Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms. Final order.

The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mass pectrometer system for clinical use for the identification of microorganisms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media. Final order.

The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated image assessment system for microbial colonies on solid culture media's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay. Final order.

The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; immunology and microbiology devices; classification of dengue virus serological reagents. Final order.

The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; immunology and microbiology devices; classification of Plasmodium species antigen detection assays. Final rule.

The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Microbiology devices; reclassification of hepatitis A virus serological assays. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays" that will serve as the class II special control for these devices.

Medical devices; immunology and microbiology devices; classification of ribonucleic acid preanalytical systems. Final rule.

The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing)." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

Medical devices; immunology and microbiology devices; classification of the endotoxin assay. Final rule.

The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

A computer program in QuickBasic for the selection of tests for the identification of Helicobacter pylori.

Reliable microbiological tests are needed for the identification of bacteria. A program has been written in QuickBasic to identify such tests by using a formula that is based on Gyllenberg's Sum of C(i) and Gyllenberg's Rank R(i). A total of 139 papers on a newly isolated bacterium, Helicobacter pylori, was used as data source for the coding of test results into an input file. The program outputs a list that aids in the determination of suitable tests for the identification of H. pylori. These tests chosen by the formula were found to be correctly identified as supported by later publications on the bacterium.

Levantamento de microorganismos termofilos esporulados sulfito-reutores (Desulfotomaculum nigrificans) em mostras de açucar refinado / The microoganisms termophyles sporuled reducing sulphite taking way (Desulfotomaculum nigrificans) in the refined samples

Foi realizado um levantamento de microorganismos termofilos esporulados sulfito redutores (Desulfotomaculum nigrificans) em 18 amostras de acucar refinado obtidas de diversos estabelecimentos. Os resultados revelaram a presenca de desulfotomaculum nigrificans em 13 (72 por cento ) das 18 amstras analisadas.Das 13 amostras que apresentavam Desulfotomaculum nigrificans, somente 11 delas (61 por cento ) estavam em desacordo com o padrao proposto para este tipo de microorganismo que e de 5 esporos/10 gramas de produto.

Guidelines for the management of accidents involving microorganisms: a WHO memorandum.

The response to an emergency resulting from an accident involving microorganisms, whether in a laboratory or during needs to be graded according to the degree of hazard to human or animal health created by the circumstances of the accident and the properties of the organisms concerned. A categorization of microorganisms by risk groups is proposed for the purposes of accident management, and the factors influencing assignment to risk groups are described. Organizational responsibilities at government health authority and local levels are outlined and emphasis is placed on contingency planning. Medical surveillance is proposed for persons who work in laboratories with dangerous microorganisms, as a means of recognizing accidents that might otherwise go undetected. The response to exposure in a laboratory or transport-associated accident includes emergency safety measures at the site, hazard assessment, and action by the public health or veterinary authorities. The management of exposed persons is considered in relation to the immediate post-exposure period, the potential incubation period, and the onset of illness. Prophylactic treatment, surveillance, and the transport and isolation of infected persons are described. A distinction is drawn between the consequences of accidents recognized at the time of their occurrence and those that are only recognized by onset of illness in the exposed persons.