(70 days)
Abbott CELL-DYN 4000 System
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard hematology analyzer components and functions.
No
The device is described as an "in vitro diagnostic" hematology analyzer for use in clinical laboratories, which is used for analysis and not for treatment.
Yes
The "Intended Use / Indications for Use" states that it is "designed for in vitro diagnostic use in clinical laboratories."
No
The device description explicitly states it is a "benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents," indicating it is a hardware system with software components, not a software-only device.
Yes, the CELL-DYN Sapphire System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories."
- Nature of the Device: The device is a hematology analyzer that performs tests on EDTA-anticoagulated whole blood. This is a classic example of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health.
- Clinical Laboratory Setting: The intended use specifies that the device is for use in clinical laboratories, which is the typical setting for performing IVD tests.
The information provided strongly indicates that the CELL-DYN Sapphire System is intended for diagnostic purposes performed on samples taken from the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode.
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
in clinical 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)
The CELL-DYN Sapphire System, which includes reagents and software, was compared in clinical trials to the CELL-DYN 4000 System. The data compiled supports the claim that the CELL-DYN Sapphire System is substantially equivalent to the CELL-DYN 4000 System and includes data for background, carryover, comparability (correlation), imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity and specificity
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.
Abbott CELL-DYN 4000 System
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.”
0
JUL 2 1 2005
| 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. |
|---|---|
| The assigned 510(k) number is: K051215 | |
| CELL-DYN Sapphire™ 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 | May 10, 2005 |
| Proprietary Name | CELL-DYN Sapphire™ System |
| Common Name | Automated Hematology Analyzer |
| Classification Name | Automated Differential Cell Counter (21 CFR 864.5220) |
| Predicate Device | Abbott CELL-DYN 4000 System |
| Device Description | The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode. |
... . .....
1
| Intended Use | | The CELL-DYN Sapphire System is a multiparameter,
automated hematology analyzer designed for in vitro
diagnostic use in clinical laboratories.
The CELL-DYN Sapphire System has the same intended use
as previously cleared for the CELL-DYN 4000 System
(predicate device). |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities
And
Differences | | The CELL-DYN Sapphire System and the CELL-DYN 4000
System are similar in that: |
| | a) | Both systems provide quantitation of the hemogram and
automated WBC differential parameters in EDTA-
anticoagulated human whole blood specimens. |
| | b) | Both systems will accept specimens presented automatically by
the autoloader or manually presented by the operator. |
| | c) | Both systems utilize multiple measurement methodologies:
impedance, laser optical scatter, fluorescence, and optical
absorbance methods. |
| | d) | Both systems measure RBC and PLT by laser optical scatter
and focused-flow impedance with injection metering. |
| | e) | Both systems measure WBC by laser optical scatter and
fluorescence. |
| | f) | Both systems use fluorescence to enumerate reticulocytes,
NRBC, CD61, and CD3/4/8. |
| | g) | Both systems provide Dispersional Data Alerts, Suspect
Parameter Messages, and Suspect Population Flags to assist in
data review. |
| | h) | Both systems accept input from keyboard and send 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. |
| | | The CELL-DYN Sapphire System and the CELL-DYN 4000
System are different in that: |
| | a) | The CELL-DYN Sapphire System uses a solid state laser to
facilitate both optical scatter and fluorescence measurements |
| b) | The CELL-DYN Sapphire System uses a Unix based Linux
operating system, while the CELL-DYN 4000 uses a Unix
based Lynx operating system. | |
| c) | The CELL-DYN Sapphire System has the ability to download
raw list mode data (FCS type) to media for analysis, while the
CELL-DYN 4000 System does not have this capability. | |
| d) | The CELL-DYN Sapphire System has internal pneumatic
components, while the CELL-DYN 4000 has a separate
external pneumatic unit. | |
| Medical - Clinical
Study Protocol | The Medical - Clinical Study Protocols for the CELL-DYN
Sapphire are found in Attachment E. | |
| Equivalency
Data Summary | The CELL-DYN Sapphire System is a multiparameter,
automated hematology analyzer designed for in vitro
diagnostic use in clinical laboratories. The CELL-DYN
Sapphire System, which includes reagents and software, was
compared in clinical trials to the CELL-DYN 4000 System.
The data compiled supports the claim that the CELL-DYN
Sapphire System is substantially equivalent to the CELL-DYN
4000 System and includes data for background, carryover,
comparability (correlation), imprecision (reproducibility),
analytical measurement range (linearity), and sensitivity and
specificity. The data supporting the claim that the
CELL-DYN Sapphire is substantially equivalent to the
CELL-DYN 4000 is found in Attachment G. | |
| Conclusion | The CELL-DYN Sapphire System is substantially equivalent to
the CELL-DYN 4000 (predicate device). The differences
noted do not pose new questions of safety and effectiveness. | |
while the CELL-DYN 4000 uses an Argon-ion laser.
:
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Michelle Roeding Section Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive . . . . . . JE E & 2005
JUL 2 1 2005
Hematology Business Unit Santa Clara, CA 95054
=
Re: K051215
Trade/Device Name: CELL- DYN Sapphire™ System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: May 10, 2004 Received: May 12, 2004
Dear Ms. Rocding:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection o re(a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regardy the Medical Device Amendments, or to conninered pror to May 20, 2019, 11:25 eccordance with the provisions of the Federal Food, Drug, de necs that have been rout do not require approval of a premarket approval application (PMA). and Cosment Act (710c) that the novice, subject to the general controls provisions of the Act. The r ou may, diererors, mains of the Act include requirements for annual registration, listing of general controls proving 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 your de subject to such additional controls. Existing major regulations affecting your device n may oc subject it outer also a and 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 or uny I vith 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 requirements as bet form in keting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you destro species and advertising of your device, please contact the Office of In or questions on the proce Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (24€PR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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 vours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K
510(k) Number (if known): K05/215
. ... . . . . .
Device Name:
CELL-DYN Sapphire™ System
ﺘﺸﻐﻴﻨﺎﺕ ﺑﺘﺤﻘ
Indications for Use:
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.
(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) | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K051215 |
|---|---|
| -------- | --------- |
005CELL-DYN Sapphire™ System Traditional 510(k) Submission