(57 days)
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.
CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.
The provided text describes a 510(k) premarket notification for a medical device called CD-Chex® Plus BC, which is an immunophenotyping control. The information focuses on demonstrating its substantial equivalence to a predicate device, CD-Chex® Plus, and its stability and reproducibility.
However, the submission does not contain the kind of detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. This is because CD-Chex® Plus BC is a quality control specimen, not an AI/ML algorithm. The "device performance" in this context refers to its stability and reproducibility as a control material, not the diagnostic performance of an AI system.
Therefore, many of the requested fields cannot be directly populated from the provided text as they are designed for evaluating AI/ML-based diagnostic devices.
Here's an attempt to answer the questions based on the available information, noting where the information is not applicable or not provided for this type of device:
1. A table of acceptance criteria and the reported device performance
For a quality control specimen like CD-Chex® Plus BC, "acceptance criteria" and "device performance" relate to its ability to remain stable and reproducible over time and across different sites. Specific quantifiable criteria (e.g., allowable ranges for cell counts or antigen expression) are not detailed in this summary but would typically be established by the manufacturer and validated through the studies mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Closed Vial Stability (maintain specified characteristics) | Consistently reproducible and stable for 60 days |
| Open Vial Stability (maintain specified characteristics after opening) | Consistently reproducible and stable for the entire product dating (specific duration not in summary) |
| Reproducibility Across Sites (consistent results at different locations) | Consistently reproducible across sites |
| Substantial Equivalence to Predicate Device (CD-Chex® Plus) | Determined to be substantially equivalent |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The studies involved testing the product over time and at alternate sites, implying multiple samples of the CD-Chex® Plus BC product itself were used.
- Data Provenance: Not specified. The studies were likely conducted by the manufacturer (Streck) and potentially collaborating sites (Alternate Site Testing). It's reasonable to assume the studies were prospective, as they involved monitoring the product's stability and performance over time.
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)
This concept is not directly applicable to a quality control specimen. The "ground truth" for CD-Chex® Plus BC would be its inherent specifications and expected values (e.g., target ranges for cell populations or fluorescence intensities), which are established through the manufacturing process and extensive characterization/validation by the manufacturer's R&D and QA teams. This doesn't involve "experts" in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for a quality control product.
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. MRMC studies are for evaluating the impact of an AI system on human diagnosticians. CD-Chex® Plus BC is a quality control material for flow cytometry instruments, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. CD-Chex® Plus BC is not an algorithm. Its performance is evaluated intrinsically as a biological control material.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for a quality control material is its established specifications and expected performance characteristics, determined by the manufacturer's internal validation processes and scientific principles of cellular stability. It's not based on expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The sample size for the training set
Not applicable. As a quality control specimen, CD-Chex® Plus BC does not have a "training set" in the context of machine learning. The studies listed (Closed Vial Stability, Open Vial Stability, Alternate Site Testing) are validation studies of the manufactured product.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" and associated "ground truth" in the AI/ML sense for this product. The "truth" about the product's functionality (stability and reproducibility) is established through the experimental results of the "Testing Performed" section.
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510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck7002 South 109th StreetLa Vista, NE 68128 |
|---|---|
| Official Correspondent: | Carol Thompson, Quality Assurance Manager(402) 537-5313 |
| Date Prepared: | July 15, 2005 |
| Names of Device:Trade Name: | CD-Chex® Plus BC |
| Common Name: | Immunophenotyping Control |
| Classification Name: | White Cell Control, 21CFR864.8625 |
| Predicate Device: | CD-Chex® Plus (K960894) |
Description: CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.
Intended Use:
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flowcytometric procedures performed with Beckman Coulte® flow cytometry instruments.
Comparison with Predicate Device:
Like CD-Chex Plus, CD-Chex Plus BC 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 Plus, CD-Chex Plus BC has a shorter closed vial stability. CD-Chex Plus BC closed vial stability is 60 days, where CD-Chex Plus is 90 days. The other difference is that CD-Chex Plus BC has two components that are used generally for stabilizing cellular components that are at a higher concentration than CD-Chex Plus. This allows the product to work optimally with Coulter and BC FACSCount flow cytometry systems.
Testing Performed:
Three studies of CD-Chex Plus BC were conducted: 1) Closed Vial Stability; 2) Open Vial Stability; and 3) Alternate Site Testing. Study results showed CD-Chex Plus BC to be consistently reproducible and stable for the entire product dating.
Conclusions Drawn from the Tests:
Study results show CD-Chex Plus BC to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. CD-Chex Plus BC is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Thompson Quality Assurance Manager Streck 7002 South 109th Street La Vista, Nebraska 68128
AUG 1 6 2005
Re: K051633 Trade/Device Name: CD-Chex® Plus BC Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Regulatory Class: II Product Code: GGL Dated: July 21, 2005 Received: July 22, 2005
Dear Ms. Thompson:
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 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) 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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
lobetz Beckerh
Robert L. Becker, Jr., MD, PH.1 Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
K05 No33
CD-Chex® Plus BC Device Name:
Indications For Use:
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Il Reeves for J. Bautista
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051632
§ 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.