XN-L CHECK

K160586 · Streck · JPK · Dec 22, 2016 · Hematology

Device Facts

• Record ID: K160586
• Device Name: XN-L CHECK
• 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-L CHECK™ is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include: RBC (10⁶/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10³/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10³/μL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10³/μL), LYMPH# (10³/μL), MONO# (10³/μL), EO# (10³/μL), BASO# (10³/μL), IG# (10³/μL), RET# (10⁶/μL), RET%, IRF%, RET-He (pg).

Device Story

XN-L CHECK™ is an in-vitro diagnostic hematology control; contains stabilized red blood cells, white blood cells, and platelets in preservative medium. Used in clinical laboratories to verify accuracy and precision of Sysmex XN-L analyzers; provides three levels of control material. Laboratory professionals process vials on the analyzer; output consists of assayed hematology parameters. Results allow clinicians to verify instrument performance and ensure reliability of patient sample analysis. Benefits include quality assurance for hematology testing.

Clinical Evidence

No clinical data. Bench testing only. Multi-site reproducibility study (3 sites, 3 operators, 3 lots) evaluated precision across 90 measurements per lot/level. Internal precision study evaluated performance over 21 days. Stability studies (open and closed-vial) performed per CLSI EP25-A.

Technological Characteristics

Tri-level hematology control; stabilized RBC, WBC, and platelet components in preservative medium. Packaged in 3 mL polypropylene vials. Storage 2–8°C. No energy source. Standalone control material.

Indications for Use

Indicated for use by laboratory professionals as a tri-level hematology control to evaluate the accuracy and precision of Sysmex XN-L 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™ (K141964)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.

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 LaVista, NE 68128

Re: K160586

Trade/Device Name: XN-L CHECK™ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 15, 2016 Received: December 16, 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 Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

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 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 yours,

# 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

{2}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name XN-L CHECK

Indications for Use (Describe)

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assaved parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (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/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/μL), RET%, IRF%, RET-He (pg).

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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>Revised October 19, 2016 |
| Names | |

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

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

## Predicate Device:

XN CHECK™ (K141964)

#### Intended Use:

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (108/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (103/μL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (103/μL), NEUT (%), LYMPH (%), MÖNO (%), EÒ (%), BASO (%), ÍG (%), NÉUT# (10°µL), É YMPHÆ (10°µL),
MONO# (10³µL), EO# (10³µL), BASO# (10³µL), IG# (10³µL), RET# (10ºµL), RET%, IRF%, RET-He (pg).

{4}------------------------------------------------

## Description:

XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

## Comparison to Predicate Device:

| | XN-CHECK (K141964)- Predicate Device | XN-L CHECK™-Candidate Device | Same or Differences |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use<br>Statement | XN CHECK is used for control and calibration<br>verification of Sysmex XN series (XN-10, XN-<br>11, XN-20, XN-21) analyzers. It is not,<br>however, intended for actual calibration of<br>these analyzers. Assayed parameters<br>include:<br>RBC( $10^6$ /μL), HGB(g/dL), HCT(%), MCV(fL),<br>MCH(pg), MCHC(g/dL), PLT( $10^3$ /µL),<br>PLT-F( $10^3$ /μL), RDW-SD(fL), RDW-CV(%),<br>MPV(fL), WBC( $10^3$ /μL), NEUT(%), LYMPH<br>(%), MONO(%), EO(%), BASO(%), IG(%),<br>NEUT#( $10^3$ /μL), LYMPH#( $10^3$ /μL),<br>MONO#( $10^3$ /μL), EO#( $10^3$ /μL),<br>BASO#( $10^3$ /µL), IG#( $10^3$ /µL), IPF(%), IPF #<br>( $10^3$ /µL) RET#( $10^6$ /µL), RET%, IRF%, RET-<br>HE(pg), NRBC#( $10^3$ /uL),<br>NRBC% (/100 WBC) | XN-L CHECK is used for control and<br>calibration verification of Sysmex XN-L<br>analyzers. It is not, however, intended for<br>actual calibration of this analyzer.<br>Assayed parameters include:<br>RBC ( $10^6$ /µL), HGB (g/dL), HCT (%), MCV<br>(fL), MCH (pg), MCHC (g/dL), PLT<br>( $10^3$ /μL), RDW-SD (fL), RDW-CV (%), MPV<br>(fL), WBC ( $10^3$ /µL), NEUT (%), LYMPH<br>(%), MONO (%), EO (%), BASO (%), IG (%),<br>NEUT# ( $10^3$ /μL), LYMPH# ( $10^3$ μL),<br>MONO# ( $10^3$ /µL), EO# ( $10^3$ /µL), BASO#<br>( $10^3$ /µL), IG# ( $10^3$ /µL), RET# ( $10^6$ /µL),<br>RET%, IRF%, RET-He (pg). | Product is a control for<br>XN-L analyzer.<br>The following<br>measurands are not<br>available on XN-L<br>CHECK or the XN-L<br>analyzer:<br>IPF(#)<br>IPF(%)<br>NRBC#( $10^3$ /µL)<br>NRBC%(/100WBC) |
| Open Vial<br>Stability | 7 days | 15 days | Increased Open Vial<br>Stability to 15 days |
| Closed Vial<br>Stability | 84 days | 100 days | Increased Closed Vial<br>Stability to 100 days |
| 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-L CHECK contains the following:<br>stabilized red blood cell component(s),<br>stabilized white blood cell component(s), and<br>stabilized platelet component(s) in a<br>preservative medium. | Removal of nucleated red<br>blood cell component(s) |
| Storage<br>Conditions | 2 - 8°C | 2 - 8°C | Same |

{5}------------------------------------------------

## Discussion of Tests and Test Results:

To substantiate the product performance claims for XN-L CHECK, 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-L 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 instructions for Use.

## Conclusions Drawn From Tests:

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