CITREX HOSPITAL SPRAY DISINFECTANT

K982985 · Caltech Industries, Inc. · LRJ · Nov 2, 1998 · General Hospital

Device Facts

• Record ID: K982985
• Device Name: CITREX HOSPITAL SPRAY DISINFECTANT
• Applicant: Caltech Industries, Inc.
• Product Code: LRJ · General Hospital
• Decision Date: Nov 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

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).

Device Story

CITREX® Hospital Spray Disinfectant; intermediate-level disinfectant/cleaner; intended for non-critical medical equipment and hard surfaces (stainless steel, porcelain) in healthcare environments; functions via chemical disinfection; requires one-minute contact time at room temperature (20-25°C); aids in environmental control of bacteria to prevent cross-contamination; applied by healthcare personnel; OTC use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Chemical disinfectant spray; intended for hard surfaces including stainless steel and porcelain; intermediate-level disinfection; requires 1-minute contact time at 20-25°C.

Indications for Use

Indicated for use as a general-purpose intermediate level cleaner/disinfectant for non-critical medical equipment surfaces and hard surfaces (stainless steel, porcelain) in healthcare settings to control bacterial cross-contamination.

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)