(27 days)
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Not Found
No
The 510(k) summary describes a general-purpose disinfectant and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a general purpose disinfectant for inanimate environmental surfaces, not for use on or in the human body for therapeutic purposes.
No
Explanation: The device is described as a "general purpose disinfectant" used to clean surfaces, not to diagnose medical conditions in patients.
No
The intended use describes a general purpose disinfectant, which is a chemical substance, not a software device. The lack of any mention of software, algorithms, or digital processing further confirms it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces". This describes a product used to clean and sanitize surfaces, not to perform tests on biological samples (like blood, urine, tissue, etc.) to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples.
- Providing diagnostic information.
- Measuring analytes in biological specimens.
- Any components typically associated with IVD tests (reagents, calibrators, controls, etc.).
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This disinfectant does not fit that description.
N/A
Intended Use / Indications for Use
General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.
Product codes
LRJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental, medical, hospital, and veterinary facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human figures, represented by flowing lines, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Chemlink Laboratories LLC C/O Ms. Kari E. Mavian Agent for Chemlink Laboratories, LLC Lewis & Harrison 122 C Street, N.W. Suite 740 Washington, DC 20001
Re: K984485 Trade Name: Microstat 2™ Regulatory Class: Unclassified Product Code: LRJ Dated: December 16, 1998 Received: December 17, 1998
Dear Ms. Mavian:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq . Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Ms. Mavian
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/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
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Page 1 of 1
510(k) NUMBER (IF KNOWN): K984485
DEVICE NAME: Microstat 2
INDICATIONS FOR USE:
General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. }
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109)
OR
Over - The - Counter - Use (Optional
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _