CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE

{0}------------------------------------------------ KD12934 | 510(k)<br>Summary | CELL-DYN 3200 System with Absolute and Percent Reticulocyte | | |-------------------|-------------------------------------------------------------|--------------------------------------------------------------------------| | | Submitted by: | Abbott Laboratories<br>5440 Patrick Henry Drive<br>Santa Clara, CA 95054 | | | Contact Person: | John Dean<br>Phone: (408) 567-3430<br>Fax: (408) 567-3523 | | | Date Prepared: | August 30, 2001 | | | Proprietary Name | CELL-DYN 3200 System with Absolute and<br>Percent Reticulocyte | | | Common Name: | Automated Hematology Analyzer | | | Classification Name: | Automated Differential Cell Counter<br>(21 CRF 864.5220) | | | Predicate Device: | CELL-DYN 4000 System, K961439/S1 | #### Intended Use: The CELL-DYN 3200 System with Absolute and Percent Reticulocyte count is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories. ### Device Description: The CELL-DYN 3200 System has three main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; 2) the Data Module, which automatically analyzes, stores, and reports specimen results; 3) the Display Station, which consists of a color monitor and pressure-sensitive keypad for selecting the displayed commands that operate the system. The Analyzer and Data Module are housed in a single chassis. The Display Station is a stand-alone module. The analyzer counts, sizes and classifies blood cells by Optical Laser Light Scatter. The CELL-DYN 3200 System uses a Helium-Neon laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures. 10 {1}------------------------------------------------ For the reticulocyte parameters, an off-line dilution of blood and Reticulocyte Reagent is prepared and stained for 15 minutes. The dilution is aspirated and the reticulocytes are counted in the WOC channel. Data are collected for scatter (0, 10, and 90 degree) as each cell passes through the laser beam. The CELL-DYN 3200 System is designed to analyze EDTAanticoagulated whole blood specimens and report the additional Absolute and Percent Reticulocyte Parameters. The CELL-DYN 3200 System is designed to classify the following formed elements of EDTA-anticoagulated blood: | White blood Cell Parameters: | Red Blood Cell Parameters: | |-----------------------------------------------|------------------------------------------------| | WBC -- White Blood Cell or<br>Leukocyte Count | RBC -- Red Blood Cell or<br>Erythrocyte Count | | NEU -- Neutrophil Absolute<br>Count | HCT -- Hematocrit | | %N -- Neutrophil Percent | MCV -- Mean Cell Volume | | LYM -- Lymphocyte Absolute<br>Count | RDW -- Red Cell Distribution<br>Width | | %L -- Lymphocyte Percent | Hemoglobin Parameters: | | MONO -- Monocyte Absolute<br>Count | HGB -- Hemoglobin<br>Concentration | | %M -- Monocyte Percent | MCH -- Mean Cell Hemoglobin | | EOS -- Eosinophil Absolute Count | MCHC -- Mean Cell Hemoglobin<br>Concentration | | %E -- Eosinophil Percent | | | BASO -- Basophil Absolute Count | | | %B -- Basophil Percent | | | Platelet Parameters:<br>PLT -- Platelet Count | Reticulocyte Parameters: | | MPV -- Mean Platelet Volume | RETIC ABS-- Reticulocyte<br>Absolute | | *PDW -- Platelet Distribution<br>Width | RETIC% -- Reticulocyte<br>Percent of RBC Count | | *PCT -- Plateletcrit | | * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S. ** For Laboratory Use Only, therefore it is not reportable. {2}------------------------------------------------ ### Similarities and Differences: The CELL-DYN 3200 and the CELL-DYN 4000 System are similar in that both systems enumerate reticulocytes in EDTA-anticoagulated whole blood using New Methylene Blue N dye and optical laser scatter. The two Reticulocyte Reagents enable both the CELL-DYN 3200 and the CELL-DYN 4000 Systems to count and classify reticulocytes. Blood specimens for the CELL-DYN 3200 are externally stained in an off-line preparation step with New Methylene Blue N that requires incubation prior to measurement, while the CELL-DYN 4000 system automatically aliquots Reticulocyte Reagent containing the dye when CBC + RETC or CBC + RETC, Resistant RBC test is selected. They are different in that the Analyzer and Data Module of the CELL-DYN 3200 are housed in a single chassis while the CELL-DYN 4000 has a stand-alone data station consisting of a monitor, CPU and keyboard. ## Equivalency Data: The data compiled to support the claim that the CELL-DYN 3200 System with Reticulocyte Percent (RETIC %) and Reticulocyte Absolute (RETIC ABS) parameters is substantially equivalent to the CELL-DYN 4000 System includes: background, carryover, linearity, precision, and accuracy. The data supports the claim that the CELL-DYN 3200 System with RETIC % and RETIC ABS parameters is substantially equivalent to the CELL-DYN 4000 System. The background, carryover, linearity, precision, and accuracy data shows performance to manufacturer's specifications. Data was collected at an internal Abbott Diagnostics Division site. ### Conclusion: The CELL-DYN 3200 System with RETIC % and RETIC ABS parameters demonstrates substantial equivalence to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. John Dean Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054 Re: K012934 Trade/Device Name: CELL-DYN® 3200 System with Absolute and Percent Reticulocyte Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: August 30, 2001 Received: August 31, 2001 SEP 2 8 2001 Dear Mr. Dean: 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. {4}------------------------------------------------ ### Page 2 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {5}------------------------------------------------ # Indications for Use Statement K012934 5 10(k) Number (if known): Device Name: CELL-DYN® 3200 System with Absolute and Percent Reticulocyte Indications for Use: The CELL-DYN 3200® System with Absolute and Percent Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood: | White blood Cell Parameters: | Red Blood Cell Parameters: | |--------------------------------------------|---------------------------------------------| | WBC -- White Blood Cell or Leukocyte Count | RBC -- Red Blood Cell or Erythrocyte Count | | NEU -- Neutrophil Absolute Count | HCT -- Hematocrit | | %N -- Neutrophil Percent | MCV -- Mean Cell Volume | | LYM -- Lymphocyte Absolute Count | RDW -- Red Cell Distribution Width | | %L -- Lymphocyte Percent | Hemoglobin Parameters: | | MONO -- Monocyte Absolute Count | HGB -- Hemoglobin Concentration | | %M -- Monocyte Percent | MCH -- Mean Cell Hemoglobin | | EOS -- Eosinophil Absolute Count | MCHC -- Mean Cell Hemoglobin Concentration | | %E -- Eosinophil Percent | Reticulocyte Parameters: | | BASO -- Basophil Absolute Count | RETIC ABS -- Reticulocyte Absolute | | %B -- Basophil Percent | RETIC% -- Reticulocyte Percent of RBC Count | | Platelet Parameters: | | | PLT -- Platelet Count | | | MPV -- Mean Platelet Volume | | | *PDW -- Platelet Distribution Width | | | *PCT -- Plateletcrit | | * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use | |---------------------|-----------------------------------------| | (Division/Sign-Off) | | | | Division of Clinical Laboratory Devices | | 510(k) Number | K 010934 |