(140 days)
Not Found
No
The device description and performance studies focus on the stability and precision of a control and calibration verification product for blood analyzers, with no mention of AI or ML technologies.
No
The device is described as an "in-vitro diagnostic product" used for control and calibration verification of analyzers, not for direct treatment or diagnosis of a patient's medical condition. It does not exert any therapeutic effect on the body.
No
Explanation: The device, XN CHECK BF, is described as an "in-vitro diagnostic product" used for "control and calibration verification" of analyzers, not for diagnosing medical conditions in patients. Its purpose is to ensure the accuracy of diagnostic instruments rather than performing diagnostics themselves.
No
The device description explicitly states that the product is an in-vitro diagnostic product containing stabilized red and white blood cell components in a preservative medium, packaged in vials. This indicates a physical, non-software component.
Yes, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "XN CHECK™ BF is an in-vitro diagnostic product..."
- Intended Use: The "Intended Use / Indications for Use" describes its use for "control and calibration verification of Sysmex XN series... analyzers." These analyzers are used to perform diagnostic tests on biological samples (blood).
- Components: The device contains "stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium," which are components used in the process of analyzing blood samples.
Therefore, based on the provided text, XN CHECK BF is clearly identified as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
XN CHECK BF 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: WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)
Product codes
JPK
Device Description
XN CHECK™ BF is an in-vitro diagnostic product the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are 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)
To substantiate the product performance claims for XN CHECK BF, 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 BF 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)
XN CHECK™ BF (K120744)
Reference Device(s)
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.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
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 MANAGER 7002 SOUTH 109TH STREET LA VISTA, NE 68128
Re: K141957
Trade/Device Name: XN CHECK™ BF Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: October 24, 2014 Received: October 27, 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 Parts 801 and 809); 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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/ResourcesforYou/Industry/default.htm. 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 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,
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
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Indications for Use
510(k) Number (if known)
Device Name XN CHECK BF
Indications for Use (Describe)
XN CHECK BF 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:
WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)
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)
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)
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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
April 18, 2014 |
| Names | |
| Trade Name: | XN CHECKTM BF |
| Common Name: | Assayed Hematology Control |
| Classification Name: | Hematology quality control mixture (864.8625 |
| Product Code: | JPK |
| Panel: | Hematology |
Predicate Device:
XN CHECK™ BF (K120744)
Intended Use:
XN CHECK BF is used for control and calibration verification of Sysmex XN-10, XN-11, XN-20 XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:
WBC-BF (10³/µl), RBC-BF (10˚/ µl), MN# (10˚µl), PMN# (10˚µl), MN% (%), PMN% (%),
TC-BF# (10˚µl)
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Description:
XN CHECK™ BF is an in-vitro diagnostic product the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are at 2 - 8° C. Comparison to Predicate Device:
| XN-CHECK BF (K120744)-Predicate Device | XN CHECK™ BF -Candidate Device | Same or Differences | |
|---|---|---|---|
| Intended Use | |||
| Statement | XN CHECK BF 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: |
WBC-BF (10³/µl), RBC-BF (10⁶/µl),
MN# (10³/µl), PMN# (10³/µl), MN% (%),
PMN% (%), TC-BF# (10³/µl) | XN CHECK BF 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:
WBC-BF (10³/µl), RBC-BF (10⁶/ μl), MN#
(10³/µl), PMN# (10³/µl), MN% (%), PMN%
(%), TC-BF# (10³/µl) | Addition of the XN-11 and
XN-21 analyzers. |
| Open Vial
Stability | 30 days | 30 days | Same |
| Closed Vial
Stability | 84 days | 84 days | Same |
| Reagents | XN CHECK BF contains the following:
stabilized red blood cell component(s)
and stabilized white blood cell
component(s) in a preservative medium. | XN CHECK BF contains the following:
stabilized red blood cell component(s) and
stabilized white 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 BF, 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 BF 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 BF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. XN CHECK BF is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.