BACTI-SWAB DRY

K013711 · Remel Co. · LIO · Nov 26, 2001 · Microbiology

Device Facts

• Record ID: K013711
• Device Name: BACTI-SWAB DRY
• Applicant: Remel Co.
• Product Code: LIO · Microbiology
• Decision Date: Nov 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Indications for Use

REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.

Device Story

Bacti-Swab™ Dry is a sterile specimen collection and transport system consisting of a rayon-tipped plastic shaft swab housed in a plastic sleeve. Used by healthcare professionals in clinical settings to collect biological samples for subsequent microbiological laboratory analysis. The device facilitates the safe transport of samples while maintaining sterility until the point of laboratory processing. It serves as a mechanical tool for sample acquisition; no electronic, software, or algorithmic components are involved.

Clinical Evidence

No clinical data provided; device is a standard microbiological collection tool.

Technological Characteristics

Sterile, rayon-tipped plastic shaft swab; plastic sleeve housing. Class I medical device under 21 CFR 866.2900.

Indications for Use

Indicated for the collection and transport of clinical samples for microbiological examination in patients where dry swab collection is appropriate.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.

Public Health Service

NOV 2 6 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert E. Booth Vice President, Regulatory Affairs/Quality Assurance Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215

Re: K013711

Trade/Device Name: Bacti-Swab™ Dry Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological specimen collection and transport device Regulatory Class: I Product Code: LIO Dated: November 7, 2001 Received: November 7, 2001

Dear Mr. Booth:

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 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 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 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 regulation 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}------------------------------------------------

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 nontication. The I Dr Inising of Scation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 IT you desire specific advices in the other devices), please contact the Office of Compliance at additionally 607.10 for in The saggestions on the promotion and advertising of your device, [phone]. Traditionally, spirance at [phone]. 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 mionitation on Joan respondant Consumer Assistance at its toll-free number [phone] or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

remo

NOV 2 6 2001

K013711

Page I of I

K013711

510(k) Number (if known) Device Name

Bacti-Swah™ Dry

Indications for Use:

REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.

## PLEASE DO NOT WRIT BELOW THIS LINE-CONTINUEON ANOTHER PAGE IF NEEDED

Ludelia Poole

linical Laboratory Dev

Number K013711

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

12076 Santa Fe Drive, Lenexa, KS 66215 • 913-888-0939 • 800-255-6730 • Fax [phone]

Quality Microbiology Products and Service