XN CHECK

K141964 · Streck · JPK · Dec 5, 2014 · Hematology

Device Facts

• Record ID: K141964
• Device Name: XN CHECK
• 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 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: RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/uL), IPF(%), IPF# (10^3/uL), RET#(10^6/uL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)

Device Story

XN-CHECK is a tri-level (low, medium, high) hematology control product containing stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in a preservative medium. It is used by laboratory professionals to evaluate the accuracy and precision of Sysmex XN series analyzers. The device is supplied in 3mL polypropylene vials. Users process the control through the analyzer; the instrument measures the sample and produces quantitative results for various hematology parameters. These results are compared against assigned values provided in the assay sheet to verify instrument performance and calibration status. The control helps ensure reliable clinical decision-making by confirming that the analyzer is operating within established specifications.

Clinical Evidence

No clinical data. Bench testing only. Precision and reproducibility were validated across three lots of control material using multiple Sysmex XN-20 and XN-21 analyzers at three sites. Performance was evaluated against CV% acceptance criteria for all assayed parameters, including the new IPF# parameter, confirming consistent recovery throughout the 84-day closed-vial and 7-day open-vial stability claims.

Technological Characteristics

Tri-level hematology control mixture containing stabilized RBCs, WBCs, platelets, and nucleated RBCs in preservative medium. Packaged in 3mL polypropylene vials. Storage at 2-8°C. Designed for use with Sysmex XN series automated hematology analyzers. Complies with CLSI H26-A2 and EP5-A2 guidelines for validation and precision performance.

Indications for Use

Indicated for use by laboratory professionals as an in-vitro diagnostic control and calibration verification material for Sysmex XN series (XN-10, XN-11, XN-20, XN-21) hematology analyzers.

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 (K120742)

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 MANGER 7002 SOUTH 109TH STREET OMAHA, NE 68128

Re: K141964

Trade/Device Name: XN CHECK TM Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 27, 2014 Received: October 28, 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/Industry/default.htm.

Sincerely vours.

# 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)

k141964

Device Name XN CHECK

Indications for Use (Describe)

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

RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/μL), IPF(%), IPF# (10^3/μL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

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## 510(k) Summary

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, 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>July 9, 2014 |
| Names | |

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

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

#### Predicate Device:

XN CHECK™ (K120742)

#### Intended Use:

XN CHECK 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:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(10"/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10")pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10%pL), LYMPH#(103/pL), MONO# (10%pL), EO#(10%pL), BASO#(103pL), IG#(103)µL), IPF(%), IPF# (109µL), RET#(109pL), RET%, IRF%, RET-HE(gg), NRBC#(10³/µL), NRBC% (/100 WBC)

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#### Description:

XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 ml fill. The vials will be packaged in (4) welled vacuum formed clamshell ontainer with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

### Comparison to Predicate Device:

| | XN-CHECK (K120742)-Predicate<br>Device | XN CHECK™-Candidate Device | Same or Differences |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended<br>Use<br>Statement | XN CHECK 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: | XN CHECK 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: | Addition of the XN-11 and<br>XN-21 analyzers.<br>Addition of an assayed<br>parameter, IPF# (10³/µL) |
| | RBC(10⁶µL), HGB(g/dL), HCT(%),<br>MCV(fL), MCH(pg), MCHC(g/dL),<br>PLT(10³/μL), PLT-F(10³/μL), RDW-<br>SD(fL), RDW-CV(%), MPV(fL),<br>WBC(10³/μL), NEUT(%), LYMPH (%),<br>MONO(%), EO(%), BASO(%), IG(%),<br>NEUT#(10³/µL), LYMPH#(10³/µL),<br>MONO#(10³/μL), EO#(10³/μL),<br>BASO#(10³/μL), IG#(10³/µL), IPF(%),<br>RET#(10⁶/µL), RET%, IRF%, RET-<br>HE(pg), NRBC#(10³/μL),<br>NRBC% (/100 WBC) | RBC(10⁶/µL), HGB(g/dL), HCT(%), MCV(fL),<br>MCH(pg), MCHC(g/dL), PLT(10³/µL),<br>PLT-F(10³/μL), RDW-SD(fL), RDW-CV(%),<br>MPV(fL), WBC(10³/µL), NEUT(%), LYMPH<br>(%), MONO(%), EO(%), BASO(%), IG(%),<br>NEUT#(10³/µL), LYMPH#(10³/µL),<br>MONO#(10³/µL), EO#(10³/µL),<br>BASO#(10³/μL), IG#(10³/µL), IPF(%), IPF #<br>(10³/µL) RET#(10⁶/µL), RET%, IRF%, RET-<br>HE(pg), NRBC#(10³/μL),<br>NRBC% (/100 WBC) | |
| Open Vial<br>Stability | 7 days | 7 days | Same |
| Closed Vial<br>Stability | 84 days | 84 days | Same |
| Reagents | XN CHECK contains the following:<br>stabilized red blood cell component(s),<br>stabilized white blood cell component(s),<br>stabilized platelet component(s), and<br>stabilized nucleated red blood cell<br>component(s) in a preservative medium. | XN CHECK contains the following: stabilized<br>red blood cell component(s), stabilized white<br>blood cell component(s), stabilized platelet<br>component(s), and stabilized nucleated red<br>blood cell component(s) in a preservative<br>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, 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 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 to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.