(66 days)
Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
Not Found
This is a 510k document for the AllergEAZE™ Patch Test Chambers. This document is a clearance letter from the FDA, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. This letter does not describe a clinical study or performance evaluation in the way a scientific paper or a more detailed regulatory submission might.
The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate, rather than presenting a detailed performance study with acceptance criteria and a study design.
§ 880.6025 Absorbent tipped applicator.
(a)
Identification. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.(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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.