MODIFICATION OF: CELL-DYN 1200 SYSTEM

K992444 · Abbott Laboratories · GKZ · Sep 24, 1999 · Hematology

Device Facts

• Record ID: K992444
• Device Name: MODIFICATION OF: CELL-DYN 1200 SYSTEM
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The CELL-DYN® 1200 System is an automated multi-parameter hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physicians Office Laboratory (POL) to classify the following formed elements of EDTA anti-coagulated blood: White Blood Cell Parameters: WBC - White Blood Cell or leukocyte count GRAN -- Granulocyte absolute count %GRAN -- Granulocyte percent LYM - Lymphocyte absolute count %L - Lymphocyte percent MID – Mid-range absolute count %M - Mid-range percent Platelet Parameters: PLT - Platelet Count MPV - Mean Platelet Volume PDW* - Platelet Distribution Width CT* - Plateletcrit Red Blood Cell Parameters: RBC - Red Blood Cell or erythrocyte count HCT - Hematocrit MCV - Mean Corpuscular Volume RDW - Red Cell Distribution Width Hemoglobin Parameters: HGB - Hemoglobin Concentration MCH -- Mean Cell Hemoglobin MCHC -- Mean Cell Hemoglobin Concentration *Clinical significance has not been established for these parameters. Therefore, they are not reportable in the US.

Device Story

Automated multi-parameter hematology analyzer; processes EDTA anti-coagulated blood samples. Uses impedance and focused flow methods for cell counting/sizing; spectrophotometric method (540nm +/- 20nm) for hemoglobin concentration. Incorporates coincidence loss principle for cell counting. Operated by laboratory personnel in clinical labs, medical clinics, or POLs. System aspirates, dilutes, and mixes specimens; provides quantitative hematology parameters to clinicians. Output assists in hematological assessment and patient diagnosis.

Clinical Evidence

Bench testing only. Performance validated via correlation studies comparing CELL-DYN 1200 to CELL-DYN 1700. Metrics included background, carryover, accuracy, precision, linearity, and quality control. No clinical patient outcome data provided.

Technological Characteristics

Automated hematology analyzer; impedance and focused flow sensing; spectrophotometric hemoglobin measurement (540nm). Benchtop form factor. Analyzes EDTA anti-coagulated blood. No specific material standards or software architecture details provided.

Indications for Use

Indicated for in-vitro diagnostic classification of formed elements in EDTA anti-coagulated blood (WBC, RBC, Platelet, and Hemoglobin parameters) in clinical laboratories, medical clinics, and Physician's Office Laboratories (POL).

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

• CELL-DYN 1700 System

Submission Summary (Full Text)

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13. (cont'd)

# 510(k) SUMMARY CELL-DYN® 1200 System

#### Intended Use

The CELL-DYN® 1200 System is an automated multi-parameter hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physicians Office Laboratory (POL) to classify the following formed elements of EDTA anti-coagulated blood:

#### White Blood Cell Parameters:

WBC - White Blood Cell or leukocyte count GRAN -- Granulocyte absolute count %GRAN -- Granulocyte percent LYM - Lymphocyte absolute count %L - Lymphocyte percent MID – Mid-range absolute count %M - Mid-range percent Platelet Parameters: PLT - Platelet Count MPV - Mean Platelet Volume PDW* - Platelet Distribution Width CT* - Plateletcrit

# Red Blood Cell Parameters:

RBC - Red Blood Cell or erythrocyte count HCT - Hematocrit MCV - Mean Corpuscular Volume RDW - Red Cell Distribution Width Hemoglobin Parameters: HGB - Hemoglobin Concentration MCH -- Mean Cell Hemoglobin MCHC -- Mean Cell Hemoglobin Concentration

*Clinical significance has not been established for these parameters. Therefore, they are not reportable in the US.

# Principles of Operation

The CELL-DYN 1200 System counts, sizes, and classifies blood cells by impedance and focused flow methods, which incorporates electrical resistance and electronic sizing principles. Each specimen is aspirated, diluted and mixed before the hematology parameters are measured. The CELL-DYN 1200 System utilizes a spectrophotometric method for hemoglobin concentration, which is measured optically by absorbance at 540nm +20nm. The system incorporates the coincidence loss principle for each cell that is counted.

#### Similarities and Differences

The CELL-DYN 1200 System operating in the POL is the same as the CELL-DYN 1200 System operated in the Clinical Laboratory.

# Equivalency Data

The data compiled to support the claim that the CELL-DYN 1200 System is substantially equivalent when used either in a POL or in a Clinical Laboratory includes background, carryover, accuracy, precision,

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# 510(k) SUMMARY CELL-DYN® 1200 System

# Equivalency Data (cont'd)

linearity and quality control. Correlation equivalence is demonstrated between the CELL-DYN 1200 System and the CELL-DYN 1700 System for the following measured parameters: White Blood Count (WBC), WBC differential sub populations, Red Blood Count (RBC), Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Platelet Count (PLT), Mean Platelet Volume (MPV), and Red Cell Distribution Width (RDW).

# Conclusion

The modified device has demonstrated comparable performance characteristics to the predicate device when operated in the POL environment and supports the labeling change to include placement in POLS.

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# SEP 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janice E. Brown Regulatory Affairs Manager Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054

Re: K992444 Trade Name: CELL-DYN® 1200 System Regulatory Class: II Product Code: GKZ Dated: July 21, 1999

Received: July 22, 1999

#### Dear Ms. Brown:

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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Flectronic Product

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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 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 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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#### Indications for Use Statement 14.

10(k) Number (if known): k992444

Device Name:

CELL-DYN® 1200 System

#### Indications for Use:

The CELL-DYN 1200 System is an automated, multi-parameter hematology analyzer intended for invitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physician's Office Laboratory (POL) to classify the following formed elements of EDTA anti-coagulated blood:

| White Blood Cell Parameters: | Red Blood Cell Parameters: |
|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| WBC – White Blood Cell or leukocyte count | RBC – Red Blood Cell or erythrocyte count |
| GRAN - Granulocyte absolute count | HCT - Hematocrit |
| %GRAN - Granulocyte percent | MCV - Mean Corpuscular Volume |
| LYM – Lymphocyte absolute count | RDW – Red Cell Distribution Width |
| %L - Lymphocyte percent | Hemoglobin Parameters: |
| MID – Mid-range absolute count | HGB – Hemoglobin Concentration |
| %M - Mid-range percent | MCH – Mean Cell Hemoglobin |
| Platelet Parameters: | MCHC – Mean Cell Hemoglobin Concentration |
| PLT – Platelet Count | |
| MPV – Mean Platelet Volume | |
| *PDW – Platelet Distribution Width | |
| *PCT – Plateletcrit | |
| * Clinical significance has not been established for these parameters.<br>Therefore, they are not reportable in the US. | |

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Melin

OR

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