XN CHECK BF

K141957 · Streck · JPK · Dec 5, 2014 · Hematology

Device Facts

• Record ID: K141957
• Device Name: XN CHECK BF
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Dec 5, 2014
• 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) 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), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)

Device Story

XN CHECK BF is an in-vitro diagnostic hematology control; consists of stabilized red and white blood cell components in preservative medium. Packaged in 3ml polypropylene vials. Used in clinical laboratories to verify calibration and monitor performance of Sysmex XN series analyzers (XN-10, XN-11, XN-20, XN-21). Device provides assayed values for WBC-BF, RBC-BF, MN#, PMN#, MN%, PMN%, and TC-BF#. Laboratory personnel process the control through the analyzer; results are compared against expected values to ensure system accuracy and reproducibility. Benefits include reliable quality control for body fluid analysis, ensuring clinical diagnostic accuracy.

Clinical Evidence

Bench testing only. Studies included open-vial stability (30 days), closed-vial stability (84 days), and precision performance. Data demonstrated consistent reproducibility and stability for the entire product dating, confirming substantial equivalence to the predicate.

Technological Characteristics

Stabilized red and white blood cell components in preservative medium. Packaged in 3ml polypropylene vials. Storage at 2-8°C. No electronic or software components; purely a chemical/biological control mixture.

Indications for Use

Indicated for use as an in-vitro diagnostic control material for monitoring the accuracy and precision of Sysmex XN-10, XN-11, XN-20, and XN-21 hematology analyzers in clinical laboratory settings.

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 (k120744)

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 5, 2014

STRECK, INC. C/O MS DEBORAH KIPP REGULATORY AFFAIRS MANAGER 7002 SOUTH 109TH STREET LA VISTA, NE 68128

Re: k141957

Trade/Device Name: XN CHECK™ BF Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: October 24, 2014 Received: October 27, 2014

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 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Maria M. Chan -S

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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## Indications for Use

510(k) Number (if known)

k141957

Device Name XN CHECK BF

Indications for Use (Describe)

XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) 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), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)

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, Regulatory Affairs Manager<br>7002 South 109th Street; La Vista, NE 68128<br>402-537-5215<br>402-537-5317<br>April 18, 2014 |
| Names | |
| Trade Name: | XN CHECKTM BF |
| Common Name: | Assayed Hematology Control |
| Classification Name: | Hematology quality control mixture (864.8625 |
| Product Code: | JPK |
| Panel: | Hematology |

#### Predicate Device:

XN CHECK™ BF (K120744)

#### Intended Use:

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

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

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#### Description:

XN CHECK™ BF is an in-vitro diagnostic product 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 a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are at 2 - 8° C. Comparison to Predicate Device:

| | XN-CHECK BF (K120744)-Predicate Device | XN CHECK™ BF -Candidate Device | Same or Differences |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use<br>Statement | XN CHECK BF is used for control and<br>calibration verification of Sysmex XN<br>series (XN-10, XN-20) analyzers. It is<br>not, however, intended for actual<br>calibration of these analyzers. Assayed<br>parameters include:<br><br>WBC-BF (10³/µl), RBC-BF (10⁶/µl),<br>MN# (10³/µl), PMN# (10³/µl), MN% (%),<br>PMN% (%), TC-BF# (10³/µl) | XN CHECK BF is used for control and<br>calibration verification of Sysmex XN series<br>(XN-10, XN-11, XN-20, XN-21) analyzers. It<br>is not, however, intended for actual<br>calibration of these analyzers. Assayed<br>parameters include:<br><br>WBC-BF (10³/µl), RBC-BF (10⁶/ μl), MN#<br>(10³/µl), PMN# (10³/µl), MN% (%), PMN%<br>(%), TC-BF# (10³/µl) | Addition of the XN-11 and<br>XN-21 analyzers. |
| 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: Open-Vial Stability, Closed-Vial Stability, and Precision Performance. 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.