ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM

K971998 · Bayer Corp. · GKL · Aug 29, 1997 · Hematology

Device Facts

• Record ID: K971998
• Device Name: ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
• Applicant: Bayer Corp.
• Product Code: GKL · Hematology
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.

Device Story

ADVIA 120 Hematology System is an automated analyzer for clinical laboratories; processes whole blood samples via analytical module and autosampler. System uses laser light scatter, light absorption (tungsten source), and refractive index to measure WBC, RBC, platelet, hemoglobin, and reticulocyte parameters. Peroxidase activity used for WBC differential; nucleic acid dye used for reticulocytes. Computer workstation manages instrument control, data processing, and user interface; printer generates reports. Healthcare providers use output for hematological assessment and clinical decision-making. Benefits include automated, accurate, and precise blood cell counting and characterization.

Clinical Evidence

Bench testing only. Comparison of ADVIA 120 Hematology System to Technicon H-3 RTC demonstrated equivalent accuracy, precision, linearity, and carryover for CBC, WBC differential, and reticulocyte parameters.

Technological Characteristics

Automated hematology analyzer; analytical module with autosampler; computer workstation; printer. Sensing principles: laser light scatter, light absorption (tungsten source), refractive index, and nucleic acid dye absorption. Hemoglobin measurement based on modified cyanmethemoglobin method. System is a standalone clinical laboratory instrument.

Indications for Use

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

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• Technicon H-3 RTC

Submission Summary (Full Text)

{0}------------------------------------------------

1-11998

510(k) Summary of Safety and Effectiveness

# 510(k) Summary of Safety and Effectiveness

The following information provides data supporting a substantially equivalent determination between the ADVIA 120 Hematology System and the Technicon H-3 RTC for the CBC, WBC differential, and reticulocyte parameters.

# Intended Use

The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.

# Device Description

The ADVIA 120 Hematology System consists of the following: An analytical module that aspirates, dilutes, and analyzes whole blood samples. An autosampler that automatically mixes, identifies, and presents samples for processing. A computer workstation that controls the instrument, provides the 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.

The ADVIA 120 Hematology System 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

)

{1}------------------------------------------------

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 ceils 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

### Principles of Operation

The principles of operation of the ADVIA 120 Hematology System are similar to those of the H-3 RTC.

The WBC 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.

The RBC and platelet parameters are derived through laser light scatter and refractive index.

hemoglobin parameters are based on a modification of the manual The cyanmethemoglobin method developed by the 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.

### Conclusion

The test results included in this submission demonstrate that the ADVIA 120 Hematology System and the H-3 RTC have equivalent accuracy, precision, linearity, and carryover.

Gabriel J. Muraca, Jr.

Gabriel J. Muraca. Manager Regulatory Affairs Bayer Corporation 511Benedict Avenue Tarrytown, New York 10591-5097

5/29/99
Date

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, rendered in black.

Food and Drug Ad ninistration 2098 Gaither Road Rockville MD 20850

AUG 2 9 1997

Gabriel J. Muraca, Jr. .Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591 5097

K971998 Re : ADIVA™ 120 Hematology System Regulatory Class: II Product Code: GKL, GKZ Dated: July 23, 1997 Received: July 28, 1997

Dear Mr. Muraca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

്രവാസ്ത്രവുമായ പ

510(k) Number (if known):_

ADVIA 120 Hematology System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer The ADVIA 120 Homatology Bystein is at and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.

# vrite below this line-continue on another page if

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|