(19 days)
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.
comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve
This is an FDA Premarket Notification (510(k)) letter for a microbiological specimen collection and transport device, the Bacti-Swab™ Dry. Based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for this device.
The letter explicitly states:
- "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..."
- "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 device is an authorization for your device and thus, permits your device to proceed to the market."
This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a new clinical performance study demonstrating specific acceptance criteria with detailed performance metrics. The 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new clinical trials that would generate the type of data you're asking for.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, or performance because that information is not present in the provided FDA letter. The letter is a clearance notification, not a study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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, (301) 594-4566. Traditionally, spirance 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 mionitation on Joan respondant Consumer Assistance at its toll-free number (800) 638-2041 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
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remo
NOV 2 6 2001
Page I of I
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 913-888-5884
Quality Microbiology Products and Service
§ 866.2900 Microbiological specimen collection and transport device.
(a)
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.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.