XN CHECK BF

K160588 · Streck · JPK · Dec 22, 2016 · Hematology

Device Facts

• Record ID: K160588
• Device Name: XN CHECK BF
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Dec 22, 2016
• 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-11, XN-20, XN-21, XN-L) 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 hematology control; contains stabilized red and white blood cell components in preservative medium. Used to evaluate accuracy and precision of Sysmex XN series hematology analyzers (XN-10, XN-11, XN-20, XN-21, XN-L). Product is provided in 3 mL polypropylene vials; stored at 2–8°C. Clinicians or laboratory technicians run the control material through the analyzer; the instrument measures hematology parameters (WBC-BF, RBC-BF, MN#, PMN#, MN%, PMN%, TC-BF#). Results are compared against assay sheet values to verify instrument performance and calibration status. Does not calibrate the instrument; serves as a quality control tool to ensure reliable patient sample analysis.

Clinical Evidence

No clinical data. Bench testing only. Precision studies (repeatability and reproducibility) were conducted following CLSI EP05-A3 guidelines across three sites using three lots of control material on the XN-L analyzer. Stability was verified per CLSI EP25-A for 30-day open-vial and 84-day closed-vial claims.

Technological Characteristics

Two-level assayed hematology control; stabilized red and white blood cell components in preservative medium. Packaged in 3 mL polypropylene vials. Storage: 2–8°C. Analyzed via Sysmex XN-L hematology analyzers. No electronic or software components; purely a chemical/biological control mixture.

Indications for Use

Indicated for use as a two-level assayed hematology control for monitoring the accuracy and precision of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. For prescription use only.

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

• XN CHECK™ BF (K141957)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Streck, Inc. Ms. Deborah Kipp Regulatory Affairs Manager 7002 South 109th Street La Vista, NE 68128

Re: K160588

Trade/Device Name: XN CHECK BFTM Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 17, 2016 Received: October 18, 2016

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] or at its Internet addresshttp://www.fda.gov/MedicalDevicesforYou /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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/ Industrv/default.htm.

Sincerely,

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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)

K160588

Device Name XN CHECK BF

#### Indications for Use (Describe)

XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (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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# 510(k) Summary

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>La Vista, NE 68128 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent:<br>Address:<br>Phone:<br>Fax:<br>Date Prepared: | Deborah Kipp, Requlatory Affairs Manager<br>7002 South 109" Street; La Vista, NE 68128<br>402-537-5215<br>402-537-5317<br>Revised: October 14, 2016 |
| Names | |

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

XN CHECK™ BF Assayed Hematology Control Hematology quality control mixture (864.8625) JPK Hematology

#### Predicate Device:

XN CHECK™ BF (K141957)

#### Intended Use:

XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) 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)

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#### Description:

XN CHECK™ BF is an in-vitro diagnostic, two level, hent contains the following: stabilized ted blood cell component(s) and stablized white blood cell component(s) in a preservative medium polypropylene plastic vials with screw caps with a 3 m fill. The vials will be packaged in (4) welled vacum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.

## Comparison to Predicate Device:

| | XN-CHECK BF (K141957) - Predicate Device | XN CHECKTM BF - Candidate Device | Same or Differences |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended<br>Use<br>Statement | XN CHECK BF is used for control and<br>calibration verification of Sysmex XN<br>series (XN-10, XN-11, XN-20, XN-21)<br>analyzers. It is not, however, intended<br>for actual calibration of these analyzers.<br>Assayed parameters include: | XN CHECK BF is used for control and<br>calibration verification of Sysmex XN series<br>(XN-10, XN-11, XN-20, XN-21, XN-L)<br>analyzers. It is not, however, intended for<br>actual calibration of these analyzers.<br>Assayed parameters include: | Addition of XN-L Analyzer |
| | WBC-BF (103/µl), RBC-BF (106/ µl), MN#<br>(103/µl), PMN# (103/µl), MN% (%),<br>PMN% (%), TC-BF# (103/µl) | WBC-BF (103/µL), RBC-BF (106/µL), MN#<br>(103/µL), PMN# (103/µL), MN%,<br>PMN%, TC-BF# (103/µL) | |
| Open Vial<br>Stability | 30 days | 30 days | Same |
| Closed Vial<br>Stability | 84 days | 84 days | Same |
| Reagents | 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 medium. | XN CHECK BF contains the following:<br>stabilized red blood cell component(s) and<br>stabilized white blood cell component(s) in a<br>preservative medium. | Same |
| Storage<br>Conditions | 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 CHECK BF, Streck collected product performance data for the following studies: Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability. The resultant data set established that XN CHECK BF 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 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 instructed in the Instructions for Use.