(60 days)
CELL-DYN 4000 System, 510(k) #971152/S1
Not Found
No
The description focuses on standard hematology analysis methods (laser optical light scatter, impedance, absorption spectrophotometry) and does not mention any AI or ML techniques for data processing or classification.
No
The device is a hematology analyzer, used for classifying formed elements in blood for diagnostic purposes, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section states that the systems are "automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood," listing numerous blood cell parameters. The classification of these parameters in blood is a diagnostic function, as it provides information used to aid in the diagnosis of diseases or conditions.
No
The device description clearly outlines multiple hardware components including an Analyzer, Sample Loader, Data Station, and Color Printer, which are essential for the device's function of aspirating, diluting, and analyzing blood specimens.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is an "automated, multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anticoagulated blood". This means it analyzes blood samples in vitro (outside the body) to provide diagnostic information about the composition of the blood.
- Device Description: The description details how the device aspirates, dilutes, and analyzes whole blood specimens using methods like Laser Optical Light Scatter, Impedance, and Absorption Spectrophotometry. These are all techniques used to analyze biological samples in vitro.
- Sample Type: The device is designed to analyze "EDTA anticoagulated blood specimens", which are biological samples collected from a patient for in vitro analysis.
- Intended User / Care Setting: The intended user is "Laboratory use", which is a typical setting for performing in vitro diagnostic tests.
The core function of the device is to analyze biological samples (blood) outside the body to provide information about a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multiparameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood:
WBC -- White Blood Cell or Leukocyte Count
NEU -- Neutrophil Absolute Count
%N -- Neutrophil Percent
LYM -- Lymphocyte Absolute Count
%L -- Lymphocyte Percent
MONO -- Monocyte Absolute Count
%M -- Monocyte Percent
EOS -- Eosinophil Absolute Count
%E -- Eosinophil Percent
BASO -- Basophil Absolute Count
%B -- Basophil Percent
PLT -- Platelet Count
MPV -- Mean Platelet Volume
RBC -- Red Blood Cell or Erythrocyte Count
HCT - Hematocrit
MCV -- Mean Corpuscular Volume
RDW -- Red Cell Distribution Width
HGB -- Hemoglobin Concentration
MCH -- Mean Corpuscular Hemoglobin
MCHC -- Mean Corpuscular Hemoglobin Concentration
RETC -- Reticulocyte Concentration
% RETC -- Reticulocyte Concentration
IRF -- Immature Reticulocyte Fraction
*PDW -- Platelet Distribution Width
*PCT -- Plateletcrit
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The CELL-DYN 3500 and the CELL-DYN 3700 Systems have four main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen 2) the Sample Loader, which automatically identifies, mixes, and presents specimens for processing 3) the Data Station, which controls all system processing and provides the primary operator interface with the system and; 4) the Color Printer, which generates reports automatically or on demand. The analyzer counts, sizes and classifies blood cells by the combination of methods: Laser Optical Light Scatter, Impedance, and Absorption Spectrophotometry. The IRF is derived from the data measured for the Reticulocyte parameters. The CELL-DYN 3500 and the CELL-DYN 3700 Systems use 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. 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°) as each cell passes through the laser beam. The CELL-DYN 3500 and the CELL-DYN 3700 Systems report Reticulocyte % and Absolute Count. The IRF is a fraction of the total reticulocyte absolute count. The CELL-DYN 3500 and the CELL-DYN 3700 Systems are designed to analyze EDTA-anticoagulated whole blood specimens and report the additional Immature Reticulocyte Parameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data compiled to support the claim that the CELL-DYN 3500 and the CELL-DYN 3700 Systems IRF are substantially equivalent to the Abbott CELL-DYN 4000 System include background, accuracy, precision, linearity, and carryover. The data supports the claim that the CELL-DYN 3500 and the CELL-DYN 3700 Systems IRF parameters are substantially equivalent to the Abbott CELL-DYN 4000 System IRF parameter. The accuracy, precision, and linearity data shows performance to manufacturer's specifications. Data was collected at Scottsdale Health Care - Shea, Scottsdale, AZ; VAMC, Phoenix, AZ; and an internal Abbott Diagnostics Division site.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CELL-DYN 4000 System, 510(k) #971152/S1
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
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JUL - 9 1999
16. 510(k) Summary
CELL-DYN 3500 System and the CELL-DYN 3700 System with Immature Reticulocyte Fraction (IRF)
| Submitted by: | Abbott Laboratories
5440 Patrick Henry Drive
Santa Clara, CA 95054 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle B. Roeding
Phone: 408 567-3781
Fax:
408 982-4863 |
| Date Prepared: | May 7, 1999 |
| Proprietary Name: | CELL-DYN 3500 System with Immature
Reticulocyte Fraction (IRF)
CELL-DYN 3700 System with Immature
Reticulocyte Fraction (IRF) |
| Common Name: | Automated Hematology Analyzers |
| Classification Name: | Automated Differential Cell Counter (21 CFR 864.5220) |
| Predicate Device: | CELL-DYN 4000 System, 510(k) #971152/S1 |
K991605
510(k) Notification
1
16. 510(k) Summary (cont'd)
CELL-DYN 3500 System and the CELL-DYN 3700 System with Immature Reticulocyte Fraction (IRF)
Intended Use
The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood including:
| 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 Corpuscular Volume |
| LYM -- Lymphocyte Absolute Count | RDW -- Red Cell Distribution Width |
| %L -- Lymphocyte Percent | |
| MONO -- Monocyte Absolute Count | Hemoglobin Parameters: |
| %M -- Monocyte Percent | HGB -- Hemoglobin Concentration |
| EOS -- Eosinophil Absolute Count | MCH -- Mean Corpuscular Hemoglobin |
| %E -- Eosinophil Percent | MCHC -- Mean Corpuscular Hemoglobin |
| BASO -- Basophil Absolute Count | Concentration |
| %B -- Basophil Percent | |
| Platelet Parameters: | Reticulocyte Parameters: |
| PLT -- Platelet Count | RETC -- Reticulocyte Concentration |
| MPV -- Mean Platelet Volume | %R -- Reticulocyte Percent of RBC Count |
| *PDW -- Platelet Distribution Width | IRF -- Immature Reticulocyte Fraction |
| *PCT -- Plateletcrit |
- These parameters are provided for laboratory use only and are not reportable in the US.
Device Description:
The CELL-DYN 3500 and the CELL-DYN 3700 Systems have four main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen 2) the Sample Loader, which automatically identifies, mixes, and presents specimens for processing 3) the Data Station, which controls all system processing and provides the primary operator interface with the system and; 4) the Color Printer, which generates reports automatically or on demand.
2
16. 510(k) Summary (cont'd)
CELL-DYN 3500 System and the CELL-DYN 3700 System with Immature Reticulocyte Fraction (IRF)
Device Description (cont'd):
The analyzer counts, sizes and classifies blood cells by the combination of methods: Laser Optical Light Scatter, Impedance, and Absorption Spectrophotometry. The IRF is derived from the data measured for the Reticulocyte parameters. The CELL-DYN 3500 and the CELL-DYN 3700 Systems use 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.
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°) as each cell passes through the laser beam.
The CELL-DYN 3500 and the CELL-DYN 3700 Systems report Reticulocyte % and Absolute Count. The IRF is a fraction of the total reticulocyte absolute count. The CELL-DYN 3500 and the CELL-DYN 3700 Systems are designed to analyze EDTA-anticoagulated whole blood specimens and report the additional Immature Reticulocyte Parameter.
Similarities and Differences:
The CELL-DYN 3500 and the CELL-DYN 3700 Systems with IRF, and the CELL-DYN 4000 System are similar in that the systems use impedance for counting and sizing RBCs. The Reticulocyte Reagent enables both the CELL-DYN 3500 and the CELL-DYN 3700 Systems with IRF and the CELL-DYN 4000 System to count and classify mature and immature reticulocytes. The CELL-DYN 3500 and the CELL-DYN 3700 Systems with IRF and the CELL-DYN 4000 System with IRF, enumerate reticulocytes in EDTA-anticoagulated whole blood using optical laser scatter. They are different in that CELL-DYN 3500 and the CELL-DYN 3700 Systems with IRF specimens are externally stained in an off-line preparation step with New Methylene Blue while the CELL-DYN 4000 System with IRF automatically dilutes the specimen with a fast acting proprietary dye that requires no incubation prior to measurement.
3
16. 510(k) Summary (cont'd)
CELL-DYN 3500 System and the CELL-DYN 3700 System with Immature Reticulocyte Fraction (IRF)
Equivalency Data:
The data compiled to support the claim that the CELL-DYN 3500 and the CELL-DYN 3700 Systems IRF are substantially equivalent to the Abbott CELL-DYN 4000 System include background, accuracy, precision, linearity, and carryover. The data supports the claim that the CELL-DYN 3500 and the CELL-DYN 3700 Systems IRF parameters are substantially equivalent to the Abbott CELL-DYN 4000 System IRF parameter. The accuracy, precision, and linearity data shows performance to manufacturer's specifications. Data was collected at Scottsdale Health Care - Shea, Scottsdale, AZ; VAMC, Phoenix, AZ; and an internal Abbott Diagnostics Division site.
Conclusion:
The CELL-DYN 3500 and the CELL-DYN 3700 Systems IRF demonstrate substantial equivalence to the predicate device.
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17. Financial Disclosure
Data was collected from two field clinical sites and one internal site.
The two clinical sites were Scottsdale Health Care - Shea, Scottsdale, Arizona and Veteran's Affairs Medical Center (VAMC), Phoenix, Arizona. Scottsdale Health Care was paid $14,000 on 12/11/98, VAMC was paid $5,984.78 on 12/9/98. Neither site's reimbursement exceeded $25,000.00 for this clinical study.
The internal Abbott Diagnostics Division site in Santa Clara, CA also collected data for this clinical study. Financial disclosure is not applicable as there was no payment involved.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a flowing, wave-like design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 9 1999
Ms. Michelle B. Roeding Regulatory Affairs Supervisor Abbott Laboratories Diagnostic Division 5440 Patrick Henry Drive Santa Clara, California 95054
- K991605 Re:
Trade Name: CELL-DYN 3500 System with Immature Reticulocyte Fraction CELL-DYN 3700 System with Immature Reticulocyte Fraction Regulatory Class: III Product Code: GKZ Dated: May 7, 1999 Received: May 10, 1999
Dear Ms. Roeding:
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 (OS) 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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Page 2
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 (770) 488-7655.
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"(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 (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
7
Indications For Use Statement
K980614/A1 510(k): CELL-DYN 3500 System with Immature Reticulocyte Fraction Device Name: CELL-DYN 3700 System with Immature Reticulocyte Fraction
Indications for Use: The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multiparameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood:
| 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 Corpuscular Volume |
| LYM -- Lymphocyte Absolute Count | RDW -- Red Cell Distribution Width |
| %L -- Lymphocyte Percent | HGB -- Hemoglobin Concentration |
| MONO -- Monocyte Absolute Count | MCH -- Mean Corpuscular Hemoglobin |
| %M -- Monocyte Percent | MCHC -- Mean Corpuscular Hemoglobin |
| EOS -- Eosinophil Absolute Count | Concentration |
| %E -- Eosinophil Percent | RETC -- Reticulocyte Concentration |
| BASO -- Basophil Absolute Count | % RETC -- Reticulocyte Concentration |
| %B -- Basophil Percent | IRF -- Immature Reticulocyte Fraction |
| PLT -- Platelet Count | *PDW -- Platelet Distribution Width |
| MPV -- Mean Platelet Volume | *PCT -- Plateletcrit |
- These parameters are provided for laboratory use only and 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)
Alkem
(Division Sign-Off)/
Sign-on aboratory Devices Nag 1605
Clinical
(Division of Clinical 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use