ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD

K022331 · Bayer Diagnostics Corp. · GKL · Sep 11, 2002 · Hematology

Device Facts

• Record ID: K022331
• Device Name: ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
• Applicant: Bayer Diagnostics Corp.
• Product Code: GKL · Hematology
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

Device Story

The ADVIA 120 CSF method is an in vitro diagnostic system for analyzing CSF specimens. The process involves manual dilution of the CSF sample with a reformulated reagent that spheres and fixes cells; after a 4-minute incubation, the sample is aspirated into the ADVIA 120 Hematology System. The system uses laser optics to detect and enumerate cells based on light scatter and absorbance measurements. The device displays a scatter versus scatter versus absorbance cytogram and automatically calculates thresholds and results. It provides WBC, RBC, and WBC differential counts (Neut, Lymph, Mono, Eos, MN, PMN). The device is used in a laboratory setting by trained personnel. The output assists clinicians in evaluating CSF cell counts for diagnostic purposes.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and performance validation of the revised reagent and software against the predicate method.

Technological Characteristics

The device utilizes laser optics for light scatter and absorbance measurements. It employs a reformulated reagent for isovolumetric cell sphering and fixation. The system operates via manual open tube mode. Software includes a specific key to enable CSF mode. It is an accessory/method update to the existing ADVIA 120 Hematology System.

Indications for Use

Indicated for in vitro diagnostic, quantitative determination of blood cells (WBC, RBC, and WBC differential) in cerebrospinal fluid (CSF) specimens. Intended for laboratory use.

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

• ADVIA 120 CSF method (K003796)

Submission Summary (Full Text)

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# SEP 1 1 2002

# 510(k) Summary of Safety and Effectiveness

The following information provides data supporting a substantially equivalent determination between the revised ADVIA 120 cerebrospinal fluid (CSF) method and the current ADVIA 120 CSF method (K003796).

## Intended Use

The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

## Device Description

The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System.

- 1. A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
- 2. Revised software to calculate the cell counts.
- 3. A software key to selectively allow access to the CSF mode of the system software.
- 4. Control products to maintain quality control of the CSF method.

The following parameters are reported with the ADVIA 120 CSF method:

# 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)

# Principles of Operation

The CSF sample is mixed by manual dilution with ADVIA 120 CSF Reagent which isovolumetrically spheres and fixes the cells. After a 4-minute incubation period, the prepared sample is then aspirated directly into the ADVIA 120 system. The cells are then detected and enumerated based on light scatter and absorbance measurements using the ADVIA 120 laser optics. A scatter versus scatter versus absorbance cytogram is displayed with the thresholds and results automatically calculated for each sample

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# Similarities and Differences between the revised ADVIA 120 CSF Method and the ADVIA 120 CSF Predicate Method (K003796)

The following table provides similarities and differences between the revised ADVIA 120 CSF method and the predicate method.

| Similarities/Differences | Characteristic | Predicate<br>Method | Revised<br>Method |
|--------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | Intended Use | To provide a<br>quantitative<br>determination of blood<br>cells in CSF<br>specimens. | Same as predicate<br>method. |
| | Specimen<br>Analyzed | CSF collected in a<br>sterile specimen tube. | Same as predicate<br>method. |
| Differences | WBC Count | Automated dilution with<br>cell count performed in<br>the basophil channel of<br>the ADVIA 120. RBCs<br>are lysed in the<br>reaction. | Manual dilution<br>with cell counts<br>performed using<br>RBC optics. RBCs<br>are not lysed. |
| | RBC Count | Automated dilution with<br>cell count performed in<br>RBC/PIt channel of the<br>ADVIA 120. | Manual dilution<br>with cell counts<br>performed using<br>RBC optics. |
| | WBC Differential | Automated dilution with<br>cell count performed in<br>the peroxidase channel<br>of the ADVIA 120.<br>RBCs are lysed and<br>WBCs are<br>differentiated based on<br>morphology and<br>peroxidase activity. | Manual dilution<br>with cell performed<br>using RBC optics.<br>RBCs are not<br>lysed, and WBCs<br>are differentiated<br>based on<br>morphology only. |

# Conclusion

The test results included in this submission demonstrate that the revised ADVIA 120 CSF method meets the manufacturer's intended specifications and is substantially equivalent to the predicate device.

Kluwe E.D. Cole

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

Date

7/16/02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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od and Drug Administ 98 Gaither Road ockville MD 20850

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

k022331 Re:

> Trade/Device Name: Cerebrospinal Fluid Method for the Advia 120 Hematology Analyzer Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated cell counter Regulatory Class: II Product Code: GKL, GKZ, JPK Dated: August 28, 2002 Received: August 29, 2002

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 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 labeling 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Putman

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

#### 11022331 510(k) Number:

Device Name: Cerebrospinal Fluid Method for the Advia 120 Hematology Analyzer

Indications for Use: The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K022331 |

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

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