(189 days)
Not Found
No
The device is a blood collection tube with a preservative, not a software or analytical tool. The description focuses on the chemical composition and physical properties of the tube for sample preservation and collection.
No
The device is described as a blood collection tube intended for storing blood specimens for laboratory analysis (immunophenotyping of WBC by flow-cytometry), not for treating or diagnosing a medical condition in a patient.
No
This device is a blood collection tube intended for the collection and storage of blood specimens for immunophenotyping, not for performing immunophenotyping itself or diagnosing.
No
The device description clearly states it is a "standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative," which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry." This process is performed in vitro (outside the body) to analyze components of the blood.
- Device Description: It's a blood collection tube containing an anticoagulant and preservative, designed to collect blood for laboratory analysis.
- Performance Studies: The description of the performance studies details the analysis of blood samples using flow cytometry, which is a common in vitro diagnostic technique.
The device is a tool used in the process of performing an in vitro diagnostic test (immunophenotyping of WBC by flow-cytometry).
N/A
Intended Use / Indications for Use
Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.
Mentions image processing
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Flow cytometric data for lymphocyte subset cell-surface markers was obtained by analysis of peripheral blood samples collected from multiple healthy donors. A separate clinical study was set up in which samples from HIV positive patients were collected and analyzed. Samples were collected in both K.EDTA blood collection tubes and Cyto-Chex BCT tubes. Testing was performed over a period of 7 days using both Becton-Dickinson FACSCalibur and Beckman Coulter EPICS XL flow cytometers. Results were compared to those from fresh samples (6 hours after draw in K.EDTA). Testing was also performed to establish stability of Cyto-Chex BCT reagent and to verify that under filling the tube would not compromise results.
The Cyto-Chex BCT tube contains a stable composition allowing the un-used tubes to be stored for at least one year at room temperature.
Bland Altman Plots, Light Scatter Dot Plots, and Correlation Coefficient results demonstrate that Cyto-Chex BCT tubes can be effectively used to collect and store clinical specimens for flow-cytometry analysis of Lymphocyte subsets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Immunicon CellSave™, K030596
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories | JUL 27 2004 |
|---|---|---|
| 7002 South 109th Street | ||
| La Vista, NE 68128 |
Official Correspondent: Carol Thompson, Quality Assurance Manager (402) 537-5313
January 19, 2004 Date Prepared:
Names of Device:
| Trade Name: | Cyto-Chex® BCT |
|---|---|
| Common Name: | Blood specimen collection device |
| Classification Name: | Blood specimen collection device, 21CFR862.1675 |
Immunicon CellSave™, K030596 Predicate Device:
Description:
Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.
Intended Use:
Cyto-Chex BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7-day period following collection.
Comparison with Predicate Device:
CellSave tube is for collection and storage of specimens intended to be used for monitoring circulating epithelial (tumor) cells. It is also claimed to be applicable for monitoring T lymphocyte subsets in HIV positive patient management. The components of CellSave and Cyto-Chex BCT are similar.
Testing Performed:
Flow cytometric data for lymphocyte subset cell-surface markers was obtained by analysis of peripheral blood samples collected from multiple healthy donors. A separate clinical study was set up in which samples from HIV positive patients were collected and analyzed. Samples were collected in both K.EDTA blood collection tubes and Cyto-Chex BCT tubes. Testing was performed over a period of 7 days using both Becton-Dickinson FACSCalibur and Beckman Coulter EPICS XL flow cytometers. Results were compared to those from fresh samples (6 hours after draw in K.EDTA). Testing was also performed to establish stability of Cyto-Chex BCT reagent and to verify that under filling the tube would not compromise results.
Conclusions Drawn from the Tests:
The Cyto-Chex BCT tube contains a stable composition allowing the un-used tubes to be stored for at least one year at room temperature.
Bland Altman Plots, Light Scatter Dot Plots, and Correlation Coefficient results demonstrate that Cyto-Chex BCT tubes can be effectively used to collect and store clinical specimens for flow-cytometry analysis of Lymphocyte subsets.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird symbol.
JUL 27 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kerrie Oetter Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th St. LA Vista, NE 68128
Re: K040107 Trade/Device Name: Cyto- Chex ® BCT Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: June 24, 2004 Received: June 29 2004
Dear Ms. Oetter:
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 Iegally 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). 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.
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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 L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. 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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Page _ 1 _ of _ 1_
510(k) Number (if known): K040107
Device Name: _ Cyto-Chex® BCT ________________________________________________________________________________________________________________________________________________
Indications For Use:
Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.
(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) | K040107 |
OR
Prescription Use__X (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)