(221 days)
XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
WBC-BF (103/μl), RBC-BF (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)
XN CHECK™ BF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.
The provided document is a 510(k) summary for the Streck XN CHECK™ BF device, which is a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device (Cell-Chex Auto-[K053362](https://510k.innolitics.com/search/K053362)). The document also includes information about the tests conducted to establish performance.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
**1. Table of Acceptance Criteria and Reported Device Performance**
The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it makes general statements about the study results. The primary "performance" assessed for this type of device (a quality control mixture) relates to its stability and consistency, and its substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|-----------------------------|------------------------------------------------------------------|----------------------------------------------------------------|
| Open-Vial Stability | Stability for 30 days (matching predicate device) | "Same" as predicate (30 days) |
| Closed-Vial Stability | Stability for at least 75 days (matching predicate device) | 84 days (exceeds predicate's 75 days) |
| Precision Performance | Consistency and reproducibility | "consistently reproducible" |
| Substantial Equivalence | Performance comparable to the predicate device (Cell-Chex Auto) | "substantially equivalent to the predicate product" |
| Safety and Effectiveness | Device is safe and effective for its intended use | "XN CHECK™ BF is a safe and effective product, which fulfills its intended use" |
**2. Sample Size Used for the Test Set and Data Provenance**
The document does not specify the exact sample sizes used for the Open-Vial Stability, Closed-Vial Stability, or Precision Performance tests. It simply states that "The following studies were conducted to establish performance of XN CHECK™ BF."
Data Provenance: Not explicitly stated, but these types of studies for in-vitro diagnostic controls are typically conducted internally by the manufacturer using fresh device samples, often in a laboratory setting. It is not mentioned whether the data is retrospective or prospective, but stability studies inherently involve prospective evaluation over time.
**3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts**
This information is not applicable and therefore not provided in the document. For a hematology quality control mixture, "ground truth" isn't established by human expert consensus on interpretations of images or clinical data. Instead, the "truth" is derived from the established values of the control material, measured on high-precision reference instruments or by defined methods. The stability and precision studies would involve comparing measurements over time and across different runs/lots, rather than expert interpretation.
**4. Adjudication Method for the Test Set**
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human readings or interpretations, typically in studies involving imaging or clinical diagnosis. This device is a quality control material, and its performance is assessed through quantitative laboratory measurements, not through subjective human interpretation requiring adjudication.
**5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance**
Not applicable. This device is an in-vitro diagnostic control, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study and a human-in-the-loop comparison with AI assistance are not relevant to its evaluation.
**6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done**
Not applicable. This device is a physical quality control material for analyzers, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product. Its performance is inherent to its chemical and biological composition and how it performs on specific analyzers.
**7. The Type of Ground Truth Used**
The concept of "ground truth" as typically applied in AI/diagnostic imaging studies (e.g., pathology, clinical outcomes, expert consensus) does not directly apply here. For a quality control material like XN CHECK™ BF, the "ground truth" is established by:
* **Reference Methodology:** The manufacturing process and characterization of the control material itself, which targets specific analyte concentrations (e.g., WBC-BF, RBC-BF counts).
* **Assayed Values:** The expected range of values for each parameter (WBC-BF, RBC-BF, etc.) determined through rigorous testing on reference instruments and methods, often by the manufacturer. These assayed values serve as the "true" or target values against which the control material's performance (stability, precision) is measured when run on user instruments.
* **Comparison to Predicate Device:** Substantial equivalence implies that the performance characteristics (including stability and precision of measurements) are comparable to an already legally marketed and accepted control material, the Cell-Chex™ Auto.
**8. The Sample Size for the Training Set**
Not applicable. This device is not an AI algorithm that requires a "training set" in the conventional machine learning sense. The "training" here would be the manufacturing process and initial characterization of the control material.
**9. How the Ground Truth for the Training Set was Established**
Not applicable, as there is no "training set" in the context of an AI algorithm. The "truth" for this control material is established through its manufacturing specifications and extensive testing to determine its assayed values and stability characteristics, often using validated laboratory methods and reference instruments.
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OCT 1 9 2012
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck7002 South 109th StreetOmaha, NE 68128 |
|---|---|
| ------------------- | ------------------------------------------------------ |
Official Correspondent: Deborah Kipp, Quality Assurance Coordinator (402)537-5215
coordinates
Date Prepared: Revised-September 21, 2012
Name of Device: Trade Name: XN CHECK™ BF Common Name: Assayed Hematology Control Classification Name: Hematology Quality Control Mixture-(JPK-864.8625)
Cell-Chex Auto-K053362
Predicate Device:
Description:
XN CHECK™ BF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.
Intended Use:
XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
WBC-BF (103/μl), RBC-BF (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)
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Comparison to Predicate Device:
| Cell-Chex™ Auto-K053362 | XN CHECK™ BF | |
|---|---|---|
| (Predicate Product) | ||
| Intended UseStatement | Cell-Chex Auto is an assayed wholeblood control for evaluating theaccuracy and precision ofhematology instruments thatmeasure blood cell counts in patientbody fluid samples. | XN CHECK BF is used for control andcalibration verification of SysmexXN series (XN-10, XN-20) analyzers.It is not, however, intended for actualcalibration of these analyzers.Assayed parameters include:WBC-BF (103/µl), RBC-BF (106/ µl),MN# (103/µl), PMN# (103/µl),MN% (%), PMN% (%), TC-BF#(103/µl) |
| Open Vial Stability | 30 days | Same |
| Closed VialStability | 75 days | 84 days |
| Reagents | Cell-Chex™ Auto containsstabilized human red blood cellsand white blood cells in apreservative medium. | XN CHECK BF contains the following:stabilized red blood cell component(s)and stabilized white blood cellcomponent(s) in a preservativemedium. |
| StorageConditions | 2 - 10°C | 2 - 8°C |
Discussion of Tests and Test Results:
The following studies were conducted to establish performance of XN CHECK™ BF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CHECK™ BF is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Study results show XN CHECK™ BF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK™ BF is a safe and effective product, which fulfills its intended use when used as instructions for Use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 19 2012
Streck c/o Ms. Deborah S. Kipp Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
Re: K120744
Trade/Device Name: XN-CHECK™ BF Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: September 28, 2012 Received: October 01, 2012
Dear Ms. Kipp:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Deborah Kipp
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Monai M Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indication for Use Form
510(k) Number (if known): K 1207 44
Device Name: XN CHECK™ BF
Indications For Use:
XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
WBC-BF (103/μl), RBC-BF (108/μl), MN# (10³/μl), PMN# (10³/μl), MN% (%), PMN% (%), TC-BF# (103/μl)
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120744
Page 1 of 1
§ 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.