The CellSearch™ Epithelial Cell Control kit is intended for use as an assayed control, when performing the CellSearch™ Epithelial Cell Kit on the CellTracks® AutoPrep System, to ensure that the sample detection and identification systems are working. For in vitro diagnostic use.

Device Description

The CellSearch™ Epithelial Cell Control contains single-use vials of fixed cells from a breast carcinoma cell line (SKBR-3). Each vial contains two populations of cells for high and low level control. A CellSearch™ Epithelial Cell Control vial is substituted for a patient sample to verify the performance of the CellSearch™Epithelial Cell Kit reagents (K031588), sample processing by the CellTracks® AutoPrep System (K040077), and cell analysis by the CellSpotter® Analyzer(K031588).

Each single use vial in the CellSearch™ Epithelial Cell Control Kit contains two populations of SKBR-3 cells at different concentrations (low and high). The two cell populations are distinguished from each other by use of fluorescent dyes that are specific for each population. This permits simultaneous enumeration of low and high control cell populations by the CellSpotter® Analyzer. The control cells are fully compatible with CellSearch™ Epithelial Cell Kit reagents and are magnetically captured by the CellSpotter® Analyzer and acquired as images that are displayed to the user for final classification. The cells are differentiated as control cells by the detection of fluorescence in the high or low control channels of the CellSpotter® Analyzer.

The CellSearch™ Epithelial Cell Control Kit contains 24 single-use bottles of CellSearch™ Epithelial Cell Controls. Each bottle contains 3.5 mL of two populations of fixed SKBR-3 cells (a human breast carcinoma derived cell line) in Histopaque®(Sigma Aldrich Trademark), 5% bovine serum albumin and 0.1% sodium azide.

AI/ML Overview

The document describes the CellSearch™ Epithelial Cell Control Kit, an assayed control for the CellSearch™ Epithelial Cell Kit assay. The primary study described aims to demonstrate the control's function, the substantial equivalence of its matrix to whole blood for the CellSearch Assay, and acceptable precision.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, consolidated format. However, it states the purpose of the control kit and the types of performance data assessed.

Acceptance Criteria (Implied)	Reported Device Performance
Control Functionality: Ability to assess the performance of the CellSearch™ Epithelial Cell Kit, CellTracks® AutoPrep System, and CellSpotter® Analyzer in detecting and enumerating circulating tumor cells (CTC).	"performance data that describes the assessment done to verify the CellSearch™ Epithelial Cell Control function" and "The assay results support that the controls can monitor that assay performance is working." (Specific metrics for "working" are not detailed in this summary.)
Matrix Equivalence: The control matrix (Histopaque®) is substantially equivalent to whole blood for the CellSearch Assay.	"demonstration that the Control Matrix is substantially equivalent to whole blood for the CellSearch Assay" (Specific metrics or comparison data are not detailed in this summary.)
Precision: Acceptable precision of the control kit.	"and has acceptable precision." (Specific metrics for "acceptable precision" are not detailed in this summary.)
Expected Target Values: Two populations of cells; High (1000 cells/test); Low (50 cells/test).	This is a design characteristic rather than an acceptance criterion result itself, but implies the device should consistently demonstrate these target values within acceptable ranges.

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

Sample Size: Not explicitly stated for the "performance data that describes the assessment done to verify the CellSearch™ Epithelial Cell Control function." The document mentions the control kit contains "24 single-use bottles of CellSearch™ Epithelial Cell Controls," which might hint at the scale of testing or how the product is packaged, but not directly the sample size of a specific test set.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

Not applicable. This device is a control kit for an assay, not an AI/image-based diagnostic requiring expert interpretation for ground truth establishment. The ground truth for this device would be its known cell concentrations.

4. Adjudication Method for the Test Set

Not applicable. As a quality control kit, the "ground truth" is the known concentration of cells spiked into the control.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No. This is a quality control kit, not a diagnostic device requiring human reader interpretation or assistance.

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

Not directly applicable in the context of an "algorithm." The control kit itself, when run through the CellTracks® AutoPrep System and CellSpotter® Analyzer, is evaluating the performance of that system and its associated reagents and detection/identification components. The study assessed the control's function in verifying the system's performance.

7. The type of ground truth used

The ground truth used for the control kit itself is the known concentration of fixed cells (SKBR-3) at two specified levels: High (1000 cells/test) and Low (50 cells/test). These are "assayed controls," meaning their expected values are pre-determined.

8. The sample size for the training set

Not applicable. This is a quality control kit with known cell concentrations, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a group of people.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Debra J. Rasmussen Director of Regulatory Affairs Veridex LLC. 1001 US Hwy 202 Raritan, NJ 08869

AN 1 8 2015

K040898 Re:

Trade/Device Name: CellSearch™ Epithelial Cell Control Kit Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: NRS Dated: June 2, 2004 Received: June 3, 2004

Dear Ms. Rasmussen:

This letter corrects our substantially equivalent letter of June 28, 2004 regarding product code. 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).

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Page 2 -

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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert Beckerl

Robert L. Becker, Jr., MB. Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number (if known):	K040898
Device Name:	CellSearch™ Epithelial Cell Control Kit
Indications for Use:	The CellSearch™ Epithelial Cell Control kit is intended for use as an assayed control, when performing the CellSearch™ Epithelial Cell Kit on the CellTracks® AutoPrep System, to ensure that the sample detection and identification systems are working. For in vitro diagnostic use.

ﻤﺨﺘﻠﻔﺔ ﺗﺴﺘﺨﺪﻣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)	K040898
Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

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2.3 510(k) Summary

JUN 2 8 2004

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: ΚΟΥΔΥΥ

Submitter Name, Address, Contact Information 2.3.1

Veridex, LLC A Johnson and Johnson company 1001 US HWY 202 Raritan, New Jersey 08869-0606

Contact Person:	Debra J. Rasmussen
	Director, Regulatory Affairs
	Veridex, LLC
Telephone:	(908) 704-3942
Fax:	(908) 704-3122
Email:	drasmus1@vrxus.jnj.com

Preparation Date 2.3.2

Date 510(k) Summary Prepared: March 31, 2004

Device Name and Device Classification Information 2.3.3

Trade or Proprietary Name:	CellSearch™ Epithelial Cell Control Kit
Common or Usual Name:	Epithelial Cell Control,Hematology Quality Control Materials
Classification Name:	Control, Hematology Quality Control, Mixtures
Product Code:	NRS
Device Classification:	II
Classification Panel:	Hematology and Pathology Devices
Regulation Number:	21CFR 864.8625

2.3.4 Establishment Registration Number Pending.

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Special Controls under 513(b) and 514 2.3.5

No Special controls have been issued for in vitro devices under sections 513 and 514. Not applicable.

Predicate Device 2.3.6

The CellSearch™ Epithelial Cell Control Kit is substantially equivalent to the Control Cell Kit cleared with the CellSearch Epithelial Cell Kit/Cellspotter 510(k) #K031588.

Device Description 2.3.7

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The standard deviation is that which is anticipated for single determinations of the epithelial cell controls at the two levels (high and low) in a number of different laboratories using different reagent batches.

Device Intended Use 2.3.8

The CellSearch™ Epithelial Cell Control kit is intended for use as an assayed control, when performing the CellSearch™Epithelial Cell Kit assay on the CellSpotter® Analyzer/CellTracks® AutoPrep System, to ensure that the sample detection and identification systems are working.

Summary Comparison to Predicate Device 2.3.9

The CellSearch™ Epithelial Cell Control Kit is substantially equivalent to the Control Cell Kit cleared with the CellSearch Epithelial Cell Kit/Cellspotter 510(k) #K031588 and does not raise any new questions regarding safety and effectiveness.

Table 2.1 lists the characteristics of the CellSearch™ Epithelial Cell Control Kit (new device) and the Control Cell Kit (predicate device).

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Table 2.1. Summary Comparison of New Device and Predicate Device
DeviceCharacteristic	CellSearch™ Epithelial CellControl Kit(New device)	Control Cell Kit(Predicate device)
Intended use	The CellSearch™ Epithelial CellControl kit is intended for use as anassayed control, when performing theCellSearch™ Epithelial Cell Kit onthe CellSpotter®Analyzer/CellTracks® AutoPrepSystem, to ensure that the sampledetection and identification systemsare working.	The Control Cell kit is for useas an assay control, whenperforming the CellSearch™assay, to ensure that thesample detection andidentification systems areworking.
Cells	Breast cancer cell line (SKBr-3)	Same
Fixative	Paraformaldehyde	Same
Matrix of controls	Histopaque 1083, 5% Bovine SerumAlbumin, 0.1% sodium azide	Phosphate Buffered Saline,5% Bovine Serum Albumin,0.1% sodium azide
Control Cell Levels;Expected Targetvalues	Two populations of cells; High (1000cells/test); Low (50 cells/test)	One (high) cell population,1000 cells/test
Dyes used to pre-label cells	DiOC16(3) for high control cellpopulation; DiIC18(5) for lowcontrol cell population.	DiOC16(3) for high controlcell population.
Tests/vial	Unit dose (one test/vial); 24 tests perkit	10 tests/vial; 10 tests per kit

Note: On Table 2.1 the differences are bolded.

2.3.10 Summary of Assessment of Performance Data

Data are presented that demonstrate the use of the controls to assess the performance of the CellSearch™ Epithelial Cell Kit using the CellSpotter® Analyzer and CellTracks® AutoPrep System when detecting and enumerating circulating tumor cells (CTC) in whole blood. Included in this 510(k) submission is the performance data that describes the assessment done to verify the CellSearch™ Epithelial Cell Control function, demonstration that the Control Matrix is substantially equivalent to whole blood for the CellSearch Assay, and has acceptable precision. The assay results support that the controls can monitor that assay performance is working.

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.