XN CAL

K160585 · Streck · KRX · Dec 22, 2016 · Hematology

Device Facts

• Record ID: K160585
• Device Name: XN CAL
• Applicant: Streck
• Product Code: KRX · Hematology
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8150
• Device Class: Class 2

Intended Use

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (10³/μL), RBC (10⁶/μL), HGB (g/dL), HCT (%), PLT (10³/μL), and RET (%).

Device Story

XN CAL is an in-vitro diagnostic calibrator consisting of stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in a preservative medium. It serves as a substitute for fresh whole blood to calibrate and verify hematology parameters (WBC, RBC, HGB, HCT, PLT, RET) on Sysmex XN-series analyzers. The product is packaged in polypropylene vials and stored at 2–8°C. It is used by laboratory personnel in clinical settings to ensure analyzer accuracy. The device output is a set of assayed values provided on a lot-specific sheet, which the healthcare provider uses to adjust or verify the performance of the hematology analyzer, ensuring reliable patient blood count results.

Clinical Evidence

No clinical data. Bench testing only. Multi-site reproducibility study (3 sites, 3 analyzers, 3 lots) and internal precision study (21 days) evaluated parameter recovery and variability (SD and %CV). Stability studies (open-vial 4-hour; closed-vial 35-day) confirmed performance per CLSI EP25-A guidelines.

Technological Characteristics

Stabilized blood components (RBC, WBC, PLT, nucleated RBC) in preservative medium. Polypropylene vials. Traceable to CLSI H7-A3, H15-A3, H26-A2, and ICSH reference methods. No electronic or software components; purely chemical/biological calibrator.

Indications for Use

Indicated for calibration and calibration verification of Sysmex XN series hematology analyzers (XN-10, XN-11, XN-20, XN-21, XN-L). For prescription use only.

Regulatory Classification

Identification

A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

Special Controls

*Classification.* Class II (special controls). 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 CAL (K141962)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image contains the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, unified image. The profiles are facing to the right and are meant to represent the department's commitment to health and well-being.

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: K160585

Trade/Device Name: XN CAL Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX 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

510(k) Number (if known)

Device Name XN CAL

Indications for Use (Describe)

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)

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: | Deborah Kipp, Regulatory Affairs Manager<br>7002 South 109th Street; La Vista, NE 68128<br>402-537-5215 |
| Fax: | 402-537-5317 |
| Date Prepared: | Revised: October 17, 2016 |
| Names | |

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

XN CAL™ Assayed Hematology Calibrator Calibrator for Cell Indices (864.8150) KRX Hematology

#### Predicate Device:

XN CAL™ (K141962)

#### Intended Use:

XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (103/pL), RBC (10°/µL), HGB (g/dL), HCT (%), PLT (103/ µL), and RET (%)

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

#### Description:

Per the FDA guidance document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)), a predicate device was selected in order to demonstrate substantial equivalence for XN CAL. The comparison to the "Comparison to Predicate Device" section.

## Comparison to Predicate Device

| | XN CAL™ (K141962)-Predicate Device | XN CAL™- Candidate Device | Same or Differences |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended<br>Use<br>Statement | XN CAL is used for the calibration and<br>calibration verification of Sysmex<br>XN series (XN-10, XN-11, XN-20, XN-<br>21) analyzers. Assayed parameters<br>include:<br>WBC ( $10^3$ /µL), RBC ( $10^6$ /µL),<br>HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), and<br>RET (%) | XN CAL is used for the calibration and<br>calibration verification of Sysmex<br>XN series (XN-10, XN-11, XN-20, XN-21,<br>XN-L) analyzers. Assayed parameters<br>include:<br>WBC ( $10^3$ /μL), RBC ( $10^6$ /μL),<br>HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), and<br>RET (%) | Addition of the XN-L<br>Analyzers. |
| Open Vial<br>Stability | 4 hours | 4 hours | Same |
| Closed Vial<br>Stability | 49 days | 35 days | Closed vial stability now<br>35 days. |
| Reagents | XN CAL contains the following: stabilized<br>red blood cell component(s), stabilized<br>white blood cell component(s), stabilized<br>platelet component(s), and stabilized<br>nucleated red blood cell component(s) in<br>a preservative medium. | XN CAL contains the following: stabilized red<br>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 |

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

#### Discussion of Tests and Test Results:

To substantiate the product performance claims for XN CAL, 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 CAL 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 CAL to be consistently reproducible, substantially equivalent to the products, and stable for the entire product dating. XN CAL is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.