ABL555 Blood Gas, Electrolyte & Metabolite System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K974818 FDA 510(k)
- FDA Product Code
- MMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1215 FDA 510(k)
- Regulation Number
- 862.1215 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ABL555 Blood Gas, Electrolyte & Metabolite System is a standalone analyzer designed for measuring blood gas parameters, electrolytes, and metabolites. It quantifies pH, partial pressures of carbon dioxide (pCO₂) and oxygen (pO₂), sodium (Na⁺), potassium (K⁺), and glucose in whole blood samples. This device supports clinical assessment of acid-base balance, electrolyte status, and metabolic function, aiding diagnostic and treatment decisions in acute care and laboratory settings.
The system is intended for use in clinical chemistry environments and operates as a reusable, non-sterile instrument. It is classified as a Class II medical device under FDA regulations (862.1215) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Dimensions are 40 cm × 55 cm × 40 cm, with a weight of 37.5 kg. No MRI safety information or single-use specifications are provided in the regulatory data.
Frequently asked questions
What clinical parameters does the ABL555 measure in blood samples?
The ABL555 Blood Gas, Electrolyte & Metabolite System quantifies pH, partial pressures of carbon dioxide (pCO₂) and oxygen (pO₂), sodium (Na⁺), potassium (K⁺), and glucose levels in whole blood. These measurements support clinical evaluation of acid-base balance, electrolyte status, and metabolic function, aiding diagnostic and treatment decisions in acute care and laboratory environments.
Is the ABL555 analyzer reusable or single-use, and what is its sterility status?
The ABL555 is designed as a reusable instrument and is classified as non-sterile. Reusability is typical for standalone analyzers in clinical chemistry settings, where the core device itself is cleaned and maintained between uses, while consumables like test strips or cartridges may be single-use. Always follow manufacturer guidelines for cleaning and maintenance to ensure accuracy and safety.
What are the physical dimensions and weight of the ABL555?
The ABL555 has dimensions of 40 cm × 55 cm × 40 cm and weighs 37.5 kg. These specifications are important for laboratory space planning, ensuring adequate bench or countertop clearance and structural support for the device.
What regulatory clearance does the ABL555 hold, and how is it classified?
The ABL555 Blood Gas, Electrolyte & Metabolite System is classified as a Class II medical device under FDA regulations (862.1215) and has received FDA 510(k) clearance. This clearance indicates that the device is substantially equivalent to a predicate device already on the market, meeting the FDA’s requirements for safety and effectiveness in its intended clinical chemistry applications.
Can the ABL555 be used in environments where MRI compatibility is a concern?
The provided regulatory data does not include MRI safety information for the ABL555. If MRI compatibility is a requirement in your facility, verify with the manufacturer whether the device or its components contain metallic or ferromagnetic materials that could pose risks in an MRI environment.
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. Sources consulted: Abl555 Blood Gas, Electrolyte & Metabolite System, Abl555 Blood Gas, Electrolyte & Metabolite System (K974818) — Fda 510 ..., PDF K973367 - Abl555 Blood Gas, Electrolyte & Metabolite System, PDF K974818 - Abl555 Blood Gas, Electrolyte & Metabolite System, ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974818 | Class II | Active |
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Manufacturer
- Manufacturer
- Radiometer America, Inc.
Sources (1)
- FDA 510(k) K974818 24 fields · synced Oct 1, 2026