XN CAL™ PF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), and stabilized platelet 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 (5) welled or (1) 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, while noting the limitations in what can be extracted for a medical device approval that is not based on AI/ML.

Important Note: The provided document is a 510(k) summary for a hematology calibrator (XN CAL™ PF), not an AI/ML powered medical device. Therefore, many of the requested points related to AI/ML (like training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of device and will not be found in the document. This device is an in-vitro diagnostic product used for instrument calibration.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table format for performance metrics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device and stability studies.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	To be used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers for the PLT-F parameter.	XN CAL™ PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers for the PLT-F parameter. (Matches)
Open Vial Stability	Comparable to predicate device (24 hours)	4 hours
Closed Vial Stability	Comparable to predicate device (35 days)	35 days (Same as predicate)
Reagents	Similar composition to predicate device.	Stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium. (Similar, but not identical composition noted for predicate)
Storage Conditions	Same as predicate (2 - 8°C)	2 - 8°C (Same as predicate)
Overall Performance	Consistently reproducible and substantially equivalent to predicate product.	All testing (Open-Vial Stability, Closed-Vial Stability, and Precision Performance) showed that the device was reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Study Details (Applicable to XN CAL™ PF)

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

Sample Size for Test Set: The document does not specify a numerical sample size for the test sets used in the Open-Vial Stability, Closed-Vial Stability, and Precision Performance studies. It only states that "all testing showed" the results.
Data Provenance: Not specified in the document. The studies were likely conducted internally by Streck.

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

Not Applicable. This is a calibrator for a hematology analyzer, not a diagnostic device requiring human expert ground truth for interpretation of images or patient data. Its "ground truth" is its own verified composition and stability, and its performance is evaluated against the instrument's measurements.

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

Not Applicable. No human adjudication is involved for this type of 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. This is not an AI/ML-powered device or one that involves human readers interpreting cases.

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

Not Applicable. This is not an algorithm. The "performance" of the device is its ability to properly calibrate the instrument and remain stable.

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

For this device, the "ground truth" for its performance evaluation would likely be:
- Defined values/concentrations for the stabilized red blood cell and platelet components (for calibration accuracy).
- Time-based measurements against predefined stability limits (for open and closed vial stability).
- Repeatability measurements (for precision performance).
- These are internal quality control and validation metrics, not external clinical ground truth derived from human experts or pathology.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary

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KI205747

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128	OCT 2 2 2012
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 CAL™ PFAssayed Hematology CalibratorCalibrator for Cell Indices (KRX-864.8150)
Predicate Device:	X-CAL™ (K083200) Manufactured by Streck

Description:

Intended Use:

XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is:

PLT-F (103/pL)

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Comparison to Predicate Device:

	X-CALTM-K083200	XN CALTM PF
	(Predicate Product)
Intended UseStatement	X-CALTM is used to calibrate andverify calibration of Sysmexhematology analyzers. Refer toproduct assay sheet.	XN CALTM PF is used for calibrationand calibration verification ofSysmex XN series (XN-10, XN-20)analyzers. The assayed parameter is:PLT-F (103/μL)


Open Vial Stability	24 hours	4 hours
Closed VialStability	35 days	Same
Reagents	X-CALTM is composed of a mixtureof stabilized human and animalblood cells. The cells aresuspended in a solution containingbiological salts and anti-microbialpreservatives.	XN CALTM PF contains the following:stabilized red blood cell component(s),and stabilized platelet component(s) ina preservative medium.
StorageConditions	2 - 8°C	Same

Discussion of Tests and Test Results:

Discussion of rests and Test Resulter
The following studies were conducted to establish performance of XN CAL™ PF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that were open fiar Stablity, eloces vilusible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

Outlations show XN CAL™ PF to be consistently reproducible, substantially equivalent to the Study Tesults Snow XN Orte - 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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

10903 New Hampshire Avenue Silver Spring, MD 20993

Streck

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

Re: K120747

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: 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 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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

OCT 22 2012

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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.

Maria M Clan

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): K120747

Device Name: XN CAL™ PF

Indications For Use:

XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is:

PLT-F (103/pL)

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/

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120747

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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.