(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.
§ 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.