CD-CHEX CD 34

K993126 · Streck Laboratories, Inc. · GGL · Nov 26, 1999 · Hematology

Device Facts

• Record ID: K993126
• Device Name: CD-CHEX CD 34
• Applicant: Streck Laboratories, Inc.
• Product Code: GGL · Hematology
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CD Chex CD 34 is designed as a control sample for evaluating the binding of monoclonal antibody using flow cytometry. It is intended to be used with Becton Dickinson ProCount Progenitor Cell enumeration kit and with systems using ISHAGE protocol for CD 34 stem cell marker.

Device Story

CD Chex CD 34 is a stabilized suspension of human placental blood containing red and white blood cells; packaged in 1 ml glass vials with polypropylene screw caps. Used as a procedural control in clinical laboratories to monitor monoclonal antibody binding during flow cytometry. Operators (laboratory technicians) use the control to validate CD 34 stem cell enumeration results when utilizing the Becton Dickinson ProCount Progenitor Cell Enumeration Kit or the ISHAGE protocol. The device provides a known reference point to ensure instrument and reagent performance, allowing for accurate clinical decision-making regarding stem cell analysis.

Clinical Evidence

Bench testing only. Studies on three pilot lots assessed long-term stability, open-vial stability, and within-run/site-to-site reproducibility. Results verified the product performed to specifications as a control material for CD 34 measurement procedures.

Technological Characteristics

Stabilized suspension of human placental blood; red and white blood cells; 1 ml glass vials; polypropylene screw caps. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in clinical laboratories performing quantitative stem cell analysis as a control specimen to verify the measurement process for CD 34 positive stem cells in flow cytometry.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• CD Chex Plus RBC (K960894)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck Laboratories, Inc<br>P.O. Box 45625<br>Omaha, Nebraska 68145 |
|----------------------|---------------------------------------------------------------------|
| Correspondent: | Hal Sornson<br>R&D Manager |
| Date Prepared: | September 16, 1999 |
| Names of Device: | CD Chex CD 34 |
| Trade Name: | CD Chex CD 34 |
| Common Name: | Immunophenotyping Control |
| Classification Name: | White Cell Control §864.8625 |
| Predicate Device: | CD Chex Plus RBC (K960894) manufactured<br>by Streck Laboratories |

Description: CD Chex CD 34 is a stabilized suspension of human placental blood
containing red blood cells and white blood cells. It is packaged in glass
vials containing 1 ml of product. Closures are polyproplylene screw
caps. The package contains two vials of a single concentration and an
assay sheet stating the expected values.

Intended Use: CD Chex CD 34 is designed as a control sample for evaluating
the binding of monoclonal antibody using flow cytometry. It is intended
to be used with Becton Dickinson ProCount Progenitor Cell enumeration
kit and with systems using ISHAGE protocol for CD 34 stem cell marker.

Comparison with Predicate Device: CD Chex Plus RBC is a an immunophenotyping
control for several clinically useful cell surface markers. CD Chex CD 34
is assayed only for the CD 34 marker. They are both procedural controls
for monitoring reagents and the instrument.

Discussion of Tests and Test Results: Studies were conducted on three(3) Pilot lots
to assess the performance of CD Chex CD 34. These were:
1.) Long term stability, 2) Open vial stability, 3) Within-run and Site to
Site reproducibility.
The studies verified that the product performed to specifications and is
useful as a control material for CD 34 measurement procedures.

Conclusions Drawn from Tests: CD Chex CD 34 is an effective control for CD 34
immunophenotyping when used according to instructions in the package
insert. Extensive raw material testing assures the user of a safe product.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 1999

Mr. Hal Sornson R & D Manager Streck Laboratories, Inc. 14124 Industrial Road Omaha, Nebraska 68144

Re: K993126 Trade Name: CD-Chex CD 34 Regulatory Class: II Product Code: GGL Dated: September 16, 1999 Received: September 20, 1999

Dear Mr. Sornson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number ( if known): K993126

Device Name:_CD-Chex CD 34

Indications for Use:

A clinical laboratory performing quantitative stem cell analysis needs a control specimen for verifying the measurement process. CD Chex CD 34 is such a specimen. It consists of stabilized placental blood containing a population of CD 34 positive stem cells. It is used as a procedural control for monitoring monoclonal antibody binding in flow cytometry methods. Users of Becton Dickinson ProCount Progenitor Cell Enumeration Kit or ISHAGE protocol can validate their CD 34 results by controlling the procedure with CD Chex CD 34.

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices `K993126`
510(k) Number

Prescription Use V (Per 21CFR 801.109)

OR

Over-The-Counter Use (Optional format 1-2-96)

់

Sep. 24, 1999

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