(67 days)
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.
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.
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.
Below is the requested information regarding the acceptance criteria and study details for the CD Chex CD 34 device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the device performance in a qualitative manner rather than providing specific numerical acceptance criteria and corresponding performance metrics for each criterion. The study aimed to verify the product performed to specifications, but the specifications themselves are not detailed in quantitative terms.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Long term stability | "The studies verified that the product performed to specifications" |
| Open vial stability | "The studies verified that the product performed to specifications" |
| Within-run reproducibility | "The studies verified that the product performed to specifications" |
| Site to Site reproducibility | "The studies verified that the product performed to specifications" |
2. Sample size used for the test set and the data provenance:
- Sample Size: "Studies were conducted on three (3) Pilot lots". The exact number of individual samples (vials) within these lots tested is not specified beyond this.
- Data Provenance: Not explicitly stated, but given it is a product from Streck Laboratories, Inc. in Omaha, Nebraska, and the submission is to the FDA, it is most likely from internal laboratory testing, likely prospective. Country of origin of the data is implicitly the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The device is a control material for evaluating monoclonal antibody binding using flow cytometry, where the "ground truth" would typically be the expected values for the CD 34 marker established by the manufacturer's internal assay and calibration methods, rather than expert consensus on individual patient samples.
4. Adjudication method for the test set:
This information is not applicable/provided. The study focuses on the stability and reproducibility of a control material against its own specifications, not on diagnostic accuracy requiring adjudication of interpretations.
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:
This information is not applicable/provided. The device is an immunophenotyping control used to verify the performance of flow cytometry systems and reagents, not an AI-assisted diagnostic tool for Human-in-the-Loop interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. The device is a control material, not an algorithm. Its performance is evaluated against pre-defined specifications through laboratory testing.
7. The type of ground truth used:
The "ground truth" for this control device is its pre-determined expected values for CD 34 expression, which are established internally by the manufacturer during its assay and calibration processes. The document states, "The package contains two vials of a single concentration and an assay sheet stating the expected values." This implies that the performance was compared against these established expected values.
8. The sample size for the training set:
This information is not applicable/provided. The device is a control material, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable/provided. As above, the device is not an AI/ML algorithm requiring a training set. The "ground truth" for the device's expected performance (its assay values) would be established by the manufacturer's validated internal methods during product development and manufacturing.
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510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, IncP.O. Box 45625Omaha, Nebraska 68145 |
|---|---|
| Correspondent: | Hal SornsonR&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) manufacturedby 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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three interconnected human profiles.
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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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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Image /page/3/Picture/0 description: The image shows a handwritten text string. The string appears to be an identifier or code, possibly related to document management or labeling. The text reads 'K993126/A1' and is written in black ink on a white background.
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](https://510k.innolitics.com/device/K993126)
510(k) Number
Prescription Use V (Per 21CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
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Sep. 24, 1999
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§ 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.