(83 days)
No
The device is a control kit containing fixed cells used to verify the performance of an existing system. The description focuses on the composition and function of the control cells themselves, not on any analytical or interpretive capabilities that would typically involve AI/ML. The analysis of the cells is performed by the CellSpotter® Analyzer, which is a separate device mentioned as a reference.
No
The device is described as an "assayed control" used for in vitro diagnostic purposes to ensure systems are working, not to treat a condition.
No
This device is described as an "assayed control" and its purpose is to "ensure that the sample detection and identification systems are working" of the CellSearch™ Epithelial Cell Kit on the CellTracks® AutoPrep System. It is used to verify the performance of other diagnostic systems, not to diagnose a patient directly. Its intended use is "For in vitro diagnostic use," but specifically as a control, not as the diagnostic tool itself.
No
The device is a physical kit containing vials of fixed cells, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Function: The device is intended to be used in vitro (outside the body) to control and verify the performance of another IVD device (the CellSearch™ Epithelial Cell Kit) and associated systems (CellTracks® AutoPrep System and CellSpotter® Analyzer) which are used for detecting and enumerating circulating tumor cells in whole blood. This is a classic function of an IVD control.
- Predicate Device: The predicate device listed (K031588 Control Cell Kit) is also described as being "cleared with the CellSearch Epithelial Cell Kit/Cellspotter," further indicating its role as a control for an IVD system.
N/A
Intended Use / 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.
Product codes
NRS
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.
Mentions image processing
Yes
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
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
2
Indications for Use Statement
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:
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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:
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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
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.
5
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).
6
| Table 2.1. Summary Comparison of New Device and Predicate Device | ||
|---|---|---|
| Device | ||
| Characteristic | CellSearch™ Epithelial Cell | |
| Control Kit | ||
| (New device) | Control Cell Kit | |
| (Predicate device) | ||
| Intended use | The CellSearch™ Epithelial Cell | |
| Control kit is intended for use as an | ||
| assayed control, when performing the | ||
| CellSearch™ Epithelial Cell Kit on | ||
| the CellSpotter® | ||
| Analyzer/CellTracks® AutoPrep | ||
| System, to ensure that the sample | ||
| detection and identification systems | ||
| are working. | The Control Cell kit is for use | |
| as an assay control, when | ||
| performing the CellSearch™ | ||
| assay, to ensure that the | ||
| sample detection and | ||
| identification systems are | ||
| working. | ||
| Cells | Breast cancer cell line (SKBr-3) | Same |
| Fixative | Paraformaldehyde | Same |
| Matrix of controls | Histopaque 1083, 5% Bovine Serum | |
| Albumin, 0.1% sodium azide | Phosphate Buffered Saline, | |
| 5% Bovine Serum Albumin, | ||
| 0.1% sodium azide | ||
| Control Cell Levels; | ||
| Expected Target | ||
| values | Two populations of cells; High (1000 | |
| cells/test); Low (50 cells/test) | One (high) cell population, | |
| 1000 cells/test | ||
| Dyes used to pre- | ||
| label cells | DiOC16(3) for high control cell | |
| population; DiIC18(5) for low | ||
| control cell population. | DiOC16(3) for high control | |
| cell population. | ||
| Tests/vial | Unit dose (one test/vial); 24 tests per | |
| kit | 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.