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Biostator GCIIS Blood Glucose Controller

FDA PMA

Class III (US FDA PMA)

PMA P790028

by Bayer Healthcare

Identity

Trade Name
BIOSTATOR GCIIS FDA PMA
Generic Name
Controller, closed-loop blood glucose FDA PMA

Identifiers

PMA Number
P790028 FDA PMA
FDA Product Code
LHE FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General Hospital FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S002 FDA PMA

The Biostator GCIIS is a Controller, Closed-Loop Blood Glucose (per FDA nomenclature), designed to automate the continuous monitoring and regulation of blood glucose levels in clinical settings. It employs a closed-loop system to maintain precise glucose control through real-time feedback, integrating infusion and monitoring functions for intensive care environments.

This device is intended for use in General Hospital settings and operates as a reusable, non-sterile medical instrument. Supplied with a product code of LHE, it requires proper calibration and maintenance per manufacturer instructions. Authorized under FDA_PMA (P790028), it adheres to strict regulatory standards for Class III devices, ensuring compliance with clinical safety protocols for glucose management.

Frequently asked questions

What clinical setting is the Biostator GCIIS designed for, and how does it differ from standard glucose monitoring devices?

The Biostator GCIIS is specifically designed for **general hospital intensive care environments**, where precise, automated blood glucose control is critical. Unlike standard glucose monitoring devices that provide intermittent readings, this device operates as a **closed-loop system**, continuously monitoring glucose levels and regulating insulin infusion in real time. This makes it ideal for patients requiring intensive glucose management, such as those in critical care, where manual adjustments would be impractical or insufficient.

Is the Biostator GCIIS intended for single-use or reusable applications, and what maintenance does it require?

The Biostator GCIIS is **not single-use**—it is classified as a reusable, non-sterile medical instrument. Like all reusable devices, it requires **regular calibration, cleaning, and maintenance** as outlined in the manufacturer’s instructions to ensure accurate glucose readings and reliable operation. Proper upkeep is essential for maintaining its performance in clinical settings.

How was the Biostator GCIIS approved by the FDA, and what does this mean for its use in hospitals?

The Biostator GCIIS was approved via an **FDA Premarket Approval (PMA) application (P790028)**, which is the highest regulatory standard for Class III medical devices. This approval indicates that the FDA has reviewed its safety and effectiveness for **automated, closed-loop blood glucose control in hospital settings**, ensuring it meets stringent clinical safety requirements before use. Hospitals can rely on this approval when integrating the device into their intensive care protocols.

What product code (LHE) signifies about the Biostator GCIIS, and how does it relate to its regulatory classification?

The product code **LHE** categorizes the Biostator GCIIS under the FDA’s classification system for **infusion pumps and blood glucose monitoring devices**. This code aligns with its role as a **closed-loop glucose controller**, which combines monitoring and infusion functions. Since it falls under **Class III** (as noted in the openFDA data), it requires rigorous pre-market approval (PMA) to ensure its safety and efficacy in managing critical glucose levels in hospitalized patients.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bayer Healthcare

Sources (1)

  • FDA PMA P790028 24 fields · synced Oct 6, 2026