XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not. however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)

Device Description

XN CHECK™ BF is an in-vitro diagnostic product 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 a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are at 2 - 8° C.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called XN CHECK™ BF. This document focuses on the substantial equivalence of the new device to a predicate device, rather than providing a detailed study design with specific acceptance criteria and performance metrics typically found for AI/ML-based medical devices or diagnostic tests.

The XN CHECK™ BF is a hematology quality control mixture for Sysmex XN series analyzers, not an AI-powered diagnostic device. Therefore, many of the questions related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable to this submission.

However, based on the information provided, here's a breakdown of what can be articulated regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with specific thresholds (e.g., "accuracy > 90%"). Instead, the "acceptance criteria" are implied by the nature of a quality control product and its intended use, which is to demonstrate stability, reproducibility, and substantial equivalence to a predicate.

Acceptance Criteria (Implied)	Reported Device Performance and Discussion of Tests
Open-Vial Stability	"product performance data for the following studies: Open-Vial Stability... The resultant data set established that XN CHECK BF is safe and effective for its intended use and that the product is stable for the entire product dating." The stated open-vial stability period is 30 days.
Closed-Vial Stability	"product performance data for the following studies: Closed-Vial Stability... The resultant data set established that XN CHECK BF is safe and effective for its intended use and that the product is stable for the entire product dating." The stated closed-vial stability period is 84 days.
Precision Performance (Reproducibility)	"product performance data for the following studies: ...Precision Performance. The resultant data set established that XN CHECK BF is safe and effective for its intended use and that the product is stable for the entire product dating." "Study results show XN CHECK BF to be consistently reproducible..."
Substantial Equivalence to Predicate	Demonstrated through comparison tables (Intended Use, Open Vial Stability, Closed Vial Stability, Reagents, Storage Conditions) which show mostly "Same" or minor "Differences" (addition of analyzer models) that don't alter fundamental performance. "Study results show XN CHECK BF to be ... substantially equivalent to the predicate products."
Safety and Effectiveness	"The resultant data set established that XN CHECK BF is safe and effective for its intended use..." and "XN CHECK BF is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set in terms of the number of samples or runs for the stability and precision studies. It mentions "product performance data" was collected but does not provide details on the experimental design, number of replicates, or number of lots tested.

Data Provenance: Not explicitly stated, but the studies were conducted by Streck, Inc., implying internal company data.
Retrospective or Prospective: Given the nature of stability and precision studies for a quality control material, they would typically be prospective studies designed and executed specifically for this submission, following predefined protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The device is a hematology quality control mixture, not a diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for a control material would be its manufacturing specifications and the measured values on reference instruments.

4. Adjudication Method for the Test Set

This is not applicable for a quality control product study. Adjudication methods are typically used when subjective interpretations (e.g., image reads) are involved to resolve discrepancies among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving human readers like radiologists) to assess the impact of AI assistance on human performance. The XN CHECK™ BF is a quality control material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone performance study in the context of an "algorithm only" is not applicable. The device itself is a physical quality control material used with an analyzer, not an algorithm. The "performance" refers to the stability and reproducibility of the control material's measured parameters, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for a quality control material like XN CHECK™ BF would be the expected target values and ranges for its assayed parameters, established through a rigorous manufacturing and assay process using reference methods and calibrated instruments. This is analogous to a reference standard, not ground truth derived from pathology, expert consensus, or outcomes data used for diagnostic algorithms.

8. The Sample Size for the Training Set

This is not applicable. The XN CHECK™ BF is a manufactured quality control material, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 5, 2014

STRECK, INC. C/O MS DEBORAH KIPP REGULATORY AFFAIRS MANAGER 7002 SOUTH 109TH STREET LA VISTA, NE 68128

Re: K141957

Trade/Device Name: XN CHECK™ BF Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: October 24, 2014 Received: October 27, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

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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Indications for Use

510(k) Number (if known)

K141957

Device Name XN CHECK BF

Indications for Use (Describe)

WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

510(k) Submitter:	Streck7002 South 109th StreetLa Vista, NE 68128
Official Correspondent:Address:Phone:Fax:Date Prepared:	Deborah Kipp, Regulatory Affairs Manager7002 South 109th Street; La Vista, NE 68128402-537-5215402-537-5317April 18, 2014
Names
Trade Name:	XN CHECKTM BF
Common Name:	Assayed Hematology Control
Classification Name:	Hematology quality control mixture (864.8625
Product Code:	JPK
Panel:	Hematology

Predicate Device:

XN CHECK™ BF (K120744)

Intended Use:

XN CHECK BF is used for control and calibration verification of Sysmex XN-10, XN-11, XN-20 XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10³/µl), RBC-BF (10˚/ µl), MN# (10˚µl), PMN# (10˚µl), MN% (%), PMN% (%),
TC-BF# (10˚µl)

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Description:

	XN-CHECK BF (K120744)-Predicate Device	XN CHECK™ BF -Candidate Device	Same or Differences
Intended UseStatement	XN CHECK BF is used for control andcalibration verification of Sysmex XNseries (XN-10, XN-20) analyzers. It isnot, however, intended for actualcalibration of these analyzers. Assayedparameters include:WBC-BF (10³/µl), RBC-BF (10⁶/µl),MN# (10³/µl), PMN# (10³/µl), MN% (%),PMN% (%), TC-BF# (10³/µl)	XN CHECK BF is used for control andcalibration verification of Sysmex XN series(XN-10, XN-11, XN-20, XN-21) analyzers. Itis not, however, intended for actualcalibration of these analyzers. Assayedparameters include:WBC-BF (10³/µl), RBC-BF (10⁶/ μl), MN#(10³/µl), PMN# (10³/µl), MN% (%), PMN%(%), TC-BF# (10³/µl)	Addition of the XN-11 andXN-21 analyzers.
Open VialStability	30 days	30 days	Same
Closed VialStability	84 days	84 days	Same
Reagents	XN CHECK BF contains the following:stabilized red blood cell component(s)and stabilized white blood cellcomponent(s) in a preservative medium.	XN CHECK BF contains the following:stabilized red blood cell component(s) andstabilized white blood cell component(s) in apreservative medium.	Same
StorageConditions	2 - 8°C	2 - 8°C	Same

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Discussion of Tests and Test Results:

To substantiate the product performance claims for XN CHECK BF, Streck collected product performance data for the following studies: Open-Vial Stability, Closed-Vial Stability, and Precision Performance. The resultant data set established that XN CHECK BF is safe and effective for its intended use and that the product is stable for the entire product dating. The product fulfills its intended use as instructed in the Instructions for Use.

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 instructed in the Instructions for Use.

Regulation Number and Section

§ 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.