(140 days)
Not Found
No
The document describes a control and calibration verification product for hematology analyzers. It details the components of the product and performance studies related to stability and precision. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is described as an in-vitro diagnostic product used for control and calibration verification of Sysmex XN series analyzers, not for treating any condition.
Yes
The 'Device Description' explicitly states that "XN CHECK™ is an in-vitro diagnostic product".
No
The device description explicitly states that XN CHECK is an in-vitro diagnostic product containing stabilized biological components (red blood cells, white blood cells, platelets, and nuclear components) packaged in vials. This indicates it is a physical reagent or control material, not a software-only device.
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 biological samples.
- Device Description: The device description clearly states that XN CHECK is an "in-vitro diagnostic product."
- Components: The components listed (stabilized red blood cells, white blood cells, platelets, etc.) are biological components used in laboratory testing.
- Performance Studies: The document mentions performance studies to "substantiate the product performance claims," which is typical for IVD devices to demonstrate their reliability for their intended use in a laboratory setting.
- Predicate Device: The mention of a predicate device (K120742; XN CHECK™) indicates that this device is being compared to a previously cleared IVD device.
All of these points strongly indicate that XN CHECK is an in vitro diagnostic device used in a laboratory setting to ensure the accuracy of other diagnostic instruments.
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-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/µL), IPF(%), IPF# (10^3/µL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(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 packaged in (4) welled vacuum formed clamshell ontainer 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To substantiate the product performance claims for XN CHECK, Streck collected product performance data for the following studies Open-Vial Stability, Closed-Vial Stability, and Precision Performance. 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 instructed in the 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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and professional, reflecting the department's role in promoting public health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
STRECK INC C/O MS. DEBORAH KIPP REGULATORY AFFAIRS MANGER 7002 SOUTH 109TH STREET OMAHA, NE 68128
Re: K141964
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 27, 2014 Received: October 28, 2014
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 vours.
Maria M. Chan -S
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
2
Indications for Use
510(k) Number (if known)
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-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/μL), IPF(%), IPF# (10^3/μL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
7002 South 109th Street
Omaha, 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
July 9, 2014 |
| 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™ (K120742)
Intended Use:
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(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(10"/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10")pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10%pL), LYMPH#(103/pL), MONO# (10%pL), EO#(10%pL), BASO#(103pL), IG#(103)µL), IPF(%), IPF# (109µL), RET#(109pL), RET%, IRF%, RET-HE(gg), NRBC#(10³/µL), NRBC% (/100 WBC)
4
Description:
XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(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 packaged in (4) welled vacuum formed clamshell ontainer with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.
Comparison to Predicate Device:
| | XN-CHECK (K120742)-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-20) analyzers. It is
not, however, intended for actual
calibration of these analyzers. Assayed
parameters include: | 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: | Addition of the XN-11 and
XN-21 analyzers.
Addition of an assayed
parameter, IPF# (10³/µL) |
| | RBC(10⁶µL), 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/μL), NEUT(%), LYMPH (%),
MONO(%), EO(%), BASO(%), IG(%),
NEUT#(10³/µL), LYMPH#(10³/µL),
MONO#(10³/μL), EO#(10³/μL),
BASO#(10³/μL), IG#(10³/µL), IPF(%),
RET#(10⁶/µL), RET%, IRF%, RET-
HE(pg), NRBC#(10³/μL),
NRBC% (/100 WBC) | 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/µL), NEUT(%), LYMPH
(%), MONO(%), EO(%), BASO(%), IG(%),
NEUT#(10³/µL), LYMPH#(10³/µL),
MONO#(10³/µL), EO#(10³/µL),
BASO#(10³/μL), IG#(10³/µL), IPF(%), IPF #
(10³/µL) RET#(10⁶/µL), RET%, IRF%, RET-
HE(pg), NRBC#(10³/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 |
5
Discussion of Tests and Test Results:
To substantiate the product performance claims for XN CHECK, Streck collected product performance data for the following studies Open-Vial Stability, Closed-Vial Stability, and Precision Performance. 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 instructed in the 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.