XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).

Device Description

XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias 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 document is a 510(k) premarket notification for a medical device called "XN-L CHECK™", a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, study details, or results in the format requested.

The document broadly states:

"The resultant data set established that XN-L CHECK is safe and effective for its intended use and that the product is stable for the entire product dating."
"Study results show XN-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."

It mentions the following types of studies were conducted:

Multi-Site Precision Study
Single-Site Precision Study
Open-Vial Stability
Closed-Vial Stability

However, it does not provide any quantitative acceptance criteria or the reported device performance measurements for these studies. Therefore, I cannot generate the requested table or answer most of the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.

Based on the information available, here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that performance data was collected and the device was found safe, effective, and stable, but it does not specify the numerical acceptance criteria (e.g., specific thresholds for precision or stability over time) or the actual reported performance values.

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

Cannot be provided. The document mentions "Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability" but does not specify the sample sizes (number of samples, runs, instruments, or sites) used for these studies, nor the provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable / Cannot be provided. This device is a quality control mixture and not an interpretive AI device that would require expert adjudication for a diagnostic ground truth. The "ground truth" for a quality control device typically involves reference methods or established performance specifications of the analyzer it controls. The document does not mention any experts in the context of establishing ground truth for testing.

4. Adjudication method for the test set

Not applicable / Cannot be provided. As explained in point 3, this is a quality control material, not a diagnostic device requiring expert interpretation and adjudication of results for a reference standard.

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

No. This device is a hematology quality control mixture, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or mentioned.

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

Not applicable / Cannot be provided. This is not an algorithm or AI device. It's a physical control material used to assess the performance of a hematology analyzer.

7. The type of ground truth used

Inferred: For a quality control mixture, the "ground truth" or reference values are typically established through extensive testing against highly accurate reference methods or by comparison to another established quality control material (the predicate device in this case) on the target analyzer. The document doesn't explicitly state the "type of ground truth" but implies it involves demonstrating "consistent reproducibility" and "substantial equivalence to the predicate products."

8. The sample size for the training set

Not applicable / Cannot be provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable / Cannot be provided. As explained in point 8, there's no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.

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 LaVista, NE 68128

Re: K160586

Trade/Device Name: XN-L CHECK™ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 15, 2016 Received: December 16, 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 Part 801); medical device reporting (reporting of medical

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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/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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name XN-L CHECK

Indications for Use (Describe)

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assaved parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/uL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/μL), RET%, IRF%, RET-He (pg).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 19, 2016
Names

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

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

Predicate Device:

XN CHECK™ (K141964)

Intended Use:

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (108/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (103/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (103/μL), NEUT (%), LYMPH (%), MÖNO (%), EÒ (%), BASO (%), ÍG (%), NÉUT# (10°µL), É YMPHÆ (10°µL),
MONO# (10³µL), EO# (10³µL), BASO# (10³µL), IG# (10³µL), RET# (10ºµL), RET%, IRF%, RET-He (pg).

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Description:

Comparison to Predicate Device:

	XN-CHECK (K141964)- Predicate Device	XN-L 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#( $10^3$ /uL),NRBC% (/100 WBC)	XN-L CHECK is used for control andcalibration verification of Sysmex XN-Lanalyzers. It is not, however, intended foractual calibration of this analyzer.Assayed parameters include:RBC ( $10^6$ /µL), HGB (g/dL), HCT (%), MCV(fL), MCH (pg), MCHC (g/dL), PLT( $10^3$ /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), RET# ( $10^6$ /µL),RET%, IRF%, RET-He (pg).	Product is a control forXN-L analyzer.The followingmeasurands are notavailable on XN-LCHECK or the XN-Lanalyzer:IPF(#)IPF(%)NRBC#( $10^3$ /µL)NRBC%(/100WBC)
Open VialStability	7 days	15 days	Increased Open VialStability to 15 days
Closed VialStability	84 days	100 days	Increased Closed VialStability to 100 days
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-L CHECK contains the following:stabilized red blood cell component(s),stabilized white blood cell component(s), andstabilized platelet component(s) in apreservative medium.	Removal of nucleated redblood cell component(s)
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-L 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-L 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-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN-L 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.