K Number
K081495
Device Name
CELL-DYN EMERALD SYSTEM
Date Cleared
2009-02-04

(251 days)

Product Code
Regulation Number
864.5220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CELL-DYN Emerald System is an automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.
Device Description
The CELL-DYN Emerald System is a bench top analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module. The CELL-DYN Emerald open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.
More Information

Not Found

No
The summary does not mention AI, ML, or any related technologies, and the description focuses on standard hematology analyzer components and performance studies comparing it to a predicate device.

No
The device is described as an automated hematology analyzer designed for in vitro diagnostic use, which means it analyzes samples for diagnostic purposes rather than directly treating a condition.

Yes
The "Intended Use / Indications for Use" states that the system is "designed for in vitro diagnostic use in clinical laboratories."

No

The device description clearly states it is a bench top analyzer consisting of hardware components like a main analyzer, data module, display station, and printer.

Yes, based on the provided text, the CELL-DYN Emerald System is an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use / Indications for Use: The very first sentence explicitly states: "The CELL-DYN Emerald System is an automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories." This is the most direct and definitive indicator.
  • Device Description: The description mentions it's a "bench top analyzer" that aspirates "blood from a collection tube." This aligns with the typical function of an IVD device used to analyze biological samples outside of the body.
  • Intended User / Care Setting: It's intended for use in "clinical laboratories," which is the standard setting for performing in vitro diagnostic tests.

The other sections, while providing details about the device, don't contradict the initial statement and further support its classification as an IVD.

N/A

Intended Use / Indications for Use

The CELL-DYN Emerald System is an automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Product codes (comma separated list FDA assigned to the subject device)

GKZ

Device Description

The CELL-DYN Emerald System is a bench top analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module.

The CELL-DYN Emerald open sampler is equipped to aspiratc blood from a collection tube that has been opened and is held under the open sample aspiration probe.

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.

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 Emerald System, which includes reagents and software, was compared in both external as well as an internal clinical trial to the CELL-DYN 1800 System. The data compiled supports the claim that the CELL-DYN Emerald System is substantially equivalent to the CELL-DYN 1800 System and includes data for background, correlation, precision, linearity and carryover.

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.

Abbott CELL-DYN® 1800 System, K030513

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

510(k) Summary

CELL-DYN Emerald™ System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Contact Person

The assigned 510(k) number is:

f1495

Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, CA 95054

Michelle Roeding Section Manager, Regulatory Affairs Phone: (408) 567-3781 Fax: (408) 982-4863

Date Prepared:

Submitted by

December 23, 2008

CELL-DYN Emerald™ System

Automated Hematology Analyzer

Proprietary Name:

Common Name:

Automated Differential Cell Counter (21 CFR 864.5220)

Predicate Device:

Classification Name:

Abbott CELL-DYN® 1800 System, K030513

Device Description:

The CELL-DYN Emerald System is a bench top analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module.

The CELL-DYN Emerald open sampler is equipped to aspiratc blood from a collection tube that has been opened and is held under the open sample aspiration probe.

CELL-DYN Emerald™ System Traditional 510(k) Submission Page 1 of 6

510(k) Summary

1

Intended Use

The CELL-DYN Emerald System is an automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Similarities and Differences

The CELL-DYN Emerald System and the CELL-DYN 1800 System are similar in that:

  • Both systems are bench top 3-part differential hematology with built-in monitors and data station.
    Both systems analyze 16 parameters (measurands).

Both systems accept open specimens presented manually by the operator.

  • Both systems automatically aspirate the specimen and present it for automated processing.
  • Both systems use microprocessors for systems control, data acquisition, and data analysis.

Both systems provide RS232 interface to an on-line LIS.

  • Both systems provide Histograms, Dispersional Data Alerts, Suspect Parameter Messages, and Critical Limit Flagging.
  • Both systems use electrical impedance technology for counting and sizing cells.

Both systems use LED Hemoglobin analysis.

Both systems use a Cyanide-Free differential lyse reagent.

  • Both systems are capable of inputting specimen information from a bar code through a hand held bar code scanner and both systems use alphanumeric specimen ID's.
    Both systems are capable of data output to a dot matrix or inkjet printer.

The CELL-DYN Emerald System and the CELL-DYN 1800 System are different in that:

The CELL-DYN Emerald analyzer is smaller and more compact than the CELL-DYN 1800.

2

  • The CELL-DYN Emerald System has a touch screen and built-in keypad while the CELL-DYN 1800 has an external keyboard.
  • The CELL-DYN Emerald System has two USB ports and one serial port while the CELL-DYN 1800 System has a floppy drive and serial port for printing and data storage options.

The CELL-DYN Emerald System uses different boards and microprocessors.

  • The CELL-DYN Emerald System has a password protection to secure software fields while the CELL-DYN 1800 does not have password protection.
  • The CELL-DYN Emerald Cleaner reagent contains an enzymatic agent while the CELL-DYN 1800 has a separate enzymatic cleaner.
  • The CELL-DYN Emerald aspirates K2EDTA-anticoagulated human whole blood specimens while the CELL-DYN 1800 uses K3EDTA-anticoagulated human whole blood specimens.
  • The CELL-DYN Emerald sample size is approximately 9.8 micro liters while the CELL-DYN 1800 is approximately 30 micro liters.

Similarities and Differences Table:

| | Predicate Device
Abbott CELL-DYN® 1800 | Submission Device
CELL-DYN Emerald™ |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Bench top analyzer with built-in
monitor and data station | Same |
| Instrument Size | Height: 17 inches (44 cm)
Width: 26 inches (66 cm)
Depth: 21 inches (53 cm) | Height: 13.8 inches (35 cm)
Width: 9.8 inches (25 cm)
Depth: 13.8 inches (35 cm) |
| Intended Use | The CELL-DYN 1800 is a
multi-parameter, automated
hematology analyzer designed
for in vitro diagnostic use in
clinical laboratories. | The CELL-DYN Emerald is an
automated hematology analyzer
designed for in vitro diagnostic
use in clinical laboratories. |
| | Predicate Device
Abbott CELL-DYN® 1800 | Submission Device
CELL-DYN Emerald™ |
| WBC Differential | 3-Part Differential | Same |
| Parameters | White Blood Cells:
• WBC • GRAN
• LYM • %GRAN
• %LYM
• MID
• %MID | Same |
| | Red Blood Cells:
• RBC • MCV
• HCT • RDW | |
| | Hemoglobin:
• HGB
• MCH
• MCHC | |
| | Platelets:
• PLT
• MPV | |
| Technology | • Electrical impedance | Same |
| | • LED Hemoglobin Analysis | Same |
| | • Lysate modified differential | Same |
| | • Modified Methemoglobin for
hemoglobin measurement | Same |
| | • Boards: Single Board
Computed | • Boards: Pre-Amp, CPU,
IHM |
| | • Microprocessor: Celeron 850
MHz | • Microprocessor: Freescale
Coldfire |
| | • No Password Protection | • Password Protection |
| Time to First Result | Approximately 60 seconds | Same |
| Sampling / Dilution | Open Mode Analysis:
Manual presentation and
aspiration of a well-mixed whole
blood specimen for automated | Open Mode Analysis:
Manual presentation and
aspiration of a well-mixed whole
blood specimen for automated |
| | Predicate Device | Submission Device |
| | Abbott CELL-DYN® 1800 | CELL-DYN Emerald™ |
| | analysis; automatic dilution of
the aspirated sample and
automatic presentation of each
dilution for measurement. | analysis; automatic dilution of
the aspirated sample and
automatic presentation of each
dilution for measurement. |
| | Pre-Dilute Mode Analysis:
Off line dilution of whole blood
specimen and manual
presentation of each dilution for
measurement; manual
presentation and aspiration of
pre-diluted sample for automated
analysis. | |
| Specimen Type | K3EDTA-anticoagulated human
whole blood for all parameters | K2EDTA-anticoagulated human
whole blood for all parameters |
| Sample Size | Open Mode Analysis:
30 µL
Pre-Dilute Mode Analysis:
40 µL | Open Mode Analysis:
9.8µL |
| Reagents | • Detergent
• Diluent
• CN-Free Lyse Reagent | • Cleaner (with enzymes)
• Diluent
• CN-Free Lyse Reagent |
| Histograms | RBC, WBC, PLT | Same |
| Data Output / Data
Input Interface | Data Output:
• Host RS232
• Color Monitor
• Dot Matrix Printer
• Inkjet Printer
• Diskettes
Data Input:
• Keyboard (external)
• Bar code reader (optional) | Data Output:
• Host RS232
• Ethernet
• Color Monitor
• Dot Matrix Printer
• Inkjet Printer
• USB Printer
Data Input:
• Keypad (internal)
• Bar code reader (standard) |
| Alphanumeric
Specimen ID | Yes | Same |
| | Predicate Device
Abbott CELL-DYN® 1800 | Submission Device
CELL-DYN Emerald™ |
| Electrical, Mechanical,
and Thermal Safety | System certification to US and
Canadian product safety
standards and EU low voltage
safety standards | Same |

CELL-DYN Emerald™ System Traditional 510(k) Submission

510(k) Summary

3

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510(k) Summary

: ·

4

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100 - 100 - 100

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510(k) Summary

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5

Equivalency Data Summary

The CELL-DYN Emerald System is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald System, which includes reagents and software, was compared in both external as well as an internal clinical trial to the CELL-DYN 1800 System. The data compiled supports the claim that the CELL-DYN Emerald System is substantially equivalent to the CELL-DYN 1800 System and includes data for background, correlation, precision, linearity and carryover. Refer to Medical Clinical Summary Report (Attachment F) for the data supporting the substantially equivalent claim between the CELL-DYN Emerald and the CELL-DYN® 1800.

Conclusion

The CELL-DYN Emerald System is substantially equivalent to the CELL-DYN® 1800 (predicate device). The differences noted do not pose new questions of safety and effectiveness.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 4 2009

Abbott Laboratories c/o Ms Michelle B. Roeding Section Manager, Regulatory Affairs 5440 Patrick Henry Drive Santa Clara, CA 95054

Re: K081495

Trade/Device Name: Cee-Dyn Emerald™ System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: January 16, 2009 Received: January 21, 2009

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.

7

Page 2 - Ms. Michelle B. Roeding

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Monroe M Chapp.

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

8

Indication for Use

510(k) Number (if known): K081495

Device Name:

CELL-DYN Emerald™ System

Indication For Use:

The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Ja Vitry Diggnostic Device Evaluation and Safety (OVD)

Doughine Bautisti

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081495