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

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/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)

*Not Available on the XN-L.

Device Description

XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(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 pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

AI/ML Overview

The provided text is a 510(k) Summary for the XN CHECK™ hematology quality control mixture. It details the device's intended use, comparison to a predicate device, and conclusions from tests. However, it does not fully elaborate on the detailed acceptance criteria for each claimed parameter or explicitly describe the "study that proves the device meets the acceptance criteria" in terms of specific statistical analyses, sample sizes for test sets with ground truth, expert qualifications, or multi-reader studies.

Therefore, many of the requested details cannot be extracted directly from this document. The information provided is at a high level, focusing on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "XN CHECK is used for control and calibration verification... and that the product is stable for the entire product dating." It also mentions "reproducible" and "stable" in the conclusions. However, it does not provide specific numerical acceptance criteria (e.g., maximum allowable coefficient of variation for precision, or specific stability limits for each parameter) nor quantified performance data for each of the numerous assayed parameters. It only describes the types of studies conducted.

Parameter Category	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Implied as met, but not quantified)
Precision	(e.g., CV% < X% for each parameter)	"Consistently reproducible"
Open-Vial Stability	(e.g., % deviation from initial value within Y% for Z days)	"Stable for the entire product dating."
Closed-Vial Stability	(e.g., % deviation from initial value within Y% for Z days)	"Stable for the entire product dating."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "Multi-Site Precision Study" and "Single-Site Precision Study," implying multiple samples were tested, but the exact number of control vials or measurements is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by Streck, Inc.
Retrospective or Prospective: Not explicitly stated, but clinical validation studies for a device like this are typically prospective for stability and precision.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a hematology quality control mixture, not an AI/imaging device requiring expert interpretation for ground truth. Therefore, this question is not applicable in the context of this document. The "ground truth" for a control material would typically be the reference values established by the manufacturer using reference methods and calibrated instruments, not expert consensus on images.

4. Adjudication method for the test set:

Not applicable as this is a quality control mixture and not an interpretive device.

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 as this is a quality control mixture, not an AI-assisted diagnostic device.

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

Not applicable as this is a quality control mixture, not an algorithm. Performance assessment would be based on instrument measurement against established target values.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a hematology quality control mixture, the "ground truth" (or reference values) would be established through a rigorous process of assaying the control material on validated reference instruments using established methodologies. This is typically done by the manufacturer's skilled laboratory personnel, using calibrated equipment, and adhering to strict quality control protocols. It is not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The sample size for the training set:

Not applicable. This device is a quality control material, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, this device does not use a training set in the context of machine learning.

Summary of Missing Information:

The document provides a regulatory summary demonstrating substantial equivalence for a quality control device. It does not contain the detailed study protocols, specific acceptance criteria values, quantified performance results (precision, stability range for each parameter), or detailed method of "ground truth" establishment (beyond implying standard laboratory practices) that would typically be found in a full scientific validation report. The questions about experts, adjudication, MRMC, and standalone AI performance are not relevant to 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 22, 2016

Streck, Inc. Ms. Deborah Kipp Regulatory Affairs Manager 7002 South 109th Street La Vista, NE 68128

Re: K160590

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 18, 2016 Received: October 20, 2016

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

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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.

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/Medical Devices/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 /Industrv/default.htm.

Sincerely,

Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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) K160590

Device Name XN CHECK

Indications for Use (Describe)

*Not Available on the XN-L.

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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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 68128402-537-5215402-537-5317Revised October 17, 2016
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™ (K141964)

Intended Use:

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

*Not Available on the XN-L.

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Description:

Comparison to Predicate Device:

	XN-CHECK (K141964) - PredicateDevice	XN CHECK™- Candidate Device	Same or Differences
IntendedUseStatement	XN CHECK is used for control and calibrationverification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not,however, intended for actual calibration ofthese analyzers. Assayed parametersinclude: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(%), IPF #( $10^3/µL$ ) RET#( $10^6/µL$ ), RET%, IRF%, RET-HE(pg), NRBC#( $10^3/µL$ ),NRBC% (/100 WBC)	XN CHECK is used for control and calibrationverification of Sysmex XN series (XN-10, XN-11,XN-20, XN-21, XN-L) analyzers. It is not,however, intended for actual calibration of theseanalyzers. 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(%), IPF#* ( $10^3/µL$ ),RET#( $10^6/µL$ ), RET%, IRF%, RET-HE(pg),NRBC#* ( $10^3/µL$ ), NRBC%* (/100 WBC)*Not Available on the XN-L.	Addition of XN-L AnalyzerRemoval of the followingparameters on XN-Linstrument:PLT-F( $10^3/μL$ )IPF(%)IPF# ( $10^3/μL$ )NRBC# ( $10^3/µL$ )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: Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability. 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 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.