(68 days)
Not Found
Not Found
No
The 510(k) summary describes a disinfectant spray and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a general-purpose intermediate-level disinfectant for environmental control of bacteria on non-critical devices and hard surfaces, not for treating diseases or conditions.
No
Explanation: The device is a disinfectant, used for cleaning and disinfecting surfaces, not for diagnosing medical conditions.
No
The device is a disinfectant spray, which is a chemical substance and not a software application. The description clearly indicates its use for cleaning and disinfecting surfaces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for disinfecting surfaces of non-critical medical devices and hard surfaces in healthcare settings. This is an environmental control measure, not a diagnostic test performed on biological samples.
- Lack of Diagnostic Activity: The description focuses on killing bacteria on surfaces, not on analyzing biological samples (like blood, urine, tissue) to diagnose a disease or condition.
- No Mention of Biological Samples: There is no mention of collecting, processing, or analyzing any biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The CITREX® HOSPITAL SPRAY DISINFECTANT does not fit this definition.
N/A
Intended Use / Indications for Use
CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
Product codes
LJR
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
healthcare settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(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 § 880.9.
0
Image /page/0/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the left and the letters 'DE' on the right. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight. The letters 'DE' are in a simple, sans-serif font and are positioned to the right of the bird symbol. The logo appears to be a simple and clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 NOV
Mr. Gregory S. Cross Environmental Chemist Caltech™ Industries, Incorporated 2420 Schuette Drive Midland, Michigan 48642
K982985 Re : CITREX® Hospital Spray Disinfectant Trade Name: Regulatory Class: Unclassified Product Code: LJR Dated: Auqust 21, 1998 Received: August 26, 1998
Dear Mr. Cross:
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 be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Cross
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 requlation (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
مَ مَ سَاسْتَهِ الْسَتَّهِ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَوْةِ الْأَمْرُ الْأَمْرُ الْأَمْرَةِ الْأَمْرَ
Page
510(k) Number (if known): K982985
Device Name: _CITREX® HOSPITAL SPRAY DISINEECTANT
Indications For Use:
CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)