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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CELL-DYN Emerald 22 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for each parameter. Instead, it describes a "substantial equivalence" study where the CELL-DYN Emerald 22 System was compared to the predicate device, the CELL-DYN 3700 System. The study's conclusion is that the device is substantially equivalent.

Therefore, the "acceptance criteria" were implicitly met if the performance of the Emerald 22 was deemed comparable to the legally marketed 3700. The text states:

"The system evaluation included data for background, correlation, precision, linearity and carryover."

Lack of specific criteria is common in 510(k) summaries when demonstrating substantial equivalency to a predicate device. The performance is deemed acceptable if it aligns with the established predicate's performance.

Parameter	Acceptance Criteria (Implicit: Comparable to CELL-DYN 3700)	Reported Device Performance
Background	Performance comparable to CELL-DYN 3700	Data supports substantial equivalence
Correlation	Performance comparable to CELL-DYN 3700	Data supports substantial equivalence
Precision	Performance comparable to CELL-DYN 3700	Data supports substantial equivalence
Linearity	Performance comparable to CELL-DYN 3700	Data supports substantial equivalence
Carryover	Performance comparable to CELL-DYN 3700	Data supports substantial equivalence
Overall	Substantially Equivalent to CELL-DYN 3700	"The CELL-DYN Emerald 22 System is substantially equivalent to the CELL-DYN 3700 (predicate device)."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "a clinical trial" where the device was compared to the predicate, but it does not specify the sample size used for this test set.

The data provenance is not explicitly stated regarding country of origin. The submission is to the FDA in the USA, implying US regulatory context. It's likely a prospective study, as it's a "clinical trial" for a new device comparison, but this is not definitively stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study framework is a comparison of the new device's measurements against a predicate device's measurements, not against an expert-established "ground truth" for individual parameters.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a comparison study between two automated hematology analyzers, an adjudication method for individual parameter values is typically not applicable in the same way it would be for, say, image analysis interpreted by humans. The comparison would involve statistical methods to assess agreement or correlation between the two devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. The CELL-DYN Emerald 22 System is an automated hematology analyzer, not an AI-assisted diagnostic tool that human readers would interact with. The study compares the new automated device to an existing automated device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone performance study. The CELL-DYN Emerald 22 System is an "automated hematology analyzer" performing quantitative measurements. The study evaluated its performance (background, correlation, precision, linearity, carryover) in comparison to another automated device, without direct human intervention in the primary measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device, the CELL-DYN 3700 System. The study aims to demonstrate that the new device's measurements are substantially equivalent to those of the predicate, which is already a legally marketed and presumably validated device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Automated hematology analyzers like the CELL-DYN Emerald 22 are typically built on established physical and chemical principles (e.g., electrical impedance, optical analysis for cell counting, hemoglobin analysis). They do not usually involve "training sets" in the machine learning sense to develop their core algorithms for parameter enumeration. Their algorithms are based on physics and chemistry, not learned from large datasets in the way an AI diagnostic model would be.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the reasons stated above.

Summary

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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: (408) 567-3781
	Fax: (408) 588-2927

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 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 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 DeviceCELL-DYN 3700	Submission DeviceCELL-DYN Emerald 22
Device Description	Bench top analyzer with built inloader	Bench top analyzer
Instrument SizeClosed Sample Model	Height: 24 inches (61 cm)Width: 30 inches (76 cm)Depth: 22 inches (56 cm)	Height: 13.8 inches (35 cm)Width: 9.8 inches (25 cm)Depth: 13.8 inches (35 cm)
Instrument SizeSample Loader Model	Height: 27 inches (68 cm)Width: 30 inches (76 cm)Depth: 31 inches (79 cm)	Not applicable
Intended Use	The CELL-DYN 3700 is amulti-parameter, automatedhematology analyzer designedfor in vitro diagnostic use inclinical laboratories.	The CELL-DYN Emerald 22System is a quantitative multi-parameter automatedhematology analyzer designedfor in-vitro-diagnostic use inclinical laboratories forenumeration of the followingparameters: WBC, LYM%,LYM #, MON%, MON #,NEU%, NEU #, EOS%, EOS#, BAS%, BAS #, RBC, HCT,MCV, RDW, HGB, MCH,MCHC, PLT, MPV in K2EDTAanti-coagulated whole blood.The CELL-DYN Emerald 22 isindicated for use to identifypatients with hematologicparameters within and outsideof established reference ranges.
WBC differential	5-part differential	Same
	Predicate DeviceCELL-DYN 3700	Submission DeviceCELL-DYN Emerald 22
Parameters	White Blood Cells:WBCLYMLYM%MONOMONO%NEUNEU%EOSEOS%BASOBASO%	Same
	Red Blood Cells:RBCHCTMCVRDW	Same
	Hemoglobin:HGBMCHMCHC	Same
	Platelets:PLTMPV	Same
	Reticulocyte:RETICRETIC %IRF	Not applicable
Technology	• Electrical impedance• LED Hemoglobin Analysis at555 nm• Optical differential• 5mW HeNe Laser	• Same• Same• Same• 455 nm light emitting diode
Throughput	Approximately 90 per hour	Approximately 45 per hour
Sampling	Open or Closed Mode AnalysisManual or loader presentation	Open Mode AnalysisManual presentation and
	Predicate Device	Submission Device
	CELL-DYN 3700	CELL-DYN Emerald 22
	and aspiration of a well-mixedwhole blood specimen forautomated analysis; automaticdilution of the aspirated sampleand automatic presentation ofeach dilution for measurement.	aspiration of a well-mixed wholeblood specimen for automatedanalysis; automatic dilution ofthe aspirated sample andautomatic presentation of eachdilution for measurement.
Specimen Type	K3EDTA anticoagulated humanwhole blood for all parameters	K2EDTA anticoagulated humanwhole blood for all parameters
Sample Size	Open Mode Analysis 130 µLClosed Mode Analysis 240 µL	Open Mode Analysis 28 µL
Reagents	DiluentCN-Free Lyse ReagentEnzymatic CleanerDetergentSheath ReagentReticulocyte Reagent	DiluentCN-Free Lyse ReagentCELL-DYN Easy Cleaner
	No reagent lock out feature	Reagents lock out feature toensure expired reagents cannotbe used on the system
Histograms	WBC, PLT, RBC	Same
Data Output/Input	Data Output:Host RS232Color Monitor externalPrinterFloppy driveData Input:KeyboardBar code reader (optional)	Data Output:Host RS232, EthernetColor LCD internalPrinterUSBData Input:On screen KeypadBar code reader (standard)
Patient Data Storage	10,000 cycles	1,000 records
Alphanumeric SpecimenID	Yes	Same
Quality Control	20 files	6 files
	Predicate DeviceCELL-DYN 3700	Submission DeviceCELL-DYN Emerald 22
Controls	CELL-DYN 26 Plus Control andCELL-DYN HemCal Plus Calibrator	CELL-DYN 22 Plus Control andCELL-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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

§ 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.”