QS90 Smooth E Arterial Blood Sampler
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K896514 FDA 510(k)
- FDA Product Code
- GIM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QS90 Smooth E Arterial Blood Sampler is a vacuum sample tube with anticoagulant, classified under device class 2 and product code GIM. It is designed for the collection of arterial blood specimens for diagnostic testing.
This device is supplied as a single-use, sterile blood collection tube intended for use in acute care diagnostics settings. It has received FDA 510(k) clearance under regulation number 862.1675 and is manufactured by Radiometer America, Inc. for clinical chemistry applications.
Frequently asked questions
What is the QS90 Smooth E Arterial Blood Sampler used for?
The QS90 Smooth E Arterial Blood Sampler is designed for the collection of arterial blood specimens for diagnostic testing, specifically in acute care settings where clinical chemistry analysis is required.
How is the QS90 Smooth E Arterial Blood Sampler supplied and is it sterile?
The device is supplied as a single-use, sterile blood collection tube, ensuring it is free from microbial contamination and ready for immediate use in clinical environments without additional processing.
Can the QS90 Smooth E Arterial Blood Sampler be reused after initial use?
No, the QS90 Smooth E Arterial Blood Sampler is intended for single-use only; reuse is not recommended as it may compromise sample integrity, increase contamination risk, and violate the device’s design and labeling specifications.
What regulatory pathway was used for the QS90 Smooth E Arterial Blood Sampler?
The device received FDA 510(k) clearance, demonstrating it is substantially equivalent to a legally marketed predicate device under regulation number 862.1675 for vacuum sample tubes with anticoagulant.
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: QS90 SMOOTH E ARTERIAL BLOOD SAMPLER - fda.report, PDF K896514 - Qs90 Smooth E Arterial Blood Sampler, Acute care diagnostics solutions - Radiometer America, Radiometer America… — 50 FDA 510 (k)s · DeviceClearance, Contact Radiometer America
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896514 | Class II | Active |
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Manufacturer
- Manufacturer
- Radiometer America, Inc.
Sources (1)
- FDA 510(k) K896514 24 fields · synced Sep 26, 2026