(43 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". While the software is mentioned, there is no indication of AI/ML functionality.
No
The device measures light from reactions and performs test protocols; it does not treat or alleviate a medical condition.
No
The device measures light from reactions and performs test protocols, but it does not claim to diagnose any condition or disease. Its function is to provide raw data in various output formats.
No
The device description explicitly states that the MLX is a "Microtiter® Plate Luminometer" which measures light. This indicates a physical hardware device, not a software-only device, even though it incorporates software.
Based on the provided information, the MLX device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the MLX "measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results." This describes a device used to analyze samples in vitro (outside the body) to obtain information about those samples.
- Device Description: The description reinforces the intended use by stating it "measures the light emitted from bioluminescent and chemiluminescent reactions samples."
- Predicate Devices: The listed predicate devices (Dynatech ML3000 and ML2250) are also luminometers used for similar purposes, which are typically classified as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the function of measuring light from reactions in samples for the purpose of obtaining test results is the core definition of an IVD.
N/A
Intended Use / Indications for Use
The MLX measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The MLX Microtiter® Plate Luminometer ("MLX"). The Revelation software incorporated in the MLX was developed and manufactured in accordance with comprehensive software development, validation and verification procedures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing demonstrates the proper operation of the MLX in accordance with device specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.2320 Differential culture medium.
(a)
Identification. A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.(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 § 866.9.
0
Image /page/0/Picture/0 description: The image shows the Dynatech Laboratories logo. The logo consists of a stylized graphic on the left and the text "DYNATECH LABORATORIES" on the right. Below the text is the phrase "First in Microtiter' Technology" in a smaller font. The graphic is a black abstract design.
Attachment 8:
ur 2 5 1996
Summary of Safety and Effectiveness for Dynatech Laboratories, Inc.'s MLX Microtiter® Plate Luminometer
Dynatech Laboratories, Inc. ("Dynatech"), located in Chantilly, Virginia 22021, manufactures and distributes the MLX Microtiter® Plate Luminometer ("MLX"). The MLX is substantially equivalent to other currently marketed microplate luminometers that have received 510(k) premarket notification clearance. Specifically, the MLX is substantially equivalent to the Dynatech ML3000(K923456) and ML2250(K915896) microplate luminometers. The MLX and the predicate luminometers have identical intended uses and there are no differences in technological features that raise new or different issues regarding safety or effectiveness. Under no circumstances does the MLX have any direct patient contact or otherwise perform any therapeutic patient function, The MLX measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results.
The Revelation software incorporated in the MLX was developed and manufactured in accordance with comprehensive software development, validation and verification procedures. Through this process Dynatech carefully controls each aspect of the development of software code for the device.
Safety and environmental testing have demonstrated and certified that the MLX conforms to current standards relevant to devices such as the MLX. A hazard assessment study has been MLX and has determined that all known hazards are adequately addressed by device design or user instructions.
Performance testing demonstrates the proper operation of the MLX in accordance with device specifications.
Larry Pool
Quality Assurance Manager
Dynatech Laboratories, Inc.
14340 Sullyfield Circle, Chantilly, Virginia 22021 USA (703) 631-7800, Fax (703) 631-7816