XN CHECK

K120742 · Streck · JPK · Oct 19, 2012 · Hematology

Device Facts

• Record ID: K120742
• Device Name: XN CHECK
• 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 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: RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONQ(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)

Device Story

XN-CHECK is an in-vitro diagnostic hematology control; contains stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in preservative medium. Provided in three levels (low, medium, high) in 3mL polypropylene vials. Used by laboratory professionals to verify accuracy and precision of Sysmex XN-10 and XN-20 analyzers. Device is processed by the analyzer; results are compared against assigned values provided in the assay sheet. Enables monitoring of instrument performance and quality assurance; does not perform actual calibration. Stored at 2-8°C.

Clinical Evidence

No clinical data. Analytical performance testing only. Precision/reproducibility evaluated across 4 Sysmex XN-10/XN-20 analyzers at 3 sites using 3 lots. All CV% results met acceptance criteria for all measurands. Stability validated via CLSI EP5-A2 methods.

Technological Characteristics

Stabilized red blood cell, white blood cell, platelet, and nucleated red blood cell components in preservative medium. Three-level tri-level control. Polypropylene vials. Refrigerated storage (2-8°C). Complies with CLSI H26-A2 and CLSI EP5-A2 standards.

Indications for Use

Indicated for use by laboratory professionals as a hematology quality control mixture for Sysmex XN-10 and XN-20 analyzers to verify accuracy and precision of assayed parameters. 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

• e-CHECK (XE)™ (K063218)

Submission Summary (Full Text)

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

510(k) Summary of Safety and Effectiveness

(5742

OCT 1 9 2012 .

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Official Correspondent: | Deborah Kipp, Quality Assurance Coordinator<br>[phone] |
| Date Prepared: | Revised-September 21, 2012 |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | XN CHECK™<br>Assayed Hematology Control<br>Hematology quality control mixture (JPK-864.8625) |
| Predicate Device: | e-CHECK (XE)™-K063218 |
| Description: | |

XN CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red 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 Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.

### Intended Use:

XN CHECK 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:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONQ(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)

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

# Comparison to Predicate Device:

: :

| | e-CHECK (XE)® -K063218<br>(Predicate Product) | XN CHECK™ |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use<br>Statement | e-CHECK (XE)® is intended to be used<br>as a control for complete blood cell count<br>(CBC), white blood cell differential,<br>reticulocyte, and nucleated red blood cell<br>(NRBC) parameters on Sysmex XE-<br>Series instruments. | XN CHECK is used for control and calibration<br>verification of Sysmex XN series (XN-10,<br>XN-20) analyzers. It is not, however, intended<br>for actual calibration of these analyzers.<br>Assayed parameters 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#( $10^3/μL$ ), MONO#( $10^3/μL$ ),<br>EO#( $10^3/μL$ ), BASO#( $10^3/μL$ ),<br>IG#( $10^3/μL$ ), IPF(%), RET#( $10^3/μL$ ), RET%,<br>IRF%, RET-HE(pg), NRBC#( $10^3/μL$ ), NRBC%<br>(/100 WBC) |
| Open Vial<br>Stability | 7 days | Same |
| Closed<br>Vial<br>Stability | 84 days. | Same |
| Reagents | The e-CHECK(XE)® control consists of<br>stabilized human and animal blood. This<br>product is provided in three levels that<br>vary in concentration by parameters.<br>Vials are labeled L1, L2, and L3. | 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. |
| Storage<br>Conditions | 2 - 8°C | Same |

.

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

# Discussion of Tests and Test Results:

DIScussion of Tests and Test Nesults.
The following studies were conducted to establish performance of XN CHECK™ and teach of the The following studies were vondation to libre in performance. All testing showed that were Open Phar Stablity, Olosca Vial Stablity, and President to the predicate product and stable for the shelf life claimed.

## Conclusions Drawn From Tests:

Conclusions brawn i ronr rests.
Study results show XN CHECK™ to be consistently consistently equivals and effective Study Tesulis Show XN OFEON - to be re product dating. XN CHECK™ is a safe and effective product, which fulfills its intended use when used as instructions for Use.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.

#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 19 2012

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

Re: k120742

Trade/Device Name: XN-CHECK™ 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 for ass barber 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 I ou may arous 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 If your device is classified (boo are ) Existing major regulations affecting your device can be four di 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 r toase be devices and internination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Or ice related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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,

mana in 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

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

#### Indication for Use Form

510(k) Number (if known): K120742

Device Name: XN CHECK™

Indications For Use:

XN CHECK 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:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (1%), MONO(%), EQ(%), BASO(%), IG(%), NEUT#(103)pL), LYMPH#(103/pL), MONO# (10°/μL), MONO®(L), BASO#(10³), 1G#(10³/pL), IPF(%), RET#(10º/pL), RET%, IRF%, RET-HE(pg), NRBC#(103/µL), NRBC% (/100 WBC)

Prescription Use × (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 Diagnostie Device Evaluation and Safety

510(k) K120742

Page 1 of 1