XN CAL™ is an in-vitro diagnostic product that 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. 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 (IFU) / assay sheet. The product must be stored at 2 - 8° C.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the XN CAL™ device, formatted as requested:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results for the XN CAL™ device against such criteria. Instead, it makes general claims about the device's performance relative to the predicate. The "Discussion of Tests and Test Results" section indicates that the studies demonstrated that XN CAL™ is "consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed."

Based on the text, the implicit acceptance criteria would be that the device:

Is consistently reproducible. (No specific numerical reproducibility target given.)
Is substantially equivalent to the predicate product (X-CAL™). (No specific equivalence margin or statistical criteria are provided.)
Is stable for the claimed shelf life. This includes:
- Open-Vial Stability: 4 hours (Claim based on "Comparison to Predicate Device" table).
- Closed-Vial Stability: 35 days (Claim based on "Comparison to Predicate Device" table).

The reported device performance, in the absence of numerical data, is a qualitative statement: "All testing showed that XN CAL™ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed."

Table of Implicit Acceptance Criteria and Reported Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (Qualitative)
Consistent Reproducibility	"consistently reproducible"
Substantial Equivalence	"substantially equivalent to the predicate product"
Open-Vial Stability (4 hours)	"stable for the shelf life claimed" (supporting the 4-hour open-vial stability)
Closed-Vial Stability (35 days)	"stable for the shelf life claimed" (supporting the 35-day closed-vial stability)
Safety and Effectiveness	"safe and effective product, which fulfills its intended use when used as instructed"

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

The 510(k) summary does not specify the sample size used for the test set in the Open-Vial Stability, Closed-Vial Stability, or Precision Performance studies.

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). As the submitter is Streck, a US-based company, and the context is a US regulatory filing, it is highly probable the data was generated in the US or under US guidance, but this is not explicitly confirmed. The studies are described in the past tense ("were conducted"), suggesting they were completed prior to submission, but does not explicitly state if they were retrospective or prospective.

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

This information is not applicable and not provided in the document. XN CAL™ is a quality control material (calibrator) for hematology analyzers. The "ground truth" for calibrator performance is established through laboratory methods and reference standards, not by expert interpretation of patient data as might be the case for diagnostic imaging or AI devices. The parameters (WBC, RBC, HGB, HCT, PLT, RET) are quantitative measurements.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication typically refers to resolving disagreements among multiple human readers/experts. Since the "ground truth" for a calibrator is based on instrumental measurements and adherence to specifications, not expert consensus on qualitative interpretation, an adjudication method is not relevant here.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret medical cases. XN CAL™ is a calibrator, not an AI diagnostic device. Therefore, AI assistance for human readers is not a component of this device's intended use.

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

A standalone performance study was not done/is not applicable in the context of an algorithm. XN CAL™ is a physical chemical product (an in-vitro diagnostic product), not a software algorithm. Its performance is evaluated through laboratory stability and precision testing on hematology analyzers, not through an algorithm's standalone accuracy.

7. The Type of Ground Truth Used

The "ground truth" for performance of XN CAL™ would be established through a combination of:

Reference Methods/Standard Measurements: The concentrations/values of the assayed parameters (WBC, RBC, HGB, etc.) in the calibrator material would be determined using highly accurate and precise reference methods or against established reference materials.
Predicate Device Performance: A key aspect of the "ground truth" in this 510(k) is the performance of the legally marketed predicate device (X-CAL™), as the newer device (XN CAL™) aims to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable and not provided. XN CAL™ is a physical calibrator material, not a machine learning algorithm that requires a "training set."

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

This information is not applicable and not provided as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

16120745

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128	OCT 1 9 201
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 TMAssaved Hematology CalibratorCalibrator for Cell Indices (KRX-864.8150)
Predicate Device:	X-CAL™ (K083200) Manufactured by Streck
Description:

Intended Use:

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

WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)

{1}------------------------------------------------

Comparison to Predicate Device:

	X-CALTM-K083200(Predicate Product)	XN CALTM
Intended UseStatement	X-CAL is used to calibrate andverify calibration of Sysmexhematology analyzers. Refer toproduct assay sheet.	XN CAL is used for the calibration andcalibration verification of SysmexXN series (XN-10, XN-20) analyzers.Assayed parameters include:WBC (103/μL), RBC (106/μL),HGB (g/dL), HCT (%), PLT (103/ μL),and RET (%)
Open Vial Stability	24 hours	4 hours
Closed VialStability	35 days	Same
Reagents	X-CAL is composed of a mixture ofstabilized human and animal bloodcells. The cells are suspended in asolution containing biological saltsand anti-microbial preservatives.	XN CAL 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.
StorageConditions	2 - 8°C	Same

Discussion of Tests and Test Results:

The following studies were conducted to establish performance of XN CAL™. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CAL™ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

Study results show XN CAL™ to be consistently reproducible, substantially equivalent to the predicate 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 product package insert.

{2}------------------------------------------------

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 its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

Re: K120745

Trade/Device Name: XN-CALTM 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

OCT 19 2012

{3}------------------------------------------------

Page 2 – Ms. Deborah Kipp

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms of brovisions (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 Chan

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

{4}------------------------------------------------

Indication for Use Form

510(k) Number (if known): K 120745

Device Name: XN CAL™

Indications For Use:

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

WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)

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)

Serk R. Li

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

510(k) K120745

Page _ 1 _ of 1

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.