XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include: PLT-F (10^3/ uL)

Device Description

XN CAL PF contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium.

AI/ML Overview

This document describes the XN CAL™ PF device, a calibrator for cell indices used with Sysmex XN series analyzers. The primary purpose of the submission (K141955) is to expand the compatible analyzers and extend the closed-vial stability.

Here's an analysis of the provided text in relation to acceptance criteria and study details:

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

The document does not explicitly state numerical acceptance criteria for the different studies. Instead, it states that "The resultant data set established that XN CAL PF 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." and "Study results show XN CAL PF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."

Based on the studies conducted and the claims made, the inferred performance metrics and outcomes are:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Open-Vial Stability	Maintain stability characteristics for 4 hours.	Demonstrated stability for 4 hours.
Closed-Vial Stability	Maintain stability characteristics for at least 49 days (for new claim).	Demonstrated stability for 49 days.
Precision Performance	Consistently reproducible results.	Demonstrated consistently reproducible results.
Substantial Equivalence	Performance comparable to the predicate device (XN CAL™ PF, K120747).	Demonstrated substantial equivalence to the predicate product in terms of safety and effectiveness for its intended use.
Safety and Effectiveness	Safe and effective for its intended use.	Concluded to be safe and effective for its intended use when used as instructed.
Fulfillment of Intended Use	Functions as a calibrator and for calibration verification on specified Sysmex XN series analyzers.	Fulfills its intended use as instructed in the Instructions for Use, including with the expanded list of XN-series analyzers (XN-10, XN-11, XN-20, XN-21).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide details on the specific sample sizes used for the Open-Vial Stability, Closed-Vial Stability, and Precision Performance studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Streck collected product performance data for the following studies".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to this device. XN CAL™ PF is a calibrator for laboratory analyzers, not an diagnostic imaging or AI-driven decision support tool that requires expert human interpretation to establish ground truth for a test set in the traditional sense. The "truth" or reference values for a calibrator are established through manufacturing processes and validation against primary reference methods or standards, not through expert consensus on cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies where human interpretation or diagnoses are being compared, often with an AI system. Ground truth for a laboratory calibrator is determined by its intrinsic properties and manufacturing metrology.

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

An MRMC study is not applicable to this type of device. XN CAL™ PF is a calibrator, not an AI system or software that assists human readers.

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

This concept is not applicable to XN CAL™ PF. It is a physical calibrator product, not a standalone algorithm.

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

The document does not explicitly state how the "ground truth" or reference values for the calibrator were established. However, for a calibrator, the ground truth would typically be established through:

Manufacturer's certified reference values: The company manufactures the calibrator to specific concentrations/values (e.g., PLT-F) and validates these values using highly accurate and precise reference methods or instruments, often traceable to international standards.
Traceability: The values are likely traceable to a recognized standard or method for cell enumeration, ensuring accuracy and consistency across different batches and against a predicate.

8. The sample size for the training set

This information is not applicable. XN CAL™ PF is a physical calibrator product; it does not involve machine learning or a "training set" in the context of AI.

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

This information is not applicable for the same reasons as #8.

Summary

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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 Manager 7002 South 109th Street Lavista, Nebraska 68128

Re: K141955

Trade/Device Name: XN CAL™ PF Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX Dated: October 24, 2014 Received: October 27, 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

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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/ResourcesforYou/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.

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)

K141955

Device Name XN CAL PF

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

PLT-F (10^3/ uL)

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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FOR FDA USE ONLY

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

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510(k) Summary

510(k) Submitter:	Streck7002 South 109th StreetLa Vista, NE 68128
Official Correspondent:	Deborah Kipp, Regulatory Affairs Manager
Address:	7002 South 109th Street; La Vista, NE 68128
Phone:	402-537-5215
Fax:	402-537-5317
Date Prepared:	April 18, 2014
Names

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

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

Predicate Device:

XN CAL™ PF (K120747)

Intended Use:

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

PLT-F (103/ µL)

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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 PF. The predicate device is shown in the "Comparison to Predicate Device" section.

Comparison to Predicate Device

	XN CAL™ PF (K120747)-PredicateDevice	XN CAL™ PF -Candidate Device	Same or Differences
IntendedUseStatement	XN CAL PF is used for calibration andcalibration verification of Sysmex XNseries (XN-10, XN-20) analyzers. Theassayed parameter is:PLT-F (103/μL)	XN CAL PF is used for calibration andcalibration verification of Sysmex XN series(XN-10, XN-11, XN-20, XN-21) analyzers.The assayed parameter is:PLT-F (103/μL)	Addition of the XN-11 andXN-21 analyzers.
Open VialStability	4 hours	4 hours	Same
Closed VialStability	35 days	49 days	Extension of Closed VialStability Dating to 49days
Reagents	XN CAL PF contains the following:stabilized red blood cell component(s),and stabilized platelet component(s) in apreservative medium.	XN CAL PF contains the following: stabilizedred blood cell component(s), and stabilizedplatelet 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 PF, 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 CAL PF 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 CAL PF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CAL PF 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.