ADVIA 60 HEMATOLOGY ANALYZER

K032524 · Bayer Healthcare, LLC · GKZ · Sep 8, 2003 · Hematology

Device Facts

• Record ID: K032524
• Device Name: ADVIA 60 HEMATOLOGY ANALYZER
• Applicant: Bayer Healthcare, LLC
• Product Code: GKZ · Hematology
• Decision Date: Sep 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.

Device Story

Hematology analyzer modification; software update to improve measurement linearity for WBC, RBC, HGB, HCT, and PLT parameters. Device processes blood samples to provide quantitative hematological measurements. Used in clinical laboratory settings by trained personnel. Output used by clinicians for diagnostic assessment of blood cell counts. Modification expands linearity ranges: WBC (0-100), RBC (0-8.0), HGB (0-26), HCT (0-80), PLT (0-2200/4000).

Clinical Evidence

Bench testing only; verification and validation activities performed per design controls to confirm performance against expanded linearity specifications for WBC, RBC, HGB, HCT, and PLT parameters.

Technological Characteristics

Hematology analyzer; software-based measurement processing; expanded linearity ranges for blood parameters. No changes to fundamental scientific technology.

Indications for Use

Indicated for in-vitro diagnostic quantitative determination of blood cells and hematologic parameters in whole blood specimens.

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.”

Submission Summary (Full Text)

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K032524

ADVIA 60 Software Version 1.6

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 60 with software version 1.6 and the predicate device, ADVIA 60 with software version 1.4.

The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the predicate device cleared to market under K982802.

The Abbott Cell-Dyn 4000 (K961439) is also used as a predicate device to establish clinical accuracy of the ADVIA 60 with software version 1.6.

### Intended Use

For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.

## Device Description

The ADVIA 60 with software version 1.6 is a bench top, clinical laboratory instrument that analyzes in-vitro samples of whole blood specimens. The device reports a complete blood count (CBC) and 3-part WBC differential (LMG). The device operates as either a closed tube/closed system or open tube/open system. The ADVIA 60 can evaluate 5, 8, 16, or 18 hematology parameters depending on its internal configuration.

## Principles of Operation

The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the ADVIA 60 with software version 1.4.

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

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

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

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Similarities and Differences between the ADVIA 60 with software version 1.6 and ADVIA 60 with software version 1.4 (predicate device K982802)

The following table provides similarities and differences between ADVIA 60 with software version 1.6 and ADVIA 60 with software version 1.4.

| Similarities/Differences | Characteristic | ADVIA 60 with Software<br>Version 1.4 | ADVIA 60 with Software<br>Version 1.6 |
|--------------------------|----------------|----------------------------------------------------|---------------------------------------|
| Similarities | Intended Use | Hematology analyzer for<br>in-vitro diagnostic use | Same as predicate device. |
| | Accuracy | As specified in product<br>labeling. | Equivalent to predicate<br>device. |
| | Precision | As specified in product<br>labeling. | Equivalent to predicate<br>device. |
| Difference | Linearity | As specified in product<br>labeling. | Expanded linearity claims |

## Similarities and Differences between the ADVIA 60 with software version 1.6 and Abbott Cell-Dyn 4000 (predicate device K961439)

The following table provides similarities and differences in the principles of measurement between ADVIA 60 with software version 1.6 and Abbott Cell-Dyn 4000.

| Similarities/Differences | Characteristic | Cell-Dyn 4000 | ADVIA 60 with Software<br>Version 1.6 |
|--------------------------|------------------|------------------------------------------------------|---------------------------------------|
| Similarities | RBC/Plt count | Aperture impedance | Aperture impedance |
| | Hgb measurement | Spectrophotometer | Spectrophotometer |
| Differences | WBC Count | Light scattering | Aperture impedance |
| | MCV | Light scattering | Calculated from Hct |
| | WBC Differential | Multiple angle polarized<br>light scatter separation | Aperture impedance |

## Conclusion

The test results included in this submission demonstrate that the ADVIA 60 with software version 1.6 has equivalent accuracy and precision to the ADVIA 60 with software version 1.4. Expanded linearity claims with version 1.6 are supported with the results included in this submission.

Amees B. Taka

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Date August 1, 2003

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP - 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Baver HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

k032524 Re:

> Trade/Device Name: ADVIA 60 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 1, 2003 Received: August 15, 2003

Dear Dr. Edds:

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 vour 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).

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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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page _1_ of _1_

510(k) Number: K032524

Device Name: ADVIA 60 hematology analyzer

Indications for Use:

For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use (Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032524