Advia 2120 Hematology Analyzer With Autoslide System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042251 FDA 510(k)
- FDA Product Code
- GKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5220 FDA 510(k)
- Regulation Number
- 864.5220 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advia 2120 Hematology Analyzer With Autoslide System is a Counter, Differential Cell device designed for automated hematology analysis. It performs quantitative measurements of complete blood cell counts, leukocyte differential counts, and reticulocyte analysis, enabling comprehensive blood parameter assessment in clinical settings.
This system operates in laboratory environments and includes an integrated slide stainer for reflexive slide preparation and staining based on predefined criteria. Supplied as a reusable medical device, it is intended for single-user or multi-user settings with appropriate maintenance protocols. The device holds an FDA 510(k) clearance under classification II, with registration number 1950302 and product code GKZ.
Frequently asked questions
What types of blood tests can the Bayer Advia 2120 Hematology Analyzer perform, and how does the Autoslide System enhance its functionality?
The Bayer Advia 2120 performs automated quantitative measurements for complete blood cell counts, leukocyte differential counts, and reticulocyte analysis. The integrated Autoslide System enhances functionality by automatically preparing and staining slides when predefined criteria are met, streamlining workflow for comprehensive blood parameter assessment in clinical settings.
Is the Bayer Advia 2120 designed for single-use or reusable applications, and what maintenance is required?
The Bayer Advia 2120 is a reusable medical device intended for use in either single-user or multi-user laboratory environments. It requires appropriate maintenance protocols to ensure accurate performance and longevity, though specific details would be outlined in the manufacturer’s operational guidelines.
What regulatory pathway was followed for FDA clearance of the Bayer Advia 2120, and what classification does it hold?
The Bayer Advia 2120 received FDA clearance through a 510(k) submission, classified as a Class II device under the regulatory pathway for Counter, Differential Cell devices. The clearance was granted under the Special 510(k) route, with a decision date of September 17, 2004.
How does the device’s design accommodate different laboratory workflows, particularly in terms of slide handling?
The device includes an integrated slide stainer within the Autoslide System, which automatically prepares and stains slides based on predefined criteria. This feature reduces manual intervention and supports reflexive workflows, making it adaptable for both high-volume and routine hematology testing environments.
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: Bayer Advia 2120 Hematology Analyzer With Autoslide System (K042251 ..., ADVIA® 2120i Autoslide Overview Video - Siemens Healthineers Academy, PDF SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® 2120 with Autoslid, ADVIA® 2120i Hematology System - Cardinal Health
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042251 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K042251 24 fields · synced Oct 6, 2026