CELL-DYN Emerald 22 AL System

K190294 · Abbott Laboratories · GKZ · Mar 15, 2019 · Hematology

Device Facts

• Record ID: K190294
• Device Name: CELL-DYN Emerald 22 AL System
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Mar 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The CELL-DYN Emerald 22 System is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.

Device Story

CELL-DYN Emerald 22 System; automated hematology analyzer; performs quantitative blood analysis and leukocyte differential counting. Modification adds sample autoloader for automated sample processing; includes rack transfer, mixing, and unloading. Modifications involve open/close tube operation, sampling module, operating system, and system board. Used in clinical laboratories; operated by laboratory personnel. Output provides hematological data for clinical decision-making regarding patient blood health.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical design verification and analytical performance testing, including background, carryover, linearity, short/long-term imprecision, method comparison, blood tube type study, mode-to-mode equivalency, and clogging rate analysis.

Technological Characteristics

Bench-top analyzer; electrical impedance, absorption spectrophotometry (555nm LED), and optical flow cytometry (455nm LED). Autoloader module for 50-tube capacity; trocar needle for cap piercing. CPU: Phytec Freescale i.MX27, ARM926EJ, 400MHz+. Connectivity: USB ports for external storage/peripherals, LIS integration. Software: OSE Delta operating system. Dimensions: 16.1" x 19.7" x 17.0".

Indications for Use

Indicated for use in clinical laboratories to identify patients with hematologic parameters within and outside of established reference ranges using K2EDTA anticoagulated whole blood.

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 Emerald 22 system (K110381)

Submission Summary (Full Text)

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March 15, 2019

Abbott Laboratories Madhu Gill Regulatory Affairs Specialist 4551 Great America Pkwy Santa Clara, California 95054

Re: K190294

Trade/Device Name: CELL-DYN Emerald 22 AL System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: February 8, 2019 Received: February 11, 2019

Dear Madhu Gill:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Takeesha Taylor-bell -S

Takeesha Taylor-Bell Chief. Hematology Branch Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190294

Device Name CELL-DYN Emerald 22 AL System

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 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 21CFR 807.92

The assigned 510(k) number is: K190294

| I | Submitter | Abbott Laboratories<br>4551 Great America Pkwy<br>Santa Clara, CA 95054<br>Phone: [phone]; Fax: [phone]<br>Contact Person: Madhu Gill<br>Date Prepared: February 12, 2019 |
|-----|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II | Device | Trade Name: CELL-DYN Emerald 22 AL System<br>Common Name: Automated Hematology Analyzer<br>Device Classification: Class II GKZ – Automated Differential Cell<br>Counter (21 CFR 864.5220)<br>Trade Marks: CELL-DYN Emerald is a trademark of Abbott Laboratorie |
| III | Predicate Device<br>and 510(k)<br>number | The predicate device is CELL-DYN Emerald 22 system, K110381,<br>cleared December 22, 2011. |

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## IV. Intended Use/ Indications for Use

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

### V. Device Description

The CELL-DYN Emerald 22 AL analyzer is a bench top analyzer, consisting of the main analyzer, autoloader module, and touch screen display. Sample analysis may be performed in open or closed mode. The CELL-DYN Emerald 22 AL is equipped with a sample loader that provides continuous automated closed mode sampling for up to 50 closed tube samples, one at a time. The analyzer is also equipped with a tube holder assembly that allows the use of open tube sampling.

The CELL-DYN Emerald 22 AL is designed to automatically perform the following:

- a) Aspirate and dilute whole blood
- b) Count, size and classify cells present in a whole blood specimen
- c) Measure the hemoglobin concentration of a whole blood specimen
- d) Analyze the raw data that is collected
- e) Output results to the display, printer and laboratory information system

Three types of measurements are used to count, size and classify blood cells and to measure hemoglobin. The three types of measurements are:

- a) Electrical Impedance Counting
- b) Absorption Spectrophotometry
- c) Optical Flow Cytometry

The electrical impedance counting is used for WBC, RBC and PLT measurements. The absorption spectrophotometry is used for HGB measurement. The optical flow cytometry is used

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for WBC differential. HCT is derived from the volume of the RBCs that are counted during the measurement cycle.

The CELL-DYN Emerald 22 AL provides the following parameters:

White Blood Cell Parameters

- WBC White Blood Cell or leukocyte count .
- LYM % Lymphocyte percent* ●
- LYM # Lymphocyte absolute number* ●
- . MON % Monocyte percent*
- . MON # Monocyte absolute number*
- NEU % Neutrophil percent*
- NEU # Neutrophil absolute number*
- EOS% Eosinophil percent*
- EOS # Eosinophil absolute number*
- BAS % Basophil percent*
- . BAS # Basophil absolute number*

* WBC differential parameters are measured and reported in DIF mode only.

Red Blood Cell Parameters

- RBC Red Blood Cell or erythrocyte count
- HCT Hematocrit ●
- MCV Mean Cell Volume
- RDW Red Blood Cell Distribution Width

Hemoglobin Parameters

- HGB Hemoglobin concentration ●
- . MCH Mean Cell Hemoglobin
- MCHC Mean Cell Hemoglobin Concentration

#### Platelet Parameters

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- . PLT Platelet count
- MPV Mean Platelet Volume .

## VI. Summary of Substantial Equivalence:

Table 4.1 below compares the CELL-DYN Emerald 22 AL with the predicate device, CELL-DYN Emerald 22 (K110381).

Table 4.1: Similarities and differences between CELL-DYN Emerald 22 AL System and CELL-DYN Emerald 22 System (K110381).

| Item | Predicate device, CELL-DYN<br>Emerald 22 (K110381) | Modified device, CELL-DYN<br>Emerald 22 AL | | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | | | |
| Intended Use/<br>Indications<br>for Use | The CELL-DYN Emerald 22 System<br>is a quantitative multi-parameter<br>automated hematology analyzer<br>designed for in-vitro diagnostic use in<br>clinical laboratories for enumeration<br>of the following parameters: WBC,<br>LYM%, LYM #, MON%, MON #,<br>NEU%, NEU #, EOS%, EOS #,<br>BAS%, BAS #, RBC, HCT, MCV,<br>RDW, HGB, MCH, MCHC, PLT,<br>MPV in K2EDTA anti-coagulated<br>whole blood.<br><br>The CELL-DYN Emerald 22 is<br>indicated for use to identify patients<br>with hematologic parameters within<br>and outside of established reference<br>ranges. | The CELL-DYN Emerald 22 AL<br>System is a quantitative multi-<br>parameter automated hematology<br>analyzer designed for in-vitro<br>diagnostic use in clinical laboratories<br>for enumeration of the following<br>parameters: WBC, LYM%, LYM #,<br>MON%, MON #, NEU%, NEU #,<br>EOS%, EOS #, BAS%, BAS #, RBC,<br>HCT, MCV, RDW, HGB, MCH,<br>MCHC, PLT, MPV in K2EDTA anti-<br>coagulated whole blood.<br><br>The CELL-DYN Emerald 22 AL is<br>indicated for use to identify patients<br>with hematologic parameters within<br>and outside of established reference<br>ranges. | | |
| Item | Predicate device, CELL-DYN | Modified device, CELL-DYN | | |
| | Emerald 22 (K110381) | Emerald 22 AL | | |
| WBC<br>differential | 5-part differential | 5-part differential | | |
| | Parameters | White Blood Cells: | White Blood Cells: | |
| WBC | | WBC | | |
| LYM% | | LYM% | | |
| LYM # | | LYM # | | |
| MON% | | MON% | | |
| MON # | | MON # | | |
| NEU% | | NEU% | | |
| NEU # | | NEU # | | |
| EOS% | | EOS% | | |
| EOS # | | EOS # | | |
| BAS% | | BAS% | | |
| BAS # | | BAS # | | |
| Red Blood Cells: | | Red Blood Cells: | | |
| RBC | | RBC | | |
| HCT | | HCT | | |
| MCV | | MCV | | |
| RDW | | RDW | | |
| Hemoglobin: | | Hemoglobin: | | |
| HGB | | HGB | | |
| MCH | | MCH | | |
| MCHC | | MCHC | | |
| Platelets: | | Platelets: | | |
| PLT | | PLT | | |
| MPV | | MPV | | |
| Item | Predicate device, CELL-DYN<br>Emerald 22 (K110381) | Modified device, CELL-DYN<br>Emerald 22 AL | | |
| Technology | Optical differential by LED 455nm<br>Electric impedance<br>Spectrophotometry by LED 555nm | Optical differential by LED 455nm<br>Electric impedance<br>Spectrophotometry by LED 555nm | | |
| Sample Type | K2EDTA anticoagulated human<br>whole blood for all parameters | K2EDTA anticoagulated human<br>whole blood for all parameters | | |
| Reagents | CELL-DYN Emerald 22 Diluent<br>CELL-DYN Emerald 22 Lyse<br>CELL-DYN Emerald 22 Easy<br>Cleaner | CELL-DYN Emerald 22 Diluent<br>CELL-DYN Emerald 22 Lyse<br>CELL-DYN Emerald 22 Easy<br>Cleaner | | |
| Controls and<br>Calibrator | CELL-DYN 22 Plus Control<br>CELL-DYN 22 Plus Calibrator | CELL-DYN 22 Plus Control<br>CELL-DYN 22 Plus Calibrator | | |
| Histograms | WBC, PLT, RBC | WBC, PLT, RBC | | |
| Scatterplot | WBC | WBC | | |
| Alphanumeric<br>Specimen ID | Feature Available | Feature Available | | |
| Differences | | | | |
| Sample<br>loading<br>mechanism | Individual uncapped tube samples are<br>manually presented to the sample<br>probe for aspiration. | Autoloader assembly was added to<br>allow for loading up to 50 closed tube<br>samples at a time. The autoloader<br>assembly includes the following<br>modules/components:<br>- Sample racks<br>- Loader<br>- Transfer/mixer<br>- Unloader<br>- Internal bar code reader<br>- Frames and covers | | |
| Item | Predicate device, CELL-DYN<br>Emerald 22 (K110381)…