Gem Premier Plus Model 5500
by Mallinckrodt Sensor Systems, Inc.
510(k) K961335
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961335 | Date28 Jun 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Gem Premier Plus Model 5500 is an Electrode Measurement Device for Blood-Gases (PCO₂, PO₂) and Blood pH, designed to measure arterial and venous blood parameters. It employs electrochemical sensors to provide rapid, accurate analysis of oxygen tension, carbon dioxide tension, and pH levels in whole blood samples, supporting clinical decision-making in critical care settings.
This device is intended for use in clinical chemistry laboratories and point-of-care environments by healthcare professionals. Supplied as a reusable instrument with disposable sensor cartridges, it requires no specific sterility beyond standard laboratory hygiene protocols. The Model 5500 operates within Class II regulatory classification under FDA 510(k) clearance (K961335) and adheres to the regulatory requirements outlined in 21 CFR 862.1120. No MRI safety information or size variations are specified in the available data.
Other devices from Mallinckrodt Sensor Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Gem Premier Plus Model 5500 intended for use in, and why does it matter for my workflow?
The Gem Premier Plus Model 5500 is designed for use in clinical chemistry laboratories and point-of-care environments, such as intensive care units, emergency departments, or operating rooms where rapid blood-gas and pH analysis is critical. This matters for your workflow because it provides real-time measurements of arterial and venous blood parameters (PCO₂, PO₂, and pH), enabling faster clinical decision-making in critical care settings. The device’s electrochemical sensors ensure accuracy and speed, which are essential for monitoring patients with respiratory or metabolic disturbances.
Is the Gem Premier Plus Model 5500 a single-use or reusable device, and how does this affect maintenance?
The Gem Premier Plus Model 5500 is a reusable instrument, but it uses disposable sensor cartridges for each measurement. This design reduces maintenance burdens compared to fully disposable devices, as the core analyzer can be cleaned and recalibrated between uses. However, the disposable cartridges ensure consistency and minimize cross-contamination risks, requiring only standard laboratory hygiene protocols—no additional sterility measures are specified.
What regulatory pathway was followed for the Gem Premier Plus Model 5500, and how does this impact its use in my facility?
The Gem Premier Plus Model 5500 was cleared through the FDA’s 510(k) process (K961335), specifically under the Clinical Chemistry advisory committee (CH) and classified as a Class II device (21 CFR 862.1120). This means it was determined to be substantially equivalent to a predicate device already on the market, ensuring it meets established safety and performance standards. For your facility, this clearance indicates it’s been reviewed for clinical chemistry applications, but always verify compliance with your institution’s procurement and regulatory policies.
Does the Gem Premier Plus Model 5500 require special handling or storage conditions, and what should I consider before ordering?
The device does not specify unique storage conditions beyond standard laboratory practices, such as protecting it from extreme temperatures or physical damage. Since it’s a reusable analyzer with disposable cartridges, ensure your facility has a dedicated space for calibration, cleaning, and maintenance of the instrument. Additionally, confirm compatibility with your existing workflow for sensor cartridge supply chain management, as these are consumables that must be replenished regularly for continuous operation.