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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Cyto-Chex® BCT device, which is a blood specimen collection device. It describes the device, its intended use, comparison with a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not explicitly state acceptance criteria in a quantitative manner or present a table of acceptance criteria versus reported device performance.

Instead, the submission focuses on demonstrating that the Cyto-Chex BCT performs comparably to fresh samples collected in K.EDTA tubes for immunophenotyping of WBCs by flow cytometry, specifically for lymphocyte subset cell markers of the HIV panel over a 7-day period. The conclusions drawn are qualitative or based on statistical analysis methods like Bland-Altman plots and correlation coefficients without providing specific thresholds.

Therefore, many of the requested sections about acceptance criteria and quantitative performance metrics cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.

Here's the breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Information Not Explicitly Stated: The document does not provide a table with specific, quantitative acceptance criteria (e.g., "recovery of X% of cell markers" or "correlation coefficient > Y") and then list the device's performance against those criteria. The conclusions are generally qualitative or indicate a comparison to fresh samples.

Summary of Reported Performance (Qualitative based on text):

Stability of Reagent: Unused Cyto-Chex BCT tubes can be stored for at least one year at room temperature.
Immunophenotyping Performance: 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. This performance is implied to be comparable to fresh samples (6 hours after draw in K.EDTA) over a 7-day period.
Underfilling Impact: Testing verified that underfilling the tube would not compromise results (no specific details provided on the extent of underfilling tested or the results).

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Healthy Donors: "multiple healthy donors" (exact number not specified).
- HIV Positive Patients: "samples from HIV positive patients" (exact number not specified).
Data Provenance: The country of origin is not specified. The study involved collecting peripheral blood samples, which implies a prospective collection for the study purpose.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Information Not Stated: The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on flow cytometric analysis of fresh samples collected in K.EDTA tubes as the comparative 'gold standard'.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Stated: Adjudication methods are not described.

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

Not Applicable/Information Not Stated: This device is a blood specimen collection tube, not an AI-powered diagnostic imaging or analysis tool that would involve "human readers" in the context of MRMC studies. Therefore, an MRMC comparative effectiveness study regarding human readers improving with/without AI assistance is not relevant or described.

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

Not Applicable: This device is a physical specimen collection tube, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The ground truth or reference standard for comparison was "fresh samples (6 hours after draw in K.EDTA)". This indicates a comparison to the established method for immediate processing of blood samples for flow cytometry.

8. The sample size for the training set

Not Applicable: This device is a physical medical device (blood collection tube) and does not involve a "training set" in the context of machine learning.

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

Not Applicable: As above, there is no training set for this type of device.

Summary

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510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck Laboratories	JUL 27 2004
	7002 South 109th StreetLa 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:

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.

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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:

(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

Prescription Use__X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.