Clinical Accuracy Study for Infrared Thermometer

A clinical study will be conducted on the Infrared Thermometers to verify whether its clinical accuracy (clinical bias, limits of agreement, and clinical repeatability) meets the standard requirements.

Study Overview

• Status: Completed
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Infrared Thermometer; Device: Electronic Thermometer

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Handan, Hebei, China
      • Handan Maternal and Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged 0-1 year, 1-5 years, or >5 years, regardless of gender;
2. The subject or/and their guardian consents and signs the Informed Consent Form.

Exclusion Criteria:

1. Premature infants with a gestational age of less than 37 weeks and low-birth-weight infants (birth weight less than 2.5kg); this item applies only to subjects aged 0-3 months;
2. Life-threatening acute infections;
3. Subjects who have taken a bath, sponge bath, applied hot/cold compresses, eaten, cried restlessly, or engaged in strenuous exercise within 30 minutes before the trial;
4. Subjects who have taken antipyretics within 180 minutes before the start of the measurement;
5. Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infrared Thermometer; Infrared Thermometer is produced by Contec Medical Systems Co., Ltd.	Device: Infrared Thermometer; The test data are based on the data displayed by the infrared thermometer developed and manufactured by CONTEC Medical Systems Co., Ltd.
Other: Electronic Thermometer; Electronic Thermometer produced by JOYTECH HEALTHCARE CO. LTD.	Device: Electronic Thermometer; The test data is based on the data displayed by the electronic thermometer developed and manufactured by joytech healthcare Co. Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical bias and limits of agreement	Mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured from selected group of subjects.	Baseline
Clinical repeatability	Pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT TEMPERATURES taken from the same subject at the same MEASURING SITE with the same CLINICAL THERMOMETER by the same OPERATOR within a relatively short time	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance evaluation	It is evaluated by the investigator using the test device, including operational satisfaction, working stability, and performance failures.	Baseline
Device defects	Device defects refer to unreasonable risks that may endanger human health and safety when medical devices are used normally during clinical trials, such as label errors, quality issues, and malfunctions. During the trial, closely observe the performance and safety of the test device, and monitor whether the test device has quality problems, malfunctions, or other defects, and whether these problems endanger the health or safety of the subjects.	Baseline

Collaborators and Investigators

• Sponsor: Suzhou Care-Real Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Actual): April 9, 2026
• Study Completion (Actual): April 9, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Temperature Changes
• Other Study ID Numbers: TP600-CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No