretation.
No.
The device is used for diagnosis of alcohol intoxication by measuring alcohol in human breath, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description explicitly states it is a "Breathalyzer" and describes hardware components like batteries and a fuel cell sensor.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained are used in the diagnosis of alcohol intoxication. This is a key characteristic of an IVD device, as it's used to provide information for diagnostic purposes.
- Sample Type: The device measures alcohol in human breath. While breath is not a traditional "in vitro" sample like blood or urine, regulatory bodies often classify devices that analyze bodily fluids or substances expelled from the body for diagnostic purposes as IVDs.
- Device Description: The description reinforces its purpose as an "alcohol screening device" that provides a digital result indicating approximate BAC, which is directly related to diagnosing alcohol intoxication.
Therefore, the combination of the intended use for diagnosis and the analysis of a human bodily substance (breath) strongly indicates that this device falls under the category of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
"The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month."
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 results of bench, test laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate devices."
"The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.01 %BAC @ 0.02 %BAC
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
510(k) Summary 510(k) Number K090067 KHN Solutions LLC 300 Broadway, Suite 26 San Francisco, CA 94133 Phone: 415-693-9756 Fax: 415-358-8030 Email: info@khnsolutions.com Contact: Keith Nothacker, President Date Prepared: February 11, 2009
-
- Identification of the Device: Proprietary-Trade Name: Bactrack@ Select Breathalyzer Model S80 Classification Name/Product Code: Devices, breath trapping, alcohol, DJZ Common/Usual Name: Breath Alcohol Tester
- Equivalent legally marketed device: AlcoHAWK PT500 K080848 Q3 Innovations LLC. 2.
-
- Indications for Use (intended use) This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
-
- Description of the Device: The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
6. Substantial Equivalence Chart
| Feature | AlcoHAWK PT500 K080848 Q3
Innovations LLC | BACTRACK® Select
Breathalyzer: S80 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| INDICATION OF USE | This device is intended to measure
alcohol in the human breath.
Measurements obtained by this
device are used as an aid in the
detection of alcohol intoxication. | SAME |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| Blowing time | 5 Seconds | SAME |
| Response time | 3 Seconds | SAME |
| DISPLAY | 4 digit LCD with backlight
(orange) | SAME, backlight is green |
| POWER SOURCE | 2 - AA Alkaline | SAME |
| BATTERY LIFE | 200 tests | Up to 1500 tests |
| Measurement Range | 0.000% to 0.400% BAC | SAME |
| Accuracy | $\pm$ 0.01% BAC at 0.10% BAC | +/- 0.01 %BAC @ 0.02 %BAC |
| TYPE OF SENSOR | Fuel cell electrochemical sensor | SAME |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable, polystyrene | SAME |
| Warm Up Time | 10-20 seconds | SAME |
| DOT | DOT Approved | Meets DOT requirements |
| Construction | Plastic case with internal circuit
board | SAME |
| SIZE | 5" x 2.63" x 1.25"
(12.7 cm x 6.68 cm x 3.18 cm) | 2.3 x 4.8 x 0.8 inches
(5.8 x 12.2 x 2.2 cm) |
| WEIGHT | 3.6 oz (102 g) without batteries;
5.2 oz (147 g) with batteries | 4.8 oz (136 g) with mouthpiece
and batteries |
| Operating temperature | 10 - 40°C (50 - 104°F) | SAME |
- Conclusion. After analyzing bench tests, laboratory tests, a risk analysis, EMC, and clinical testing data, it is the conclusion of KHN Solutions that the BACTRACK® Select Breathalyzer 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. The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle, emphasizing the department's name and its national scope.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 4 2009
KHN Solutions, LLC c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield. IL 60015
K090067 Trade/Device Name: Bactrack® Select Breathalyzer Model S80 Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I, reserved Product Code: DJZ Dated: January 5, 2009 Received: January 9, 2009
Dear Mr. Kamm:
Re:
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).
3
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 (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.
Cout C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indications for Use KOGODIa 7 510(k) Number (if known): K08
Device Name: Bactrack® Select Breathalyzer Model S80
Indications For Use:
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (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)
Sign-Off
Cice of In Vitro Diagnostic Device funtion and Safety
080067
Page 1 of 1