XN CHECK BF

K120744 · Streck · JPK · Oct 19, 2012 · Hematology

Device Facts

• Record ID: K120744
• Device Name: XN CHECK BF
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: WBC-BF (103/μl), RBC-BF (106/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/μl)

Device Story

XN-CHECK™ BF is an in-vitro diagnostic control product; provides stabilized red and white blood cell components in preservative medium. Used by laboratory professionals to verify accuracy and precision of Sysmex XN-10 and XN-20 hematology analyzers. Supplied in two levels (low and medium) in 3 mL polypropylene vials. Stored at 2-8°C. Healthcare providers use the control to validate analyzer performance; results are compared against assay sheet ranges to ensure instrument reliability for patient body fluid sample analysis.

Clinical Evidence

Bench testing only. Studies included open-vial stability, closed-vial stability, and precision performance. Results confirmed the device is reproducible and stable for the claimed shelf life, meeting performance requirements for its intended use as a hematology control.

Technological Characteristics

Stabilized red and white blood cell components in preservative medium. Packaged in 3 mL polypropylene vials. Designed for Sysmex XN-10/XN-20 analyzers. Validated per CLSI H26-A2 and CLSI EP5-A2 standards.

Indications for Use

Indicated for use as an assayed hematology control for the Sysmex XN series (XN-10, XN-20) analyzers to verify control and calibration status. No specific patient population or contraindications described.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, 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

• Cell-Chex™ Auto (k053362)

Submission Summary (Full Text)

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K120744

OCT 1 9 2012

## 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 |
|-------------------|------------------------------------------------------|
|-------------------|------------------------------------------------------|

Official Correspondent: Deborah Kipp, Quality Assurance Coordinator [phone]

coordinates

Date Prepared: Revised-September 21, 2012

Name of Device: Trade Name: XN CHECK™ BF Common Name: Assayed Hematology Control Classification Name: Hematology Quality Control Mixture-(JPK-864.8625)

Cell-Chex Auto-K053362

Predicate Device:

## Description:

XN CHECK™ BF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white 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 (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.

### Intended Use:

XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (103/μl), RBC-BF (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)

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# Comparison to Predicate Device:

| | Cell-Chex™ Auto-K053362 | XN CHECK™ BF |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Predicate Product) | |
| Intended Use<br>Statement | Cell-Chex Auto is an assayed whole<br>blood control for evaluating the<br>accuracy and precision of<br>hematology instruments that<br>measure blood cell counts in patient<br>body fluid samples. | XN CHECK BF is used for control and<br>calibration verification of Sysmex<br>XN series (XN-10, XN-20) analyzers.<br>It is not, however, intended for actual<br>calibration of these analyzers.<br>Assayed parameters include:<br>WBC-BF (103/µl), RBC-BF (106/ µl),<br>MN# (103/µl), PMN# (103/µl),<br>MN% (%), PMN% (%), TC-BF#<br>(103/µl) |
| Open Vial Stability | 30 days | Same |
| Closed Vial<br>Stability | 75 days | 84 days |
| Reagents | Cell-Chex™ Auto contains<br>stabilized human red blood cells<br>and white blood cells in a<br>preservative medium. | XN CHECK BF contains the following:<br>stabilized red blood cell component(s)<br>and stabilized white blood cell<br>component(s) in a preservative<br>medium. |
| Storage<br>Conditions | 2 - 10°C | 2 - 8°C |

### Discussion of Tests and Test Results:

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

### Conclusions Drawn From Tests:

Study results show XN CHECK™ BF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK™ BF is a safe and effective product, which fulfills its intended use when used as instructions for Use.

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10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 19 2012

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

Re: k120744

Trade/Device Name: XN-CHECK™ BF Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK 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

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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.

Monai 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

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### Indication for Use Form

510(k) Number (if known): K 1207 44

Device Name: XN CHECK™ BF

Indications For Use:

XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (103/μl), RBC-BF (108/μl), MN# (10³/μl), PMN# (10³/μl), MN% (%), PMN% (%), TC-BF# (103/μl)

Prescription Use X (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 Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120744

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