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

RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/μL), IPF(%), IPF# (10^3/μL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)

Device Description

XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 ml fill. The vials will be packaged in (4) welled vacuum formed clamshell ontainer with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the XN Check™ device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, it discusses the outcomes of the studies. Based on the "Discussion of Tests and Test Results" and "Conclusions Drawn From Tests" sections, the implied acceptance criteria were related to stability and reproducibility, with the reported performance indicating these criteria were met.

Since no specific numerical thresholds are given, the table below reflects what can be inferred:

Acceptance Criteria (Implied)	Reported Device Performance
Open-Vial Stability: Maintain performance over the stated open-vial period.	Established that XN CHECK is stable for its open-vial period (7 days).
Closed-Vial Stability: Maintain performance over the stated closed-vial period.	Established that XN CHECK is stable for its entire product dating (84 days).
Precision Performance: Demonstrate consistent and reliable results.	Study results show XN CHECK to be consistently reproducible.
Safety and Effectiveness: Be safe and effective for its intended use.	Established that XN CHECK is safe and effective for its intended use.
Substantial Equivalence: Performance comparable to the predicate device.	Study results show XN CHECK to be substantially equivalent to the predicate products.
Fulfillment of Intended Use: Perform as described in the Indications for Use.	The product fulfills its intended use 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 for any of the studies (Open-Vial Stability, Closed-Vial Stability, and Precision Performance).

The data provenance is not explicitly stated in terms of country of origin. However, the product is being submitted for FDA approval in the USA, implying studies were conducted to support this market. The studies are described as prospective in nature, as they are performed to "substantiate the product performance claims" for the device being submitted.

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

The document does not mention the use of experts to establish ground truth for the test set. Given that XN CHECK is a hematology quality control mixture, the "ground truth" would likely be established through predefined assay values and analytical methods, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, as it does not involve expert review or interpretation that would typically require adjudication. The performance evaluation is based on analytical measurements against expected values for the control material.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, or at least not described in this document. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. XN CHECK is a quality control material, not a diagnostic device involving human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was implicitly done. The studies mentioned (Open-Vial Stability, Closed-Vial Stability, and Precision Performance) relate to the intrinsic performance of the XN CHECK control material itself when analyzed by the Sysmex XN series analyzers. There is no human-in-the-loop component for the function of the control material.

7. Type of Ground Truth Used

The ground truth for this type of device (a quality control mixture) would be the assigned target values and acceptable ranges for each hematology parameter. These values are typically established through rigorous analytical testing and cross-validation against reference methods or previously validated control materials. The document implies these established analytical expectations as the basis for evaluating "reproducibility" and "stability."

8. Sample Size for the Training Set

The document does not specify a training set sample size. For a quality control material, the concept of a "training set" as understood in machine learning (where algorithms learn from data) does not directly apply. The manufacturing and validation process would involve extensive analytical testing during development and manufacturing, but this is not typically referred to as a "training set."

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

As explained above, a "training set" in the context of machine learning is not applicable here. For the XN CHECK, the "ground truth" (i.e., the expected values and acceptable ranges for performance) would be established by:

Manufacturing specifications: Parameters are designed to fall within specific ranges.
Analytical testing: Extensive in-house testing under controlled conditions to determine the mean and standard deviation for each parameter.
Methodology: Following established laboratory practices and potentially using reference instruments or methods.
Comparison to predicate: Ensuring the new control material performs comparably to the previously accepted predicate (XN CHECK K120742).

In summary, the provided document focuses on the regulatory submission for a hematology quality control product. As such, the studies described are analytical performance studies (stability, precision) rather than diagnostic efficacy studies and therefore many of the requested elements (like experts, adjudication, MRMC, training sets for algorithms) are not directly relevant or discussed.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and professional, reflecting the department's role in promoting public health and well-being.

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 MANGER 7002 SOUTH 109TH STREET OMAHA, NE 68128

Re: K141964

Trade/Device Name: XN CHECK TM Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 27, 2014 Received: October 28, 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

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)

K141964

Device Name XN CHECK

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:Address:Phone:Fax:Date Prepared:	Deborah Kipp, Regulatory Affairs Manager7002 South 109th Street; La Vista, NE 68128402-537-5215402-537-5317July 9, 2014
Names

Trade Name: Common Name: Classification Name: Product Code: Panel:

XN CHECK™ Assayed Hematology Control Hematology quality control mixture (864.8625) JPK Hematology

Predicate Device:

XN CHECK™ (K120742)

Intended Use:

XN CHECK 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:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(10"/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10")pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10%pL), LYMPH#(103/pL), MONO# (10%pL), EO#(10%pL), BASO#(103pL), IG#(103)µL), IPF(%), IPF# (109µL), RET#(109pL), RET%, IRF%, RET-HE(gg), NRBC#(10³/µL), NRBC% (/100 WBC)

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Description:

Comparison to Predicate Device:

	XN-CHECK (K120742)-PredicateDevice	XN CHECK™-Candidate Device	Same or Differences
IntendedUseStatement	XN CHECK 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:	XN CHECK 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:	Addition of the XN-11 andXN-21 analyzers.Addition of an assayedparameter, IPF# (10³/µL)
	RBC(10⁶µL), HGB(g/dL), HCT(%),MCV(fL), MCH(pg), MCHC(g/dL),PLT(10³/μL), PLT-F(10³/μL), RDW-SD(fL), RDW-CV(%), MPV(fL),WBC(10³/μL), NEUT(%), LYMPH (%),MONO(%), EO(%), BASO(%), IG(%),NEUT#(10³/µL), LYMPH#(10³/µL),MONO#(10³/μL), EO#(10³/μL),BASO#(10³/μL), IG#(10³/µL), IPF(%),RET#(10⁶/µL), RET%, IRF%, RET-HE(pg), NRBC#(10³/μL),NRBC% (/100 WBC)	RBC(10⁶/µL), HGB(g/dL), HCT(%), MCV(fL),MCH(pg), MCHC(g/dL), PLT(10³/µL),PLT-F(10³/μL), RDW-SD(fL), RDW-CV(%),MPV(fL), WBC(10³/µL), NEUT(%), LYMPH(%), MONO(%), EO(%), BASO(%), IG(%),NEUT#(10³/µL), LYMPH#(10³/µL),MONO#(10³/µL), EO#(10³/µL),BASO#(10³/μL), IG#(10³/µL), IPF(%), IPF #(10³/µL) RET#(10⁶/µL), RET%, IRF%, RET-HE(pg), NRBC#(10³/μL),NRBC% (/100 WBC)
Open VialStability	7 days	7 days	Same
Closed VialStability	84 days	84 days	Same
Reagents	XN CHECK contains the following:stabilized red blood cell component(s),stabilized white blood cell component(s),stabilized platelet component(s), andstabilized nucleated red blood cellcomponent(s) in a preservative medium.	XN CHECK contains the following: stabilizedred blood cell component(s), stabilized whiteblood cell component(s), stabilized plateletcomponent(s), and stabilized nucleated redblood cell component(s) in a preservativemedium.	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, 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 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 to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK 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.