BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K982802 · Bayer Corp. · GKZ · Sep 22, 1998 · Hematology

Device Facts

• Record ID: K982802
• Device Name: BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: GKZ · Hematology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The ADVIA 60 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In Vitro diagnostic use in clinical laboratories.

Device Story

ADVIA 60 Hematology System; automated in vitro diagnostic analyzer for clinical laboratories. Inputs: whole blood samples. Principle: RBC/WBC/Plt counts via impedance variation through calibrated micro-aperture; hemoglobin via modified cyanmethemoglobin method; WBC differential via volumetric study of leukocytes post-dilution/lysis. Outputs: quantitative hematological parameters (18 total) printed via integrated module. Used by laboratory personnel to assist in hematological assessment; results support clinical decision-making regarding patient blood health.

Clinical Evidence

Bench testing only. Comparison of ADVIA 60 and ABX MICROS demonstrated equivalent accuracy, precision, linearity, and carryover for CBC and WBC differential parameters.

Technological Characteristics

Automated hematology analyzer; impedance-based cell counting; modified cyanmethemoglobin method for hemoglobin; volumetric leukocyte differential analysis; includes analytical module and printer; in vitro diagnostic use.

Indications for Use

Indicated for use in clinical laboratories as an automated in vitro diagnostic hematology analyzer to determine 18 hematological parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, and leukocyte differential counts (lymphocytes, monocytes, granulocytes).

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

• ABX MICROS Hematology System

Submission Summary (Full Text)

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#### SEP 2 2 1998 510(k) Summary of Safety and Effectiveness

information provides data supporting a substantially equivalent The following determination between the ADVIA 60 Hematology System and the ABX MICROS Hematology System for CBC and WBC differential parameters.

# Intended Use

The ADVIA 60 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In Vitro diagnostic use in clinical laboratories.

## Device Description

The ADVIA 60 Hematology System consists of an analytical module that aspirates, dilutes, and analyzes whole blood samples along with a printer that optionally generates reports based on the instrument results.

The ADVIA 60 Hematology System reports the following hematological parameters:

White Blood Cell Parameters WBC - white blood cell count GRA - granulocyte count (percentage and absolute counts) LYM - lymphocyte count (percentage and absolute counts) MON - mononuclear 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

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

Platelet Parameters Pit - platelet count MPV - mean platelet volume

### Principles of Operation

The principles of operation of the ADVIA 60 Hematology System are similar to those of the ABX MICROS Hematology System.

The RBC/WBC/Plt parameters are counted based on impedance variation generated by the passage of cells through a calibrated micro-aperture.

hemoglobin parameters are based on a modification of the The manual International Committee cyanmethemoglobin method developed by the for Standardization in Hematology.

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The WBC differential parameters are derived through a volumetric study of leukocytes after the use of a diluent and lysing reagent.

### Conclusion

The test results included in this submission demonstrate that the ADVIA 60 Hematology System and the ABX MICROS Hematology System have equivalent accuracy, precision, linearity, and carryover.

Gabriel J. Muraca, Jr.

7/31/98

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Date

Gabriel Manager Regulatory Aff Bayer Corporation 511Benedict Avenue Tarrytown, New York 10591-5097

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SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K982802 Trade Name: Bayer ADVIA® 60 Hematology System Regulatory Class: II Product Code: GKZ Dated: July 31, 1998 Received: Auqust 10, 1998

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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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.

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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 labelinq regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

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Page 1 of 1

510(k) Number (if known): K9826802

# Device Name: Bayer ADVIA® 60 Hematology System

Indications For Use:

The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) hematological parameters:

| white blood cells (leukocytes) | WBC |
|-------------------------------------------|------|
| red blood cells (erythrocytes) | RBC |
| hemoglobin | HGB |
| hematocrit | HCT |
| mean corpuscular volume | MCV |
| mean corpuscular hemoglobin | MCH |
| mean corpuscular hemoglobin concentration | MCHC |
| red blood cell distribution width | RDW |
| platelets | PLT |
| mean platelet volume | MPV |
| lymphocyte (number) | #LYM |
| lymphocyte (percent of WBC) | %LYM |
| monocyte (number) | #MON |
| monocyte (percent of WBC) | %MON |
| granulocyte (number) | #GRA |
| granulocyte (percent of WBC) | %GRA |

The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters:

- ·16 parameters
- · 8 parameters (WBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT)
- · 5 parameters (WBC, RBC, MPV, HGB, HCT)

Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------|------------------------------------------------------------------------------------------------------------|-------------------------|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | Optional Format 1-2-96) |
| | <div>(Division Sign-Off)</div> <div>Division of Clinical Laboratory Devices</div> <div>510(k) Number</div> | |