(55 days)
Not Found
No
The description focuses on standard infrared sensor technology and an ASIC for signal processing, with no mention of AI or ML terms or concepts.
No
The device is an infrared thermometer used for temperature measurement, which is a diagnostic tool, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures temperature, which can be a sign but doesn't diagnose a condition. It is explicitly stated as a reference tool.
No
The device description explicitly states it is a "hand held, reusable, battery operated, maximum device" and describes hardware components like an "infrared sensor" and "ASIC" that convert signals to digital values for display on an "LCD". This indicates it is a physical hardware device, not software only.
Based on the provided information, the ThermoFlash LX-26 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for measuring body surface and forehead temperature. This is a direct measurement of a physiological parameter of the living body.
- Device Description: The device description confirms it's an infrared thermometer for measuring human body temperature.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ThermoFlash LX-26 does not interact with or analyze any such specimens.
Therefore, the ThermoFlash LX-26 is a medical device, but it falls under the category of a non-invasive thermometer rather than an IVD.
N/A
Intended Use / Indications for Use
ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR sensor to digital value and display it by LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface and forehead
Indicated Patient Age Range
Infants and adults
Intended User / Care Setting
Consumers in household environment and doctor in clinic
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 device conforms to applicable standards included ASTM E 1965-98(2003). IEC 60601-1 and IEC 60601-1-2 requirements.
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
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
510(K) SUMMARY
MAY 12 2008
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92
1.0 Submitter's Information
| Name: | JXB Co, LTD Guangzhou (China) |
|---|---|
| Address: | Nº 38 Huanzhen Xi Road, Dagang Town,Panuy, Guangzhou, China |
| Phone: | +86-20-34936960 |
| Fax: | +86-20-34936960 |
| Contact: | Tray Cui |
| Email: | Trayhtb@hotmail.com |
2.0 Device Information
| Name: | Infrared Thermometer |
|---|---|
| Trade Name: | ThermoFlash LX-26 |
| Model: | ThermoFlash LX-26 |
Classification 3.0
| Product Code: | FLL---clinical electronic thermometer |
|---|---|
| Regulation: | 880.2910 |
| Number: | |
| Classification: | II |
| Panel: | 80 |
Predicate Device Information 4.0
| Sponsor: | Famidoc Technology Co., Ltd |
|---|---|
| Device: | Infrared Thermometer, Model: FDIR-V1 |
| 510(K) Number: | K052849 |
5.0 Device description
Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead
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temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when mcasuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR schsor to digital value and display it by LCD.
6.0 Intended Use
ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
7.0 Performance Summary
The device conforms to applicable standards included ASTM E 1965-98(2003). IEC 60601-1 and IEC 60601-1-2 requirements.
Comparison to predicate device and conclusion 8.0
Our Infrared Thermometer ThermoFlash LX-26 is substantially equivalent to Infrared Thermometer, Model: FDIR-V1 whose 510(K) number is K052849.
The two devices are very similar in design principle, intended use, functions, material and the applicable standards. Only their outlook and some parameter such as measurement rang are different. However, the tests in this submission provide demonstration these small differences do not raise any new question of safety or effectiveness.
2
The infrared thermometer ThermoFlash LX-26 is substantially equivalent to the predicate device.
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- 9.0 Draft date: June 21, 2007
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 12 2008
JXB Company, Limited Guangzhou C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K080759
Trade/Device Name: ThermoFlash LX-26 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 25, 2008 Received: April 28, 2008
Dear Mr. Conry:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Conry
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the Underwriters Laboratories Inc. logo. The logo consists of the letters "UL" inside of a circle on the left. To the right of the circle are the words "Underwriters Laboratories Inc." in bold black font. The logo is a registered trademark.
Statement of Indications for Use
510(k) Number (if known):
Device Name: ThermoFlash LX-26
Indications For Use:
ThermoFlash LX-26 is an infrared thermometer for body surface and forellead temperature measurement for infants and adults without contact to human body.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cim 200
Page 15 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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