(296 days)
Not Found
No
The device description and performance studies focus on the stability and precision of a hematology control material, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a hematology control used for calibration verification of laboratory analyzers, not for treating patients.
No
Explanation: The device description explicitly states that "XN CHECK is used for control and calibration verification of Sysmex XN series... analyzers. It is not, however, intended for actual calibration of these analyzers." This indicates it's a quality control material for other devices, not a diagnostic device itself used to diagnose patient conditions.
No
The device description clearly states that XN CHECK is a "three level hematology control" consisting of stabilized biological components packaged in vials. This indicates a physical, non-software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that XN CHECK is used for "control and calibration verification of Sysmex XN series... analyzers." These analyzers are used to perform diagnostic tests on blood samples.
- Device Description: The device description details the components of the control material, which are stabilized blood cell components in a preservative medium. This material is designed to be used in vitro (outside the body) with the analyzers.
- Performance Studies: The document mentions performance studies conducted to "substantiate the product performance claims." These studies are typical for IVD devices to demonstrate their safety and effectiveness for their intended use in a laboratory setting.
- Predicate Device: The document lists a predicate device with a K number (K141964), which is a regulatory identifier for medical devices, including IVDs, cleared by the FDA. The predicate device is also named "XN CHECK™," indicating it's a similar type of product.
Based on these points, XN CHECK fits the definition of an In Vitro Diagnostic device, as it is a reagent or material intended for use in a laboratory to verify the performance of an instrument used for diagnostic testing.
N/A
Intended Use / Indications for Use
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)
*Not Available on the XN-L.
Product codes
JPK
Device Description
XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials 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.
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
To substantiate the product performance claims for XN 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 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle with three human profiles incorporated into its design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem.
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: K160590
Trade/Device Name: XN CHECK TM Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 18, 2016 Received: October 20, 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 Parts 801 and 809); medical device reporting (reporting of
1
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/Medical Devices/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 /Industrv/default.htm.
Sincerely,
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
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Indications for Use
510(k) Number (if known) K160590
Device Name XN CHECK
Indications for Use (Describe)
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)
*Not Available on the XN-L.
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)
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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 17, 2016 |
| Names | |
Trade Name: Common Name: Classification Name: Product Code: Panel:
XN CHECK™ Assayed Hematology Control Hematology quality control mixture (864.8625) JPK Hematology
Predicate Device:
XN CHECK™ (K141964)
Intended Use:
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(108/μL), HGB(α/αL), HCT(%), MCV(fL), MCH(pq), MCHC(α/dL), PLT(103/μL), PLT-F*(10°/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10°/μL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103L), IG#(102), IPF(%), IPF# (103pL), RET#(108/pL), RET%, IRF%, RET-HE(pg), NRBC#* (10³/µL), NRBC%* (/100 WBC)
*Not Available on the XN-L.
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Description:
XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials 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 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#( $10^3/µL$ ),
NRBC% (/100 WBC) | XN CHECK is used for control and calibration
verification of Sysmex XN series (XN-10, XN-11,
XN-20, XN-21, XN-L) 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#* ( $10^3/µL$ ), NRBC%* (/100 WBC)
*Not Available on the XN-L. | Addition of XN-L Analyzer
Removal of the following
parameters on XN-L
instrument:
PLT-F( $10^3/μL$ )
IPF(%)
IPF# ( $10^3/μL$ )
NRBC# ( $10^3/µL$ )
NRBC% (/100 WBC) |
| Open Vial
Stability | 7 days | 7 days | Same |
| Closed Vial
Stability | 84 days | 84 days | Same |
| 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 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. | Same |
| Storage
Conditions | 2 - 8°C | 2 - 8°C | Same |
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Discussion of Tests and Test Results:
To substantiate the product performance claims for XN 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 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 CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.