XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)

Device Description

XN CAL 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.

AI/ML Overview

The medical device in question is the XN CAL, a calibrator for cell indices used with Sysmex XN series analyzers. The provided text, a 510(k) summary, describes its intended use, comparison to a predicate device, and results of performance testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it describes general study objectives and conclusions about reproducibility and stability. The "reported device performance" is given as conclusions derived from tests.

Parameter/Study	Acceptance Criteria (Implicit)	Reported Device Performance
Multi-Site Precision	Not explicitly stated, but implies meeting reproducibility standards.	"The resultant data set established that XN CAL is safe and effective for its intended use..." and "Study results show XN CAL to be consistently reproducible..."
Single-Site Precision	Not explicitly stated, but implies meeting reproducibility standards.	"The resultant data set established that XN CAL is safe and effective for its intended use..." and "Study results show XN CAL to be consistently reproducible..."
Open-Vial Stability	Not explicitly stated as a numerical target, but expected to demonstrate stability for the claimed duration.	4 hours (Claimed and supported by data)
Closed-Vial Stability	Not explicitly stated as a numerical target, but expected to demonstrate stability for the claimed duration.	35 days (Claimed and supported by data)
Overall Performance	Demonstrates safety, effectiveness, substantial equivalence, and fulfillment of intended use.	"XN CAL is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use." and "substantially equivalent to the products..."

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

The document does not specify the exact sample sizes (number of measurements, number of vials, etc.) used for the multi-site precision, single-site precision, open-vial stability, or closed-vial stability studies.

The data provenance is not explicitly stated regarding country of origin. The studies are described as "Multi-Site" and "Single-Site," suggesting they were conducted at different locations. The studies were likely prospective as they were conducted to substantiate product performance claims for the 510(k) submission.

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

This information is not provided in the document. As XN CAL is a calibrator for automated hematology analyzers, "ground truth" would typically refer to the accurately assigned values for the calibrator, which are then used to calibrate the analyzers. This process usually involves highly controlled laboratory methods rather than expert human interpretation in the way, for example, a radiograph would be interpreted.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of medical images or data is involved and discrepancies need to be resolved. For a calibrator, performance is measured objectively against established reference values or reproducible results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI), not for a laboratory calibrator.

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

This question is not directly applicable in the context of XN CAL as it is a physical calibrator solution, not an algorithm. Its performance is evaluated based on its measured values and stability when run on the specified analyzers, which are themselves automated devices. The "algorithm" here would be the instrument's measurement algorithm, and the calibrator helps ensure that algorithm produces accurate results.

7. The Type of Ground Truth Used

The concept of "ground truth" for a calibrator usually refers to the assigned or reference values for the parameters (WBC, RBC, HGB, HCT, PLT, RET) within the calibrator. These values are established through rigorous, highly accurate, and often multi-replicate testing using reference methods or predicate devices, ensuring their accuracy. The document implies that the "intended use" and "consistently reproducible" nature suggest these established values serve as the ground truth.

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this device. The XN CAL is a physical calibration material, not a machine learning or AI algorithm that requires a "training set" of data. The performance studies described (precision, stability) are a form of verification/validation, not model training.

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

This information is not applicable as there is no "training set" in the context of this 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: K160585

Trade/Device Name: XN CAL Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX 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

510(k) Number (if known)

Device Name XN CAL

Indications for Use (Describe)

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)

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:	Deborah Kipp, Regulatory Affairs Manager7002 South 109th Street; La Vista, NE 68128402-537-5215
Fax:	402-537-5317
Date Prepared:	Revised: October 17, 2016
Names

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

XN CAL™ Assayed Hematology Calibrator Calibrator for Cell Indices (864.8150) KRX Hematology

Predicate Device:

XN CAL™ (K141962)

Intended Use:

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (103/pL), RBC (10°/µL), HGB (g/dL), HCT (%), PLT (103/ µL), and RET (%)

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Description:

Per the FDA guidance document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)), a predicate device was selected in order to demonstrate substantial equivalence for XN CAL. The comparison to the "Comparison to Predicate Device" section.

Comparison to Predicate Device

	XN CAL™ (K141962)-Predicate Device	XN CAL™- Candidate Device	Same or Differences
IntendedUseStatement	XN CAL is used for the calibration andcalibration verification of SysmexXN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parametersinclude:WBC ( $10^3$ /µL), RBC ( $10^6$ /µL),HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), andRET (%)	XN CAL is used for the calibration andcalibration verification of SysmexXN series (XN-10, XN-11, XN-20, XN-21,XN-L) analyzers. Assayed parametersinclude:WBC ( $10^3$ /μL), RBC ( $10^6$ /μL),HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), andRET (%)	Addition of the XN-LAnalyzers.
Open VialStability	4 hours	4 hours	Same
Closed VialStability	49 days	35 days	Closed vial stability now35 days.
Reagents	XN CAL contains the following: stabilizedred blood cell component(s), stabilizedwhite blood cell component(s), stabilizedplatelet component(s), and stabilizednucleated red blood cell component(s) ina preservative medium.	XN CAL contains the following: stabilized redblood 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 CAL, 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 CAL 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 CAL to be consistently reproducible, substantially equivalent to the products, and stable for the entire product dating. XN CAL is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.

Regulation Number and Section

§ 864.8150 Calibrator for cell indices.

(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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.