(24 days)
Not Found
Not Found
No
The device is a liquid germicidal detergent for disinfection, with no mention of AI or ML in the description or performance studies.
No
The device is a disinfectant intended for cleaning and disinfecting surfaces in healthcare settings, not for treating diseases or conditions in patients.
No
This device is a disinfectant, not a diagnostic device. Its intended use is for cleaning and disinfection of surfaces and medical devices, and its efficacy tests demonstrate its ability to kill bacteria, viruses, and fungi. There is no information suggesting it is used to diagnose diseases or conditions.
No
The device description clearly indicates a liquid germicidal detergent, which is a chemical substance, not software. The intended use and performance studies also describe the efficacy of this chemical product for disinfection.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the disinfection of hard, non-porous surfaces of medical devices and in healthcare settings. This is a cleaning and disinfection function, not a diagnostic one.
- Device Description: The description reinforces its use as a germicidal detergent for cleaning, disinfecting, and deodorizing surfaces.
- Performance Studies: The performance studies focus on its efficacy against bacteria, viruses, and fungi on surfaces, not on analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.
Product codes (comma separated list FDA assigned to the subject device)
LRJ
Device Description
Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.
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
Hospitals, nursing homes, and other health care institutions.
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)
Efficacy tests have demonstrated that this product is an effective bactericide, and virucide in the presence of organic soil (5% blood serum). When used as directed, Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Mycobacterium tuberculosis (BCG) at 20℃, Staphylococcus aureus, Salmonella cholerasuis, and Pseudomonas aeruginosa. Low pH Phenolic 256 is fungicidal against the pathogenic fungi, Trichophyton mentagrophytes (Athlete's Foot Fungus) when used as directed on hard surfaces found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet. This product, when used on environmental, inanimate, non-porous surfaces, exhibits effective virucidal activity against HIV-1 (associated with AIDS).
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.
Not Found
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
§ 880.6890 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/0 description: The image shows a logo with the text "CENTRAL SOLUTIONS INC" in bold, black letters. Above the text is a black circle with a white teardrop shape inside. To the right of the logo, the text "NOV 6 1998" is printed in a smaller, less bold font.
DISINFECTANT CATEGORY:
FRHOFF RD. KANSAS 66115
Formulation . Development . Production
510(k) SUMMARY
1983585
| SUBMITTER: | Central Solutions, Inc.
3130 Brinkerhoff Road
P.O. Box 15276
Kansas City, KS 66115
Tel: (913) 621-6542 | CONTACT PERSON: | Paul Nobrega |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------|
| | | DATE PREPARED: | August 27, 1998 |
| DEVICE TRADE / PROPRIETY NAME: | | Low pH Phenolic 256 | |
| DEVICE COMMON / USUAL NAME: | | General Purpose Disinfectant | |
| CLASSIFICATION NAME: | | Unclassified | |
This product is not to be used as a terminal sterilant/high-level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical medical devices prior to sterlization or high-level disinfection.
Intermediate Level General Purpose Disinfectant
USE, FUNCTIONS, CONCEPTS, AND PERFORMANCE CHARACTERISTICS OF DEVICE:
Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.
Efficacy tests have demonstrated that this product is an effective bactericide, and virucide in the presence of organic soil (5% blood serum). When used as directed, Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Mycobacterium tuberculosis (BCG) at 20℃, Staphylococcus aureus, Salmonella cholerasuis, and Pseudomonas aeruginosa. Low pH Phenolic 256 is fungicidal against the pathogenic fungi, Trichophyton mentagrophytes (Athlete's Foot Fungus) when used as directed on hard surfaces found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet. This product, when used on environmental, inanimate, non-porous surfaces, exhibits effective virucidal activity against HIV-1 (associated with AIDS). HIV-1 (AIDS Virus) on pre-cleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virus Type-1 (HIV-1) (associated with AIDS).
1
Image /page/1/Picture/0 description: The image shows the logo for Central Solutions, Inc. The logo consists of a stylized letter "C" with a water droplet inside. The text "CENTRAL SOLUTIONS, INC." is written in bold, sans-serif font below the logo.
3130 BRINKERHOFF RD. P.O. BOX 15276 KANSAS CITY, KANSAS 66115 (913) 621-6542
Formulation • Development • Production
510(k) Summary - Page 2
SCIENTIFIC PHYSICAL CHARACTERISTICS OF DEVICE:
| Product Designation: | Activated Synthetic Phenolic Base Disinfectant Cleaner |
|---|---|
| Appearance (Concentrate): | Clear light amber liquid |
| Odor: | Slight alcohol |
| Percent of Phenolics: | Concentrate: 14.735% |
| pH (concentrate): | 2.25 ± 0.50 |
| pH (use-dilution): | 3.50 ± 0.50 |
| Specific Gravity (25°C): | 1.089 ± 0.01 |
| Flash Point: | None |
| Detergency: | Excellent |
| Phosphate Content: | None |
| Testing: | A.O.A.C. in Hard Water up to 400 ppm in the presence of |
| 5% organic soil load |
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Paul J. Nobrega Registration Specialist Dental Solutions, Incorporated 3130 Brinkerhoff Road P.O. Box 15276 Kansas City, Kansas 66115
Re : K983585 Trade Name: Low pH Phenolic 256/Cen-pHene Regulatory Class: Unclassified Product Code: LRJ Dated: Auqust 27, 1998 October 13, 1998 Received:
Dear Mr. Nobrega:
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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
3
Page 2 - Mr. Nobrega
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 findinq 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" (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
4
Page _ 1 _ of _ 1
| Labels | Values |
|---|---|
| 510 (K) NUMBER (IF KNOWN) | K983585 |
| DEVICE NAME | LOW PHPHENOLIC 258/CEN-PHENE |
INDICATIONS FOR USE :
Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The Counter-Use Prescription Use (Per 21 CFR 801 。 109) (Optional Format 1 - 2 -96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _