XN CAL PF

K120747 · Streck · KRX · Oct 22, 2012 · Hematology

Device Facts

• Record ID: K120747
• Device Name: XN CAL PF
• Applicant: Streck
• Product Code: KRX · Hematology
• Decision Date: Oct 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8150
• Device Class: Class 2

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)

Device Story

XN-CAL PF is an in-vitro diagnostic calibrator; functions as a substitute for fresh whole blood. Contains stabilized red blood cell and platelet components in preservative medium. Used by laboratory personnel to calibrate and verify calibration of Sysmex XN-10 and XN-20 hematology analyzers specifically for the PLT-F channel. Product is packaged in polypropylene vials; stored at 2-8°C. Healthcare providers use the output (calibrated instrument performance) to ensure accuracy of patient platelet counts, facilitating reliable clinical decision-making in hematology diagnostics.

Clinical Evidence

No clinical data. Performance established via bench testing, including open-vial stability, closed-vial stability, and precision performance studies. Results demonstrated that the device is reproducible and stable for the claimed shelf life.

Technological Characteristics

Stabilized red blood cell and platelet components in preservative medium. Packaged in polypropylene vials. Designed for Sysmex XN-10/XN-20 analyzers. Storage: 2-8°C. Closed-vial stability: 35 days. Open-vial stability: 4 hours. References CLSI H26-A2 and CLSI EP5-A2 standards.

Indications for Use

Indicated for calibration and calibration verification of Sysmex XN-10 and XN-20 hematology analyzers for the PLT-F parameter. No specific patient population is described as this is an in-vitro diagnostic calibrator.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• X-CAL™ (K083200)

Submission Summary (Full Text)

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KI205747

## 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 | OCT 2 2 2012 |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------|
| Official Correspondent: | Deborah Kipp, Quality Assurance Coordinator<br>(402)537- 5215 | |
| Date Prepared: | Revised-September 21, 2012 | |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | XN CAL™ PF<br>Assayed Hematology Calibrator<br>Calibrator for Cell Indices (KRX-864.8150) | |
| Predicate Device: | X-CAL™ (K083200) Manufactured by Streck | |
| | | |

#### Description:

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.

#### 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 Use<br>Statement | X-CALTM is used to calibrate and<br>verify calibration of Sysmex<br>hematology analyzers. Refer to<br>product assay sheet. | XN CALTM PF is used for calibration<br>and calibration verification of<br>Sysmex XN series (XN-10, XN-20)<br>analyzers. The assayed parameter is:<br>PLT-F (103/μL) |
| | | |
| | | |
| Open Vial Stability | 24 hours | 4 hours |
| Closed Vial<br>Stability | 35 days | Same |
| Reagents | X-CALTM is composed of a mixture<br>of stabilized human and animal<br>blood cells. The cells are<br>suspended in a solution containing<br>biological salts and anti-microbial<br>preservatives. | XN CALTM PF contains the following:<br>stabilized red blood cell component(s),<br>and stabilized platelet component(s) in<br>a preservative medium. |
| Storage<br>Conditions | 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 [phone]. 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 [phone] or [phone] 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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