K Number

Device Name

XN-L CHECK

Manufacturer

STRECK

Date Cleared

2016-12-22

(296 days)

Product Code

JPK PAN

Regulation Number

864.8625

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 (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/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).

Device 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141964

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a hematology control and calibration verification product, not a device that processes data or images using AI/ML. The studies mentioned are standard performance and stability tests for such a product.

Therapeutic

No
The device is described as an "in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product" used for "control and calibration verification of Sysmex XN-L analyzers," not for treating a condition.

Diagnostic

The device description explicitly states it is an "in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product" used for "control and calibration verification of Sysmex XN-L analyzers." It is not used to diagnose a patient directly but rather to verify the accuracy of another diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it 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." This indicates it is a physical reagent product, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Device Description" section explicitly states: "XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product..."

This statement directly identifies the device as an in-vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (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).

Product codes (comma separated list FDA assigned to the subject device)

JPK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141964

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
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).(b)
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.

Summary

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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.

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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:

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510(k) Summary

| 510(k) Submitter: | Streck
7002 South 109th Street
La Vista, NE 68128 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent:
Address:
Phone:
Fax:
Date Prepared: | Deborah Kipp, Regulatory Affairs Manager
7002 South 109th Street; La Vista, NE 68128
402-537-5215
402-537-5317
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).

Description:

Comparison to Predicate Device:

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

Discussion of Tests and Test Results:

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.