XN CAL

K120745 · Streck · KRX · Oct 19, 2012 · Hematology

Device Facts

• Record ID: K120745
• Device Name: XN CAL
• Applicant: Streck
• Product Code: KRX · Hematology
• Decision Date: Oct 19, 2012
• 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-20) analyzers. Assayed parameters include: WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)

Device Story

XN CAL is an in-vitro diagnostic hematology calibrator; contains stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in preservative medium. Packaged in 3 ml polypropylene vials. Used in clinical laboratory settings to calibrate and verify Sysmex XN-10 and XN-20 series analyzers. Laboratory technicians process the calibrator through the analyzer; the analyzer measures the sample to establish or verify instrument performance for WBC, RBC, HGB, HCT, PLT, and RET parameters. Ensures accurate clinical reporting of patient hematology results.

Clinical Evidence

Bench testing only. Studies included open-vial stability, closed-vial stability, and precision performance. Results confirmed the device is consistently reproducible and stable for the entire claimed product dating.

Technological Characteristics

In-vitro diagnostic calibrator; contains stabilized human/animal blood cell components (RBC, WBC, PLT, nucleated RBC) in preservative medium. Form factor: 3 ml polypropylene vials. Storage: 2-8°C. No electronic or software components; purely chemical/biological reagent.

Indications for Use

Indicated for calibration and calibration verification of Sysmex XN-10 and XN-20 hematology analyzers. No specific patient population or contraindications described.

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

• X-CAL (K083200)

Submission Summary (Full Text)

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16120745

## 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 | OCT 1 9 201 |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------|
| Official Correspondent: | Deborah Kipp, Quality Assurance Coordinator<br>(402)537- 5215 | |
| Date Prepared: | Revised-September 21, 2012 | |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | XN CAL TM<br>Assaved Hematology Calibrator<br>Calibrator for Cell Indices (KRX-864.8150) | |
| Predicate Device: | X-CAL™ (K083200) Manufactured by Streck | |
| Description: | | |

XN CAL™ 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 (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. The product must be stored at 2 - 8° C.

#### Intended Use:

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

WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)

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## Comparison to Predicate Device:

| | X-CALTM-K083200<br>(Predicate Product) | XN CALTM |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | X-CAL is used to calibrate and<br>verify calibration of Sysmex<br>hematology analyzers. Refer to<br>product assay sheet. | XN CAL is used for the calibration and<br>calibration verification of Sysmex<br>XN series (XN-10, XN-20) analyzers.<br>Assayed parameters include:<br>WBC (103/μL), RBC (106/μL),<br>HGB (g/dL), HCT (%), PLT (103/ μL),<br>and RET (%) |
| Open Vial Stability | 24 hours | 4 hours |
| Closed Vial<br>Stability | 35 days | Same |
| Reagents | X-CAL is composed of a mixture of<br>stabilized human and animal blood<br>cells. The cells are suspended in a<br>solution containing biological salts<br>and anti-microbial preservatives. | XN CAL 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. |
| Storage<br>Conditions | 2 - 8°C | Same |

### Discussion of Tests and Test Results:

The following studies were conducted to establish performance of XN CAL™. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CAL™ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

# Conclusions Drawn From Tests:

Study results show XN CAL™ to be consistently reproducible, substantially equivalent to the predicate 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 product package insert.

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10903 New Hampshire Avenue Silver Spring, MD 20993

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

Re: k120745

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

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

OCT 19 2012

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Page 2 – Ms. Deborah Kipp

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms of brovisions (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,

Maria M 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

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### Indication for Use Form

510(k) Number (if known): K 120745

Device Name: XN CAL™

Indications For Use:

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

WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)

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)

Serk R. Li

ion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120745

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