XN CHECK 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:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)

Device Description

XN CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red 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 Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) for the XN CHECK™. Instead, the performance objective was to be "consistently equivalent and effective" to the predicate product. The studies aimed to demonstrate stability (open and closed vial) and overall performance comparable to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance
Open Vial Stability: Be equivalent to the predicate (7 days).	"All testing showed that were Open Vial Stability...consistent to the predicate product and stable for the shelf life claimed." (Same as predicate: 7 days)
Closed Vial Stability: Be equivalent to the predicate (84 days).	"All testing showed that were ...Closed Vial Stability...consistent to the predicate product and stable for the shelf life claimed." (Same as predicate: 84 days)
Overall Performance: Consistently equivalent and effective to the predicate device.	"Study results show XN CHECK™ to be consistently equivalent and effective...XN CHECK™ is a safe and effective product, which fulfills its intended use when used as instructions for Use."

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

The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It only states that "The following studies were conducted to establish performance of XN CHECK™" and mentions "All testing" for stability. Given the nature of a hematology control product, the "test set" would likely refer to batches of the control material tested against the predicate, rather than patient data.

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

This information is not provided because this type of device (a quality control mixture) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI diagnostic might. The ground truth for a control material is typically established through analytical methods and comparisons to a known standard or predicate device.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The evaluation of a hematology control mixture relies on analytical measurements against established values and comparison to a predicate, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists, pathologists). The XN CHECK™ is a quality control product, not a diagnostic tool that interacts with human readers in that capacity.

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

The XN CHECK™ is a physical control material, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply. Its performance is assessed by how well it maintains its specified parameter values and how consistently it performs across analyzers, similar to a known reference standard.

7. The Type of Ground Truth Used

The ground truth for the XN CHECK™ would be the expected assayed values for each parameter (RBC, HGB, etc.) as determined by the manufacturer, and its performance is evaluated by demonstrating conformance to these expected values and equivalency to the predicate device. The predicate device (e-CHECK (XE)™) itself serves as a reference point for performance comparison.

8. The Sample Size for the Training Set

This product is a physical control material and not an AI algorithm, so the concept of a "training set" in the context of machine learning does not apply. Its manufacturing process and formulation are developed through R&D, and its performance is validated through testing batches of the product, not by training a model on a dataset.

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

Given that this is not an AI algorithm, there is no "training set" or ground truth established in that manner. The "ground truth" for the development of such a control would involve rigorous analytical methods, characterization of its components, and extensive testing to ensure stability and accuracy across different batches and on the target analyzers.

Summary

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510(k) Summary of Safety and Effectiveness

(5742

OCT 1 9 2012 .

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Deborah Kipp, Quality Assurance Coordinator(402)537-5215
Date Prepared:	Revised-September 21, 2012
Name of Device:Trade Name:Common Name:Classification Name:	XN CHECK™Assayed Hematology ControlHematology quality control mixture (JPK-864.8625)
Predicate Device:	e-CHECK (XE)™-K063218
Description:

Intended Use:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONQ(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)

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Comparison to Predicate Device:

: :

	e-CHECK (XE)® -K063218(Predicate Product)	XN CHECK™
IntendedUseStatement	e-CHECK (XE)® is intended to be usedas a control for complete blood cell count(CBC), white blood cell differential,reticulocyte, and nucleated red blood cell(NRBC) parameters on Sysmex XE-Series instruments.	XN CHECK is used for control and calibrationverification of Sysmex XN series (XN-10,XN-20) analyzers. It is not, however, intendedfor actual calibration of these analyzers.Assayed parameters include:RBC( $10^6/μL$ ), HGB(g/dL), HCT(%), MCV(fL),MCH(pg), MCHC(g/dL), PLT( $10^3/μL$ ),PLT-F( $10^3/μL$ ), RDW-SD(fL), RDW-CV(%),MPV(fL), WBC( $10^3/μL$ ), NEUT(%), LYMPH(%), MONO(%), EO(%), BASO(%), IG(%),NEUT#( $10^3/μL$ ), LYMPH#( $10^3/μL$ ), MONO#( $10^3/μL$ ),EO#( $10^3/μL$ ), BASO#( $10^3/μL$ ),IG#( $10^3/μL$ ), IPF(%), RET#( $10^3/μL$ ), RET%,IRF%, RET-HE(pg), NRBC#( $10^3/μL$ ), NRBC%(/100 WBC)
Open VialStability	7 days	Same
ClosedVialStability	84 days.	Same
Reagents	The e-CHECK(XE)® control consists ofstabilized human and animal blood. Thisproduct is provided in three levels thatvary in concentration by parameters.Vials are labeled L1, L2, and L3.	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.
StorageConditions	2 - 8°C	Same

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Discussion of Tests and Test Results:

DIScussion of Tests and Test Nesults.
The following studies were conducted to establish performance of XN CHECK™ and teach of the The following studies were vondation to libre in performance. All testing showed that were Open Phar Stablity, Olosca Vial Stablity, and President to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

Conclusions brawn i ronr rests.
Study results show XN CHECK™ to be consistently consistently equivals and effective Study Tesulis Show XN OFEON - to be re product dating. XN CHECK™ is a safe and effective product, which fulfills its intended use when used as instructions for Use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 19 2012

Streck c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128

Re: K120742

Trade/Device Name: XN-CHECK™ 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 for ass barber 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 I ou may arous 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 If your device is classified (boo are ) Existing major regulations affecting your device can be four di 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 r toase be devices and internination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Or ice 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,

mana in 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): K120742

Device Name: XN CHECK™

Indications For Use:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (1%), MONO(%), EQ(%), BASO(%), IG(%), NEUT#(103)pL), LYMPH#(103/pL), MONO# (10°/μL), MONO®(L), BASO#(10³), 1G#(10³/pL), IPF(%), RET#(10º/pL), RET%, IRF%, RET-HE(pg), NRBC#(103/µL), NRBC% (/100 WBC)

Prescription Use × (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 Diagnostie Device Evaluation and Safety

510(k) K120742

Page 1 of 1

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.