(26 days)
Not Found
No
The summary describes a standard automated hematology analyzer using established technologies like laser flow cytometry. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic hematology analyzer used for analyzing blood samples, not for directly treating a patient.
Yes
The "Intended Use / Indications for Use" section states that "The CELL-DYN Ruby System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories." Also, it aims to "report the following hematological parameters" which are used for diagnosis.
No
The device description explicitly states it is a "tabletop analyzer consisting of the main analyzer, data module, flat panel display station, and printer," and mentions hardware components like a "Sample Loader" and "laser flow cytometry." This indicates it is a physical hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The CELL-DYN Ruby System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories."
N/A
Intended Use / Indications for Use
The CELL-DYN Ruby System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories.
The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters:
White Blood Cell Parameters:
WBC - White Blood Cell Concentration
NEU - Neutrophil Absolute Concentration
%N - Neutrophil Percentage of WBC
LYM - Lymphocyte Absolute Concentration
%L - Lymphocyte Percentage of WBC
MONO - Monocyte Absolute Concentration
%M - Monocyte Percentage of WBC
EOS - Eosinophil Absolute Concentration
%E - Eosinophil Percentage of WBC
BASO - Basophil Absolute Concentration
%B - Basophil Percentage of WBC
Red Blood Cell Parameters:
RBC - Red Blood Cell Concentration
HCT - Hematocrit
MCV - Mean Cell Volume
RDW - Red Cell Distribution Width
%R - Reticulocyte Percent
RETC - Reticulocyte Absolute Concentration
Hemoglobin Parameters:
HGB - Hemoglobin Concentration
MCH - Mean Cell Hemoglobin
MCHC - Mean Cell Hemoglobin Concentration
Platelet Parameters:
PLT - Platelet Concentration
MPV - Mean Platelet Volume
Product codes
GKZ
Device Description
The CELL-DYN Ruby System is a tabletop analyzer consisting of the main analyzer, data module, flat panel display station, and printer. The main analyzer and data module are housed in a single chassis. The display station and printer are stand-alone modules. The CELL-DYN Ruby is equipped with a Sample Loader that provides continuous automated closed sampling for up to 50 closed tube samples at a time. The instrument's utilizes the CELL-DYN MAPSST™ technology, laser flow cytometry and a Microsoft® Windows® Operating System, USB connectivity on the data module to allow the interface of a wide variety of printer types and a standard hand-held bar code reader to help expedite patient specimen identification.
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
Clinical laboratories and physician office laboratories.
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)
Data on file at Abbott Laboratories consisting of background, carryover, imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity information shows performance to the manufacturer's specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity and specificity information shows performance to the manufacturer's specifications.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
JUL 10 2006
K061667
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of Safe
Medical Devices Act 1990 and 21 CFR 807.92. | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | CELL-DYN Ruby™ System | |
| Submitted by: | Abbott Laboratories
5440 Patrick Henry Drive
Santa Clara, CA 95054 | |
| Contact Person: | Michelle Roeding
Phone: (408) 567-3781
Fax: (408) 982-4863 | |
| Date Prepared: | June 13, 2006 | |
| Proprietary Name | CELL-DYN Ruby™ System | |
| Common Name: | Automated Hematology Analyzer | |
| Classification Name: | Automated Differential Cell Counter
(21 CRF 864.5220) | |
| Predicate Device: | CELL-DYN® 3200 System | |
| | K972354 – September 16, 1997
K980614 – April 24, 1998
K012934 – September 28, 2001 | |
| Intended Use: | The CELL-DYN Ruby System is a multiparameter, automated
hematology analyzer designed for in vitro diagnostic use in
clinical laboratories and physician office laboratories. | |
| Device Description: | The CELL-DYN Ruby System is a tabletop analyzer consisting
of the main analyzer, data module, flat panel display station, and
printer. The main analyzer and data module are housed in a
single chassis. The display station and printer are stand-alone
modules. The CELL-DYN Ruby is equipped with a Sample
Loader that provides continuous automated closed sampling for
up to 50 closed tube samples at a time.
The instrument's utilizes the CELL-DYN MAPSST™ technology,
laser flow cytometry and a Microsoft® Windows® Operating
System, USB connectivity on the data module to allow the
interface of a wide variety of printer types and a standard | |
..
1
hand-held bar code reader to help expedite patient specimen identification.
The CELL-DYN 3200 and the CELL-DYN Ruby System are similar in that:
- Both systems consist of an Analyzer and Data Module a. housed in a single chassis with a standalone display.
- b. Both systems provide quantitation of the hemogram and automated WBC differential parameters in EDTAanticoagulated human whole blood specimens.
- Both systems will accept specimens presented C. automatically by the autoloader or manually presented by the operator.
- d. Both systems utilize laser optical scatter (WBC, RBC and PLT) and optical absorbance methods (HGB) using a Helium Neon laser.
- e. Both systems utilize a single step offline staining procedure for reticulocyte analysis.
- f. Both systems provide Dispersional Data Alerts, Suspect Parameter Messages, and Suspect Population Flags to assist in data review.
- Both systems accept input from the keyboard and send g. data output to: video screen, hard drive, and printer; and both systems provide RS232 Interface to an on-line LIS as well as using microprocessors for systems control, data acquisition, and data analysis.
- h. Both systems utilize the same reagent formulations.
- i. Both systems have Moving Average Programs (X-B) for WBC, RBC parameters and the capability to download QC to media for online peer QC review.
- Both systems are able to search patient demographics. i.
The CELL-DYN Ruby System and the CELL-DYN 3200 System are different in that:
Similarities and Differences:
2
- The CELL-DYN Ruby uses a Microsoft® Windows® a. XP operating system, while the CELL-DYN 3200 uses Microsoft® DOS operating system.
- b. The CELL-DYN Ruby incorporates a mouse for software navigation, a 17 inch touch sensitive LCD display, and a hand held barcode reader for patient and control identification, where the CELL-DYN 3200 does not have any of these options.
- The CELL-DYN Ruby has software wizards which ﻦ step users through less routinely performed processes, while the CELL-DYN 3200 does not have this feature.
- d. The CELL-DYN Ruby has a CD-ROM or DVD Drive that allows the installation of software, and online maintenance videos and online help manual, while the CELL-DYN 3200 uses a floppy disk drive to download and upload information and does not have the online help capability.
- The CELL-DYN Ruby includes the ability to have e. interactions and remote instrument monitoring through AbbottLink, while the CELL-DYN 3200 only acts as a passive communicator and provides number of cycles performed on the analyzer.
- The CELL-DYN Ruby uses an increased size f. configuration of WBC Lyse reagent when compared to the current CELL-DYN 3200 configuration.
- g. The CELL-DYN Ruby Quality Control Moving Average programs (X-B) has been expanded to include PLT and RETC parameters and is capable of downloading reticulocytes QC to media for online peer QC Review, while the CELL-DYN 3200 does not have the same QC capability for Reticulocytes.
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| h. The CELL-DYN Ruby is able to search and filter the datalog and system log, while the CELL-DYN 3200 only searches patient demographics and does not have a system log. | |
|---|---|
| i. The CELL-DYN Ruby incorporates WOC and HGB reagent heaters to bring the reagents within a required temperature range while the CELL-DYN 3200 does not. | |
| Equivalency Data: | The analysis above supports the claim that the CELL-DYN Ruby System is substantially equivalent to the CELL-DYN 3200 System. |
| Data on file at Abbott Laboratories consisting of background, carryover, imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity information shows performance to the manufacturer's specifications. | |
| Conclusion: | The CELL-DYN Ruby System demonstrates substantial equivalence to the predicate device. |
| Truthful and Accurate Certification | A certification of the truthfulness and accuracy of the CELL-DYN Ruby System described in this submission is provided in Attachment I. |
.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Michelle Roeding Section Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054
JUL 1 0 2006
Re: K061667
Trade/Device Name: CELL-DYN RubyTM System Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential counter cell Regulatory Class: II Product Code: GKZ Dated: June 13, 2006 Received: June 14, 2006
Dear Ms. Roeding:
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 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). 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.
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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061667
Device Name: ___________CELL-DYN RubyTM System
Indications for Use:
The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters:
| White Blood Cell Parameters | Red Blood Cell Parameters | Hemoglobin Parameters |
|---|---|---|
| WBC - White Blood Cell Concentration | RBC - Red Blood Cell Concentration | HGB - Hemoglobin Concentration |
| NEU - Neutrophil Absolute | ||
| Concentration | HCT - Hematocrit | MCH - Mean Cell Hemoglobin |
| %N - Neutrophil Percentage of WBC | MCV - Mean Cell Volume | MCHC - Mean Cell Hemoglobin |
| Concentration | ||
| LYM - Lymphocyte Absolute | ||
| Concentration | RDW - Red Cell Distribution Width | |
| %L - Lymphocyte Percentage of WBC | %R - Reticulocyte Percent | |
| MONO - Monocyte Absolute | ||
| Concentration | RETC - Reticulocyte Absolute | |
| Concentration | ||
| %M - Monocyte Percentage of WBC | ||
| EOS - Eosinophil Absolute | ||
| Concentration | ||
| %E - Eosinophil Percentage of WBC | ||
| BASO - Basophil Absolute | ||
| Concentration | ||
| %B - Basophil Percentage of WBC | ||
| Platelet Parameters | ||
| PLT - Platelet Concentration | ||
| MPV - Mean Platelet Volume |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence OFCDRH, Offide of Device Evaluation (ODE)
Division Sign-Oif
Office of In Vitro Diagnostic Device
Evaluation and Safety
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