(80 days)
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
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.
The provided 510(k) summary for K960894 (CD-Chex PLUS) does not contain sufficient detail to complete all sections of the request. This device is an immunophenotyping control, not an AI/ML powered device, therefore many of the requested categories (e.g., sample size for test set, expert qualifications, MRMC, training set details) are not applicable or not provided in the context of typical AI/ML device studies.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document speaks generally about "reproducibility" and "stability" as key performance indicators without specifying numerical acceptance criteria for each. The stated device performance is that it met these unspecified criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Lot to Lot Reproducibility | Consistently reproducible |
| Site to Site Reproducibility | Consistently reproducible |
| Long Term Stability | Stable for entire product dating |
| Open Vial Stability | Stable for entire product dating |
| Substantial Equivalence to Predicate Device | Substantially equivalent |
| Verification of red cell lysing step (unique to CD-Chex PLUS) | Satisfactory performance confirmed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Four studies" were conducted but does not specify the sample sizes (e.g., number of lots, number of vials, number of sites) for each study. The data provenance is not specified beyond being generated by "Streck Laboratories, Inc."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for ground truth establishment. Its performance is evaluated based on its own inherent stability and reproducibility properties when analyzed by flow cytometry systems.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as ground truth by expert consensus is not relevant for this type of device.
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. This is not an AI-powered device, and no human reader effectiveness study would be performed for a laboratory control.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its performance is evaluated through laboratory studies on its physical characteristics and behavior in flow cytometry systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI devices (e.g., pathology, clinical outcome) is not directly applicable here. For a control material like CD-Chex PLUS, the "truth" is established by its intrinsic and consistent characteristics (antigen expression, cell count, viability) when measured by a flow cytometer, and its ability to provide a predictable reference. The performance is assessed against expected values or by comparison to a predicate device, rather than against an independent clinical "ground truth."
8. The sample size for the training set
Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a control material, not an AI/ML algorithm that requires a training set.
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510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.14306 Industrial RoadOmaha, 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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TALLAN Corporation Antonomia Participante de Ousse.
Microsoft on Provinsion Some Comments of More Comments Comments
Microsoft of Concerner Comments of Ministration
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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§ 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.