(66 days)
Not Found
No
The description focuses on the electrochemical fuel cell sensor and the transmission of results, with no mention of AI or 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 treatment or prevention of any disease or condition.
Yes
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 that the device uses an electrochemical fuel cell sensor to measure alcohol in the breath, which is a hardware component.
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 by this device are used in the diagnosis of alcohol intoxication. This is a key characteristic of an IVD device.
- Device Description: The device measures alcohol in the human breath, which is a biological sample. IVD devices analyze biological samples to provide information for diagnosis.
While the device description doesn't explicitly use the term "in vitro," the analysis of breath (a biological sample) for diagnostic purposes (alcohol intoxication) aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X are intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle.
The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth (intended for deep lung air for measurement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, In public / General Public
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)
Product bench testing indicates substantial equivalence to both predicate devices. The comparison testing of the Intoxilyzer S-D5 DOT approved device, the AlcoMate comparison teating of aint Systems BreathKey M Model g10 and BreathKey™ Model g30X with the inclusion of DOT requirements indicate equivalence to the predicates regarding safety and efficacy.
A clinical trial designed to assess user readability and understandability of the Operation Manual show safety regarding consumer use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.0014% BAC @ 0.80%
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), OmegaPoint Systems Personal Breath Alcohol Tester
DEC 9 2005
Image /page/0/Picture/3 description: The image shows the text "K052 804" written in black ink on a white background. The text appears to be handwritten and has a slightly slanted orientation. A gray bar is located underneath the text.
16. 510(k) Summary
Date
July 29, 2005
Owner
OmegaPoint Systems, LLC Ed Gollar 1077 Celestial Street Suite 400 Cincinnati, OH 45202 Telephone: 513-241-7540 513-241-7050 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Trade Name
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X
Common Name
Device, Breath Trapping Alcohol Medical Specialty: Toxicology Product Code: DJZ 862.3050 21 CFR:
Predicate Device(s)
AlcoMate CA2000 Digital Alcohol Detector manufactured by KHN Solutions LLC 510(k) Premarket Notification number: K041334 FDA Product Code: DJZ
Intoxilyzer S-D5, manufactured by CMI, Inc DOT approved device 69 FR 42237 (See Appendix 1.0)
Device Description
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle.
The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
OmegaPoint Systems, LLC Proprietary and Confidential Information 1077 Celestial Street; Cincinnati, OH 45202 July 29, 2005
1
Intended Use
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X are intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
Substantial Equivalence Conclusion
Product bench testing indicates substantial equivalence to both predicate devices. The comparison testing of the Intoxilyzer S-D5 DOT approved device, the AlcoMate comparison teating of aint Systems BreathKey M Model g10 and BreathKey™ Model g30X with the inclusion of DOT requirements indicate equivalence to the predicates regarding safety and efficacy.
A clinical trial designed to assess user readability and understandability of the Operation Manual show safety regarding consumer use of the device.
2
| Summary of Substantial Equivalence | AlcoMate | Professional | OmegaPoint Personal |
|---|---|---|---|
| Feature | CA2000 K041334 | Intoxilyzer Model | |
| S-D5, Evidential | |||
| Breath Alcohol | |||
| Device | Breath Alcohol Tester | ||
| Model g10 and Model | |||
| g30X | |||
| Indication for USE | Measure alcohol in | ||
| the human breath. | |||
| Measurements | |||
| obtained by this | |||
| device are used in | |||
| the diagnosis of | |||
| alcohol | |||
| intoxication. | Determining | ||
| breath alcohol | |||
| level | Determining breath | ||
| alcohol level. | |||
| Measurements obtained | |||
| by this device are used | |||
| in the diagnosis of | |||
| alcohol intoxication. | |||
| BreathKeyTM Model | |||
| g30X transmits the BAC | |||
| results to an interlock | |||
| receiver installed in a | |||
| motor vehicle. | |||
| Intended User | General Public | Law enforcement | General Public |
| Where Used | Home, In public | Police cruiser, | |
| police station | Home, In public | ||
| Construction | Plastic case with | ||
| internal circuit | |||
| board, display, | |||
| internal circuitry | |||
| with ethanol | |||
| sensor | Plastic case, | ||
| button, display, | |||
| internal circuitry | |||
| with | |||
| microprocessor, | |||
| and ethanol sensor | Plastic case, button, | ||
| display, internal | |||
| circuitry with | |||
| microprocessor, and | |||
| ethanol sensor | |||
| Sensor | Semi-conductor- | ||
| Oxide Sensor | Electrochemical | ||
| fuel cell | Electrochemical fuel | ||
| cell | |||
| Size | 3 ½"W x 5"H | 2 ½"W x 4 ¾"H x | |
| 1 ¼"D | 1 3/8"W x 2 3/8"H x | ||
| 9/16"D | |||
| Weight | 200 grams | 120 grams | 20 grams |
| Sampling Time | 5 sec | 4 sec | 4 sec |
| Mouthpiece | Replaceable | Replaceable | Integral |
| Power Source | 9 Volt Alkaline | ||
| Battery, | |||
| replaceable | 2 AAA batteries, | ||
| replaceable | 3V lithium battery, | ||
| permanent | |||
| Warm-up Time | 20 sec | 20 sec | 3 sec |
| Display | 3 Digit LED | 3 Digit LED | 3 Digit and 4 Characters |
| LCD | |||
| Accuracy | +/- 0.01% BAC @ | ||
| 0.10% | 0.005% BAC @ | ||
| up to 0.10% | +/- 0.0014% BAC @ | ||
| 0.80% | |||
| Measurement Site | Mouth | Mouth | Mouth |
| MODE | Breath Alcohol | ||
| Concentration | Breath Alcohol | ||
| Concentration | Breath Alcohol | ||
| Concentration | |||
| Measurement Range | 0.00 - 0.40% | 0.00 - 0.40% | 0.000 - 0.200% |
| DOT Approval | YES | YES | NO |
of Substantial Equivalence C
OmegaPoint Systems, LLC Proprietary and Confidential Information 1077 Celestial Street; Cincinnati, OH 45202 July 29, 2005
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized symbol with three curved lines, resembling a person embracing another person. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OmegaPoint Systems, LLC c/o Ewe Degenhardt TUV America 10040 Mesa Rim Road San Diego, CA 92121
2005 DEC #
K052804 Re:
Trade/Device Name: OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and Breathkey™ Model g30X
Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: December 7, 2005 Received: December 8, 2005
Dear Mr. Degenhardt:
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).
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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 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) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, 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
Specifications for the Laser
K 052804 510(k) Number (if known):
Device Name:
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey M Model g10 and BreathKey 10 Model g30X
Indications for Use:
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
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)
ce of In Vitro E evice Evaluatio
.510(k) K 052804