Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss 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 image processing device for estimation of external blood loss' 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.

Classification of semi-automated flare readings using the Kowa FM 700 laser cell flare meter in patients with uveitis.

PURPOSE: To propose a classification system to grade semi-automated flare readings and assess its correlation with clinical flare grading and also to explore the utility of an additional step in clinical flare assessment between grades 0 and 1. METHODS: Semi-automated flare readings from 103 eyes with uveitis were taken using the Kowa FM 700 laser flare meter and classified into two models (LFCM and LFCM_1), and introduction of a 0.5 step in flare grading was explored. RESULTS: Good correlation was present between the conventional SUN clinical flare and the proposed clinical classification for flare (weighted kappa (WK) = 89.64%, p < 0.001). Semi-automated flare grading (LFCM and LFCM_1) had WK agreement of 82.52% and 79.85% (p < 0.001) with conventional SUN clinical flare grading. CONCLUSIONS: The proposed classification system for semi-automated laser flare readings (LFCM) allows stratification of measurements into grades analogous to clinical flare grades and correlates well with conventional clinical flare grading.

Estudio de hemolisinas del sistema ABO por técnica fotométrica simple en niños con ascariasis / Study of hemolysins of the ABO blood group system in children with ascariasis using a simple photometric technique

La heteroinmunización en el sistema ABO, a través de sustancias de origen animal o bacteriano, puede provocar la aparición de hemolisinas de importancia clínica en transfusión o embarazo. El objetivo de este trabajo era estudiar la presencia de hemolisinas ABO en niños con ascariasis utilizando una técnica fotométrica simple. Se trabajó con sueros de 23 niños (19 antes del tratamiento antiparasitario y 4 después). Se determinó el grupo sanguíneo ABO por técnicas convencionales. La técnica fotométrica usada para demostrar la presencia de hemolisinas ABO es una modificación del tiempo hemolítico (tH) 50. El tiempo hemolítico medido tiene significado clínico cuando es inferior a 300 segundos. El 57,89% de los sueros de los niños sin tratamiento presentó hemolisinas ABO, con tiempos hemolíticos comprendidos entre 100 y 210 segundos. Ninguno de los sueros de los niños tratados presentó hemolisinas ABO. Los resultados sugieren que la infección parasitaria puede ser el estímulo externo para la aparición de hemolisinas ABO. La técnica fotométrica usada es simple, rápida y accesible al laboratorio de rutina

Heteroimmunization in the ABO system by animal or bacterial products can provoke the development of hemolysins of clinical importance in transfusions or pregnancy. We proposed to study the presence of ABO hemolysins in children with ascariasis using a simple photometric technique. Serum samples were collected from 23 children (19 prior to and 4 after treatment with antiparasitic agents). The ABO blood group was determined by conventional techniques. The photometric technique employed to demonstrate the presence of ABO hemolysins is a modification of tH 50. A hemolysis time of less than 300 seconds was considered to be clinically significant. We detected ABO hemolysins in 57.89% of the sera of untreated children, with hemolysis times ranging between 100 and 210 seconds. None of the sera from the treated children presented ABO hemolysins. The results suggest that parasitic infection may be the external stimulus that provokes the appearance of ABO hemolysins. The photometric technique employed is simple and rapid, and is available to any routine laboratory