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

Intended 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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## SEP 1 7 2004

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® 2120 with Autoslide

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

Ko4225 The assigned 510(k) number is: _

## 1. Intended Use

The Bayer ADVIA 2120 with Autoslide is a quantitative, automated hematology analyzer that The Dayer In 11 11 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 provides a leaded to the system provides the added capability to automatically prepare and stain high-quality blood smears on a microscope slide.

## 2. Predicate Device

Proprietary Name: Bayer ADVIA 120 Hematology Analyzer Common name: Automated Hematology Analyzer Classification name: Automated hematology complete blood cell counter (§ 864.5200), differential cell counter (§ 864.5220) Classification number: 21 CFR Parts 864.5200, 864.5220, Class II 510(k) Number: K971998

## 3. Device Information

Proprietary Name: Bayer ADVIA 2120 Hematology Analyzer with Autoslide System Common name: Automated Hematology Analyzer and Automated Maker and Stainer Comment in the name: Automated hematology complete blood cell counter (§ 864.5200), differential cell counter (§ 864.5220) and automated slide stainer (§ 864.3800) Classification number: 21 CFR Parts 864.5200, 864.5220, 864.3800 , Class II

## 4. Device Description

The ADVIA 2120 Hematology system with Autoslide is an integrated option of a Hematology analyzer with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.

The ADVIA 2120 Hematology system with Autoslide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an autosampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides primary user interface with the instrument and manages the data produced by the instrument; a printer that optionally generates reports based on the instrument results and an autoslide module that prepares a wedge smear from a drop of blood,

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places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grunwald Giemsa Staining techniques.

The ADVIA 2120 with Autoslide reports the following hematological parameters:

#### White Blood Cell Parameters

WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) Eos- eosinophil count (percentage and absolute counts) Baso- basophil count (percentage and absolute counts) LUC- large unstained cell count (percentage and absolute counts)

Red Blood Cell Parameters RBC- red blood cell count Hct- hematocrit MCV- mean corpuscular volume RDW- red cell volume distribution width CHCM- hemoglobin concentration mean HDW- hemoglobin concentration distribution width

Hemoglobin Parameters Hgb- hemoglobin concentration MCH- mean corpuscular hemoglobin MCHC- mean corpuscular hemoglobin concentration

Platelet Parameters Plt- platelet count MPV- mean platelet volume

#### Reticulocyte Count

Retic- reticulocyte count (percentage and absolute counts) MCVg- mean corpuscular volume of all gated red cells MCVr- mean corpuscular volume of reticulocytes CHCMg- hemoglobin concentration mean of all gated red cells CHCMr- hemoglobin concentration mean of reticulocytes CHg- mean hemoglobin content of all gated red cells CHr- mean hemoglobin content of reticulocytes

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In addition the ADVIA 2120 with Autoslide reports the following parameters with Cerebrospinal Fluid samples using the CSF method cleared for use on the ADVIA 120 under K022331:

### White Blood Cell Parameters

WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) Eos*- eosinophil count (percentage and absolute counts) MN- mononuclear count (percentage and absolute counts) PMN- polymorphonuclear count (percentage and absolute counts)

Red Blood Cell Parameters RBC- red blood cell count

* For Laboratory Use Only (not reportable)

The ADVIA 2120 with Autoslide supports the following staining techniques:

Wright Stain Wright-Giemsa Stain May-Grunwald Stain

## 5. Summary of Technological Characteristics

The principles of operation of the ADVIA 2120 Hematology System with Autoslide are similar to those of the ADVIA 120, the only difference is the ability of the ADVIA 2120 Hematology System with Autoslide to prepare a wedge smear from a drop of blood, place it on a microscope slide and stain the slide in accordance with Wright, Wright-Giemsa and May-Grunwald Giemsa Staining techniques.

The Autoslide module will dispense a drop of blood from the sample on a slide, the smearing assembly will create a smear using the surface tension of the blood. After smearing, the slide is sent to the printer where information on patient demographics can be printed along with any other necessary information. If staining is required, the slide moves into the stainer, where the slide is stained according to the staining method in use. Once staining is complete, the slide is transferred to a rack and processing is complete.

The hematological parameters supported by the ADVIA 2120 with Autoslide are the same and use the same technology as the predicate device, the ADVIA 120, below is a summary of the technological characteristics for each parameter:

The White Blood Cell parameters are derived through a combination of laser light scatter, as well as light scatter and absorption from a tungsten light source based on cellular peroxidase activity.

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The Red Blood Cell and Platelet parameters are derived through laser light scatter and refractive index.

The Hemoglobin parameters are based on a modification of the manual cyanmethemoglobin The Homogroum parantee International Committee for Standardization in Hematology.

The Reticulocyte parameters are derived through a combination of laser light scatter and absorption of a nucleic acid dye.

#### 6. Conclusion

Based on all the information provided as part of this submission the ADVIA 2120 Hematology system with Autoslide is substantially equivalent to the ADVIA 120 Hematology System.

Andrea Holle

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

8/17/04
Date

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a stylized eagle emblem. The eagle is depicted with three swooping lines forming its body and wings, symbolizing health and human services. The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, New York 10591

SEP 1 7 2004

k042251 Re: Trade/Device Name: ADVIA® 2120 with Autoslide Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ, KPA Dated: August 18, 2004 Received: August 20, 2004

Dear Mr. Holle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or you desire specific missition and advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may oounly other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., PhA Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): \$(14)255

Device Name: ADVIA® 2120 with Autoslide

Indications For Use:

The Bayer ADVIA 2120 Hematology System with Autoslide is a quantitative, The Bayer ADVIA 2120 Homatology Oyotin's a leukocyte differential count and automated nematology analyzof that promostic use in clinical laboratories. In addition, and stain high reticulocyce analysis for in vitro diagnounce as a stain highquality blood smears on a microscope slide.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Jacqueline Bautista
Division Sign-Off

Page 1 of 1__

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042251