CELL-DYN EMERALD 22 SYSTEM

K110381 · Abbott Laboratories · GKZ · Dec 22, 2011 · Hematology

Device Facts

• Record ID: K110381
• Device Name: CELL-DYN EMERALD 22 SYSTEM
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Dec 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The CELL-DYN Emerald 22 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM # , MON%, MON # , NEU%, NEU #, EOS%, EOS # , BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood. The CELL-DYN Emerald 22 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Device Story

Bench-top automated hematology analyzer; processes K2EDTA anticoagulated whole blood samples via open-mode aspiration. System performs automated dilution and analysis to provide quantitative hematologic parameters (WBC, RBC, HGB, PLT, and 5-part differential). Principle of operation includes electrical impedance and optical analysis using a 455 nm LED. Operated by laboratory personnel in clinical settings. Data output includes histograms, dispersional data alerts, and critical limit flagging; interfaces with LIS via RS232/Ethernet. Provides clinicians with rapid hematologic profiles to assist in patient assessment and monitoring. Features include reagent lock-out, password protection, and integrated touch-screen interface.

Clinical Evidence

Clinical trial compared CELL-DYN Emerald 22 to CELL-DYN 3700. Evaluation included background, correlation, precision, linearity, and carryover performance metrics. Data supports substantial equivalence.

Technological Characteristics

Bench-top analyzer; electrical impedance sensing; flow cytometry (455 nm LED); absorption spectrophotometry (cyanide-free lytic reagent). Measures 22 parameters. Open tube sampling. Integrated data module, display, and printer. Software-based analysis of histograms and cell counts.

Indications for Use

Indicated for use in clinical laboratories to perform quantitative multi-parameter hematology analysis on K2EDTA anti-coagulated whole blood to identify patients with hematologic parameters within or outside established reference ranges.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• CELL-DYN 3700 System (k991605)

Submission Summary (Full Text)

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## 510(k) Summary

## CELL-DYN Emerald 22 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.

The assigned 510(k) number is:

| Submitted by | Contact Person |
|--------------------------|-------------------------------------------|
| Abbott Laboratories | Michelle Roeding |
| 5440 Patrick Henry Drive | Global Regulatory Affairs Section Manager |
| Santa Clara, CA 95054 | Phone: [phone] |
| | Fax: [phone] |

| Date Prepared: | August 2, 2011 |
|----------------------|-------------------------------------------------------|
| Proprietary Name: | CELL-DYN Emerald 22 System |
| Common Name: | Automated Hematology Analyzer |
| Classification Name: | Automated Differential Cell Counter (21 CFR 864.5220) |
| Predicate Device: | Abbott CELL-DYN 3700 System, K991605 |

#### Device Description:

The CELL-DYN Emerald 22 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 22 open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.

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### Intended Use

The CELL-DYN Emerald 22 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM # , MON%, MON # , NEU%, NEU #, EOS%, EOS # , BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.

The CELL-DYN Emerald 22 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

#### Similarities and Differences

The CELL-DYN Emerald 22 System and the CELL-DYN 3700 System are similar in that:

- Both systems aspirate the specimen from a collection tube, which contains the EDTAa) anticoagulated human whole blood specimen, and present it for automated processing.
- Both systems use microprocessors for systems control, data acquisition, and data b) analysis.
- Both systems provide RS232 interface to an on-line LIS. c)
- Both systems provide dispersional data alerts, suspect parameter messages, and critical d) limit flagging.
- Both systems use LED hemoglobin analysis. e)
- f) Both systems use a cyanide-free differential lyse reagent.
- Both systems are capable of inputting specimen information from a bar code through a g) hand held bar code scanner.
- Both systems are capable of data output to a printer. h)
- Both systems use optical analysis for the five-part white blood cell differential. i)

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The CELL-DYN Emerald 22 System and the CELL-DYN 3700 System are different in that:

- The CELL-DYN Emerald 22 is smaller and more compact than the CELL-DYN 3700. a)
- The CELL-DYN Emerald 22 is open mode and the CELL-DYN 3700 is open, or closed b) mode, and has the option of a sample loader.
- The CELL-DYN Emerald 22 has patient storage capacity of 1,000 records, while the c) CELL-DYN 3700 has a patient storage capacity of 10,000 run cycles.
- The CELL-DYN Emerald 22 has a touch screen and built in keypad, while the CELLd) DYN 3700 has an external keyboard and monitor.
- The CELL-DYN Emerald 22 has two USB ports, two serial ports and an internet port, e) while the CELL-DYN 3700 has a floppy drive and serial port for printing and data storage options.
- The CELL-DYN Emerald 22 has password protection to secure software fields, while the () CELL-DYN 3700 does not have password protection.
- The CELL-DYN Emerald 22 has a lock out feature to ensure expired reagents cannot be g) used on the system, while the CELL-DYN 3700 has no reagent lock out feature.
- The CELL-DYN Emerald 22 has 6 control files, while the CELL-DYN 3700 has 20 h) control files.
- The CELL-DYN Emerald 22 sample volume is 28 micro liters while the CELL-DYN i) 3700 nominal aspiration volume is 130 micro liters in open mode, and 240 micro liters in the closed mode.
- The CELL-DYN Emerald 22 uses a light emitting diode (LED) for optical analysis of the j) five-part white blood cell differential, while the CELL-DYN 3700 uses a He-Ne laser.

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- The CELL-DYN Emerald 22 does not measure reticulocytes, while the CELL-DYN 3700 k) does measure reticulocyte parameters.
## Similarities and Differences Table:

| | Predicate Device<br>CELL-DYN 3700 | Submission Device<br>CELL-DYN Emerald 22 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Bench top analyzer with built in<br>loader | Bench top analyzer |
| Instrument Size<br>Closed Sample Model | Height: 24 inches (61 cm)<br>Width: 30 inches (76 cm)<br>Depth: 22 inches (56 cm) | Height: 13.8 inches (35 cm)<br>Width: 9.8 inches (25 cm)<br>Depth: 13.8 inches (35 cm) |
| Instrument Size<br>Sample Loader Model | Height: 27 inches (68 cm)<br>Width: 30 inches (76 cm)<br>Depth: 31 inches (79 cm) | Not applicable |
| Intended Use | The CELL-DYN 3700 is a<br>multi-parameter, automated<br>hematology analyzer designed<br>for in vitro diagnostic use in<br>clinical laboratories. | The CELL-DYN Emerald 22<br>System is a quantitative multi-<br>parameter automated<br>hematology analyzer designed<br>for in-vitro-diagnostic use in<br>clinical laboratories for<br>enumeration of the following<br>parameters: WBC, LYM%,<br>LYM #, MON%, MON #,<br>NEU%, NEU #, EOS%, EOS<br>#, BAS%, BAS #, RBC, HCT,<br>MCV, RDW, HGB, MCH,<br>MCHC, PLT, MPV in K2EDTA<br>anti-coagulated whole blood.<br><br>The CELL-DYN Emerald 22 is<br>indicated for use to identify<br>patients with hematologic<br>parameters within and outside<br>of established reference ranges. |
| WBC differential | 5-part differential | Same |
| | Predicate Device<br>CELL-DYN 3700 | Submission Device<br>CELL-DYN Emerald 22 |
| Parameters | White Blood Cells:<br>WBC<br>LYM<br>LYM%<br>MONO<br>MONO%<br>NEU<br>NEU%<br>EOS<br>EOS%<br>BASO<br>BASO% | Same |
| | Red Blood Cells:<br>RBC<br>HCT<br>MCV<br>RDW | Same |
| | Hemoglobin:<br>HGB<br>MCH<br>MCHC | Same |
| | Platelets:<br>PLT<br>MPV | Same |
| | Reticulocyte:<br>RETIC<br>RETIC %<br>IRF | Not applicable |
| Technology | • Electrical impedance<br>• LED Hemoglobin Analysis at<br>555 nm<br>• Optical differential<br>• 5mW HeNe Laser | • Same<br>• Same<br>• Same<br>• 455 nm light emitting diode |
| Throughput | Approximately 90 per hour | Approximately 45 per hour |
| Sampling | Open or Closed Mode Analysis<br>Manual or loader presentation | Open Mode Analysis<br>Manual presentation and |
| | Predicate Device | Submission Device |
| | CELL-DYN 3700 | CELL-DYN Emerald 22 |
| | and aspiration of a well-mixed<br>whole blood specimen for<br>automated analysis; automatic<br>dilution of the aspirated sample<br>and automatic presentation of<br>each dilution for measurement. | aspiration of a well-mixed whole<br>blood specimen for automated<br>analysis; automatic dilution of<br>the aspirated sample and<br>automatic presentation of each<br>dilution for measurement. |
| Specimen Type | K3EDTA anticoagulated human<br>whole blood for all parameters | K2EDTA anticoagulated human<br>whole blood for all parameters |
| Sample Size | Open Mode Analysis 130 µL<br>Closed Mode Analysis 240 µL | Open Mode Analysis 28 µL |
| Reagents | Diluent<br>CN-Free Lyse Reagent<br>Enzymatic Cleaner<br>Detergent<br>Sheath Reagent<br>Reticulocyte Reagent | Diluent<br>CN-Free Lyse Reagent<br>CELL-DYN Easy Cleaner |
| | No reagent lock out feature | Reagents lock out feature to<br>ensure expired reagents cannot<br>be used on the system |
| Histograms | WBC, PLT, RBC | Same |
| Data Output/Input | Data Output:<br>Host RS232<br>Color Monitor external<br>Printer<br>Floppy drive<br>Data Input:<br>Keyboard<br>Bar code reader (optional) | Data Output:<br>Host RS232, Ethernet<br>Color LCD internal<br>Printer<br>USB<br>Data Input:<br>On screen Keypad<br>Bar code reader (standard) |
| Patient Data Storage | 10,000 cycles | 1,000 records |
| Alphanumeric Specimen<br>ID | Yes | Same |
| Quality Control | 20 files | 6 files |
| | Predicate Device<br>CELL-DYN 3700 | Submission Device<br>CELL-DYN Emerald 22 |
| Controls | CELL-DYN 26 Plus Control and<br>CELL-DYN HemCal Plus Calibrator | CELL-DYN 22 Plus Control and<br>CELL-DYN 22 Plus Calibrator |

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CELL-DYN Emerald 22 System
Traditional 510(k) Submission

510(k) Summary

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CELL-DYN Emerald 22 System
Traditional 510(k) Submission

510(k) Summary

·

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#### Equivalency Data Summary

The CELL-DYN Emerald 22 System is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald 22 System, which includes reagents and software, was compared to the CELL-DYN 3700 System in a clinical trial. The data compiled supports the claim that the CELL-DYN Emerald 22 System is substantially equivalent to the CELL-DYN 3700 System. The system evaluation included data for background, correlation, precision, linearity and carryover.

### Conclusion

The CELL-DYN Emerald 22 System is substantially equivalent to the CELL-DYN 3700 (predicate device). The differences noted between the systems do not pose new questions of safety and effectiveness.

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Image /page/7/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized abstract symbol that resembles a bird in flight or a series of flowing lines. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

DEC 8 2 2011

Re: k110381

Trade/Device Name: CELL-DYN Emerald 22 System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: December 21, 2011 Received: December 22, 2011

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 class II (Special Controls), 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 or any I 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Michelle Roeding

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Tina M. Chen

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

Enclosure

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# Indications for Use Form

510(k) Number (if known): _ KII 0 3 & 1

Device Name: CELL-DYN Emerald 22

Indications for Use:

The CELL-DYN Emerald 22 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM# , MON%, MON# , NEU%, NEU#, EOS% , EOS# , BAS%, BAS#, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.

The CELL-DYN Emerald 22 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Prescription Use _X Presertption Ose -------------------------------------------------------------------------------------------------------------------------------------------------------------

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 of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

in Clan

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

510(k) K110381

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