MLX MICROTITER PLATE LUMINOMETER

K962265 · Dynatech Laboratories, Inc. · JSE · Jul 25, 1996 · Microbiology

Device Facts

• Record ID: K962265
• Device Name: MLX MICROTITER PLATE LUMINOMETER
• Applicant: Dynatech Laboratories, Inc.
• Product Code: JSE · Microbiology
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2320
• Device Class: Class 1

Intended 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.

Device Story

Benchtop microplate luminometer; measures light emission from bioluminescent/chemiluminescent samples in microtiter plates. Operated by laboratory personnel in clinical/research settings. Device performs defined test protocols; processes light signals; outputs test results in user-selected formats. No direct patient contact; no therapeutic function. Revelation software manages test protocols and data processing. Healthcare providers use output for diagnostic or research analysis.

Clinical Evidence

No clinical data. Bench testing and hazard assessment performed to demonstrate conformance to standards and device specifications.

Technological Characteristics

Microplate luminometer; light detection system for bioluminescent/chemiluminescent reactions. Includes Revelation software for protocol management and data output. Benchtop form factor. Conforms to safety and environmental standards for laboratory instrumentation.

Indications for Use

Indicated for laboratory use to measure light emission from bioluminescent and chemiluminescent samples in microtiter plates. No direct patient contact or therapeutic function.

Regulatory Classification

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.

Predicate Devices

• Dynatech ML3000 (K923456)
• Dynatech ML2250 (K915896)

Submission Summary (Full Text)

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DYNATECH LABORATORIES
First in Microtiter Technology
K962265
JUL 25 1996

# Attachment 8:

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.


Dynatech Laboratories, Inc.
14340 Sullyfield Circle, Chantilly, Virginia 22021 USA
[phone], Fax [phone]