(257 days)
The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.
The product is a plastic tray with shallow indentations or chambers for use as a place allergens or allergen mixes in contact with the surface of the skin during allergen patch tests.
The provided documents pertain to the 510(k) premarket notification for the "IQ Chamber," an allergen delivery system. The initial FDA letter in 2000 determined the device to be substantially equivalent. A later letter in 2024 updated the product code.
However, the documents do not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, ground truth establishment, or any performance metrics that would typically be found in a study demonstrating a device meets acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device, not on presenting a performance study with acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The documents describe the device and its intended use, and state that it was found substantially equivalent to predicate devices, but they do not disclose the studies or data used to support thisequivalence or any specific performance criteria.
§ 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.