(221 days)
Not Found
No
The device description and intended use indicate it is a control and calibration verification material, not a software or analytical device that would typically incorporate AI/ML. The summary focuses on the stability and performance of the control material itself.
No
The device is used for control and calibration verification of analyzers, not for treating patients.
No
The device description explicitly states that XN CHECK 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." Its intended use is for "control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers," not for diagnosing patients directly. It is a control material used with diagnostic devices, not a diagnostic device itself.
No
The device description explicitly states that the product contains physical components such as stabilized blood cell components in a preservative medium, packaged in plastic vials. This indicates it is a physical in-vitro diagnostic product, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that XN CHECK is used for "control and calibration verification of Sysmex XN series... analyzers." This indicates it's used to assess the performance of other diagnostic devices.
- Device Description: The "Device Description" section clearly labels XN CHECK as an "in-vitro diagnostic product."
- Composition: The description of the components (stabilized blood cell components in a preservative medium) aligns with the typical composition of IVD control materials.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K063218) is a strong indicator that this device is being compared to another legally marketed IVD.
Therefore, based on the provided information, XN CHECK is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONQ(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), 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 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 (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product must be stored at 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)
The following studies were conducted to establish performance of XN CHECK™ and teach of the The following studies were vondation to libre in performance. All testing showed that were Open Phar Stablity, Olosca Vial Stablity, and President to the predicate product and stable for the shelf life claimed.
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.
e-CHECK (XE)™-K063218
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
510(k) Summary of Safety and Effectiveness
(5742
OCT 1 9 2012 .
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Official Correspondent: | Deborah Kipp, Quality Assurance Coordinator
(402)537-5215 |
| Date Prepared: | Revised-September 21, 2012 |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | XN CHECK™
Assayed Hematology Control
Hematology quality control mixture (JPK-864.8625) |
| Predicate Device: | e-CHECK (XE)™-K063218 |
| Description: | |
XN CHECK™ 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 (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.
Intended Use:
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:
RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONQ(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)
1
Comparison to Predicate Device:
: :
| | e-CHECK (XE)® -K063218
(Predicate Product) | XN CHECK™ |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use
Statement | e-CHECK (XE)® is intended to be used
as a control for complete blood cell count
(CBC), white blood cell differential,
reticulocyte, and nucleated red blood cell
(NRBC) parameters on Sysmex XE-
Series instruments. | 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:
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(%), RET#( $10^3/μL$ ), RET%,
IRF%, RET-HE(pg), NRBC#( $10^3/μL$ ), NRBC%
(/100 WBC) |
| Open Vial
Stability | 7 days | Same |
| Closed
Vial
Stability | 84 days. | Same |
| Reagents | The e-CHECK(XE)® control consists of
stabilized human and animal blood. This
product is provided in three levels that
vary in concentration by parameters.
Vials are labeled L1, L2, and L3. | 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. |
| Storage
Conditions | 2 - 8°C | Same |
.
2
Discussion of Tests and Test Results:
DIScussion of Tests and Test Nesults.
The following studies were conducted to establish performance of XN CHECK™ and teach of the The following studies were vondation to libre in performance. All testing showed that were Open Phar Stablity, Olosca Vial Stablity, and President to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Conclusions brawn i ronr rests.
Study results show XN CHECK™ to be consistently consistently equivals and effective Study Tesulis Show XN OFEON - to be re product dating. XN CHECK™ is a safe and effective product, which fulfills its intended use when used as instructions for Use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 19 2012
Streck c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
Re: K120742
Trade/Device Name: XN-CHECK™ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK 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 for ass barber 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 I ou may arous 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 If your device is classified (boo are ) Existing major regulations affecting your device can be four di 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 r toase be devices and internination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Or ice related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Ms. Deborah Kipp
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
mana in 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
5
Indication for Use Form
510(k) Number (if known): K120742
Device Name: XN CHECK™
Indications For Use:
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:
RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (1%), MONO(%), EQ(%), BASO(%), IG(%), NEUT#(103)pL), LYMPH#(103/pL), MONO# (10°/μL), MONO®(L), BASO#(10³), 1G#(10³/pL), IPF(%), RET#(10º/pL), RET%, IRF%, RET-HE(pg), NRBC#(103/µL), NRBC% (/100 WBC)
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)
Division Sign-Off
Office of In Vitro Diagnostie Device Evaluation and Safety
510(k) K120742
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