(24 days)
The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.
The provided text describes a 510(k) premarket notification for the Digene DML 2000 Microplate Luminometer. It outlines the device's description, intended use, and substantial equivalence to a predicate device. However, the document does not contain information related to acceptance criteria, specific performance studies, sample sizes, expert involvement, or ground truth establishment relevant for an AI/ML medical device.
The device described is a microplate luminometer, a laboratory instrument designed to measure light produced by chemiluminescent reactions. It is not an AI/ML-based device that would typically have acceptance criteria related to algorithmic performance metrics like sensitivity, specificity, or AUC, nor "studies" in the context of evaluating an AI model.
Therefore, I cannot provide the requested table and details because the provided document does not contain this type of information. The 510(k) summary focuses on demonstrating substantial equivalence of a physical laboratory instrument, not the performance of an AI/ML algorithm.
§ 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.