BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

K042251 · Bayer Healthcare, LLC · GKZ · Sep 17, 2004 · Hematology

Device Facts

• Record ID: K042251
• Device Name: BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
• Applicant: Bayer Healthcare, LLC
• Product Code: GKZ · Hematology
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The Bayer ADVIA 2120 Hematology System with Autoslide is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories. In addition, the system provides the added capability to automatically prepare and stain high-quality blood smears on a microscope slide.

Device Story

Modification to ADVIA 120 hematology analyzer; addition of integrated slide maker/stainer. Device detects abnormal samples; automatically reflexes to create slide for visual examination. Used in clinical laboratory settings by trained personnel. Output is prepared slide for microscopic review. Modification maintains fundamental scientific technology of original analyzer.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Integrated slide maker/stainer module added to ADVIA 120 hematology analyzer. System utilizes automated reflex logic based on sample abnormality detection. No changes to fundamental scientific technology.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for quantitative automated hematology analysis, including leukocyte differential counts, reticulocyte analysis, and automated blood smear preparation and staining.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• Bayer ADVIA 120 Hematology Analyzer (K971998)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K042251

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the purpose of adding a slide maker/stainer integrated to the original ADVIA 120 hematology analyzer so that when the analyzer detects an abnormal sample it can reflex the device to make a slide of that sample for visual examination.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, technology, and reagents.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments

(Reviewer's Signature)

(Date)

revised:3/27/98