(356 days)
Not Found
Not Found
No
The summary provides no indication of AI/ML technology, and the device description (instant thermometer) is typically a simple, non-AI device.
No
The device is described as a thermometer used to measure body temperature, which is a diagnostic function, not a therapeutic one.
Yes
Unknown
The provided text is a very brief summary and lacks sufficient detail about the device's components and how it measures temperature. It only provides the intended use and device name. Without a more comprehensive description, it's impossible to determine if it's software-only or includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "MEASURE A PERSON'S BODY TEMPERATURE." This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as a "QUICK CHECK INSTANT THERMOMETER." Thermometers are used for direct measurement of body temperature.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, based on the provided text, this device falls under the category of a general medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
THIS DEVICE IS INTENDED TO BE USED WHEN IT IS DESIRED TO MEASURE A PERSON'S BODY TEMPERATURE.
Product codes
FLL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 MAY
Mr. Jim Hastie ·VP, Marketing EJB Medical, Incorporated 250 El Camino Real, Suite 214 Tustin, California 92780
Re : K971831 Quick Check Instant Thermometer Trade Name: Requlatory Class: II Product Code: FLL April 8, 1998 Dated: Received: April 10, 1998
Dear Mr. Hastie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with --------------------------------------------------------------------------------------------------------------the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Hastie
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaffgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
P.2/2
S10(k) Number (if known): K971831
Device Name: QUICK CHECK INSTANT THERMOMETER
Indications For Use:
THIS DEVICE IS INTENDED TO BE USED PHIN IT IS DESIRED TO MEASURE & PERSON'S BODY TEMPERATURE. -
. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucenic
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K971831
Presention Use (Per 21 CFR 801,109)
OR
· Over-The-Counter Use __ I
(Optional Formal 1-2-96)