(80 days)
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No
The summary describes a control material for flow cytometry and does not mention any AI or ML components in its intended use, device description, or performance studies.
No
The device is described as a control for evaluating monoclonal antibody binding by flow cytometry, providing a reference for normal peripheral blood leukocytes. It is used for analytical purposes in laboratory settings, not for treating or diagnosing patients.
No.
CD-Chex PLUS is a control used for evaluating monoclonal antibody binding by flow cytometry, providing a reference for normal peripheral blood leukocytes. It is not used to diagnose a medical condition in a patient.
No
The device description explicitly states it is a suspension of stabilized human red and white blood cells packaged in glass vials, indicating it is a physical control material, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CD-Chex PLUS is "intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (flow cytometry with monoclonal antibodies).
- Device Description: The device is a "suspension of stablized human red blood cells and human white cells packaged in glass vials." This is a reagent or control material used in laboratory testing.
- Flow Cytometry: The input imaging modality is flow cytometry, which is a common technique used in in vitro diagnostic testing, particularly for analyzing blood cells.
- Performance Studies: The summary of performance studies describes testing related to reproducibility and stability, which are typical evaluations for IVD control materials.
- Predicate Device: The mention of a predicate device (CD-Chex) with a K number indicates that this device is being compared to a previously cleared medical device, which is a common process for IVDs seeking regulatory clearance.
All these factors strongly point to CD-Chex PLUS being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems
Product codes
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Device Description
CD-Chex PLUS is a suspension of stablized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Four studies of CD-Chex PLUS were conducted: () Lot to Lot Reproducibility and Comparison to Whole Blood ; II) Site to Site Reproducibility and Comparison to Predicate Device; III) Long Term Stability; and IV) Open Vial Stability. Study results showed CD-Chex PLUS to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.
14306 Industrial Road
Omaha, Nebraska 68144 | MAY 24 1996 |
|-------------------------|-----------------------------------------------------------------------------------------|-------------|
| Official Correspondent: | Theodore Heise, Ph.D.
Quality Assurance/Regulatory Affairs Manager
(402) 691-7465 | |
| Date Prepared: | May 13, 1996 | |
| Names of Device: | | |
| Trade Name: | CD-Chex PLUS (K960894) | |
| Common Name: | Immunophenotyping control | |
| Classification Name: | White cell control (§864.8625) | |
CD-Chex (K920997) manufactured by Streck Laboratories Predicate Device:
- Description: CD-Chex PLUS is a suspension of stablized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems
- Comparison with Predicate Device: Like CD-Chex PLUS is intended to enable the user to verify satisfactory performance of flow cytometry systems. Both devices contain control cells which possess surface antigens detectable with monoclonal antibodies. Unlike CD-Chex, CD-Chex PLUS contains stabilized human red cells. This allows the user to verify proper performance of the red call lysing step which gives the user a true positive procedural control.
- Discussion of Tests and Test Results: Four studies of CD-Chex PLUS were conducted: () Lot to Lot Reproducibility and Comparison to Whole Blood ; II) Site to Site Reproducibility and Comparison to Predicate Device; III) Long Term Stability; and IV) Open Vial Stability. Study results showed CD-Chex PLUS to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn from Tests: CD-Chex PLUS is a safe and effective control for immunophenotyping when used as instructed in the product package insert.
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MSUNANC
Image /page/1/Figure/4 description: The image shows the packaging for CD-Chex PLUS, an immunology control for cluster designation. The packaging indicates that the product contains human leukocytes and erythrocytes and is for in vitro diagnostic use only. It should be stored between 2° to 10° C and should not be frozen. The packaging also includes the Streck Laboratories, Inc. logo and address: 14306 Industrial Rd. Omaha, NE 68144 USA.
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Image /page/1/Figure/10 description: The image shows a product label for "CD-Chex PLUS" by Streck Laboratories, Inc. The label indicates that the product is an immunology control for cluster designation and contains human leukocytes and erythrocytes. The product volume is 2.5 ml, and the storage instructions advise keeping it between 2 to 10 degrees Celsius and not freezing it.
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