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The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+, K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option.

The cobas b 123 POC system consists of a modular analyzer incorporating a Linux-based graphical user interface with a large color touch screen interfacing the analyzer electronic, sensor, fluidic and AutoQC modules. The user interface module contains the analyzer CPU and all required electronic interfaces for external communication, data storage and data transfer. A single electrochemical sensor system independent of the reagent delivery system that utilizes Roche thick film technology consolidates the following analytes: pCO2, pH, calcium, potassium and sodium (potentiometric measurement); pO2 (amperometric measurement); Hct (conductivity measurement); Glucose and Lactate enzyme reaction (amperometric measurement). An optionally integrated oximeter module consisting of a spectrometer, measurement and calibration light source, respectively, an ultrasonic hemolyzer and thermostatic components measure SO2, tHb, O2Hb, HHb, COHb, and MetHb. A disposable, self-contained sample and reagent delivery system contains: Liquid reagents, calibrators and waste container, stable for 42 days on-board; Built-in safety shielded sample port; Built-in oximeter cuvette; Two peristaltic pump fluidics system; Built-in air filter. The system also includes an optional integrated AutoQC module which utilizes a disposable cassette containing three levels of quality control material. A smart memory chip is incorporated into each biosensor, reagent pack (sample and reagent delivery system) and AutoQC cassette providing the lot number, expiration date and value assignments (for QC and CVC materials). The chip also tracks and monitors sensor, reagent pack, AutoQC and AutoCVC cassette usage.

This is a 510(k) Summary for a medical device and therefore does not contain details about acceptance criteria, study methodologies, or performance against specific metrics as these are typically found in the full 510(k) submission. Acceptance criteria and detailed study information are usually proprietary data submitted to the FDA and are not part of the publicly available 510(k) Summary.

This document focuses on establishing substantial equivalence by comparing the cobas b 123 POC System and its associated control packs to previously cleared predicate devices. It lists the intended use, device descriptions, and similarities and differences between the new device and the predicate devices for various analytes.

Therefore, the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, training set sample size, and ground truth establishment) cannot be extracted from the provided text.

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