(112 days)
THE ALPHA 4 LS IS INTENDED TO AUTOMATE MICROTITER PLATE PROCESSOR AND READER THAT MEASURES THE LIGHT ABORBANCE OR LUMINESCENCE OF REACTION PRODUCTS IN EITHER MODE.
ALPHA 4 LS Automated Microtiterplate Processor and Reader
This document is a 510(k) clearance letter from the FDA for the "Alpha 4 LS Automated Microtiterplate Processor and Reader". It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the 510(k) submission itself, which is not provided here.
Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study proving the device meets them based solely on the provided text. The document is essentially a regulatory approval letter, not a technical performance report.
§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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 § 862.9.