(296 days)
Not Found
No
The device description and performance studies focus on the stability and precision of a control material for laboratory analyzers, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in-vitro diagnostic control used for calibration and quality control of laboratory analyzers, not for treating patients.
No
Explanation: The device is described as an "in-vitro diagnostic, two level, control" for Sysmex XN series analyzers, used for "control and calibration." It contains stabilized blood components and is intended to verify the performance of the analyzers. It is not used to diagnose a patient's condition.
No
The device description explicitly states that XN CHECK™ BF is an in-vitro diagnostic control containing stabilized red and white blood cell components in a preservative medium within plastic vials. This indicates a physical, biological product, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Device Description" section clearly states: "XN CHECK™ BF is an in-vitro diagnostic, two level, control."
- Intended Use: The "Intended Use / Indications for Use" describes its use for "control and calibration of Sysmex XN series... analyzers," which are used for analyzing biological samples (blood, in this case, based on the parameters listed). This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description of the contents (stabilized red and white blood cell components) and packaging (vials) further supports its use as a reagent or control for laboratory testing.
N/A
Intended Use / Indications for Use
XN CHECK BF is used for control and calibration 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: WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
XN CHECK™ BF is an in-vitro diagnostic, two level, control reagent. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium polypropylene plastic vials with screw caps with a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / 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
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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: Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability. 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.)
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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.
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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, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
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: K160588
Trade/Device Name: XN CHECK BFTM Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 17, 2016 Received: October 18, 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
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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 addresshttp://www.fda.gov/MedicalDevicesforYou /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/ 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)
Device Name XN CHECK BF
Indications for Use (Describe)
XN CHECK BF is used for control and calibration 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:
WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)
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, Requlatory Affairs Manager
7002 South 109" Street; La Vista, NE 68128
402-537-5215
402-537-5317
Revised: October 14, 2016 |
| Names | |
Trade Name: Common Name: Classification Name: Product Code: Panel:
XN CHECK™ BF Assayed Hematology Control Hematology quality control mixture (864.8625) JPK Hematology
Predicate Device:
XN CHECK™ BF (K141957)
Intended Use:
XN CHECK BF is used for control and calibration 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:
WBC-BF (103/μL), RBC-BF (108/μL), MN# (103/μL), PMN# (103/μL), MN%, PMN%, TC-BF# (103/µL)
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Description:
XN CHECK™ BF is an in-vitro diagnostic, two level, hent contains the following: stabilized ted blood cell component(s) and stablized white blood cell component(s) in a preservative medium polypropylene plastic vials with screw caps with a 3 m fill. The vials will be packaged in (4) welled vacum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.
Comparison to Predicate Device:
| XN-CHECK BF (K141957) - Predicate Device | XN CHECKTM 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-11, XN-20, XN-21) | |||
| analyzers. It is not, however, intended | |||
| for actual calibration of these analyzers. | |||
| Assayed parameters include: | XN CHECK BF 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: | Addition of XN-L Analyzer | ||
| WBC-BF (103/µl), RBC-BF (106/ µl), MN# | |||
| (103/µl), PMN# (103/µl), MN% (%), | |||
| PMN% (%), TC-BF# (103/µl) | WBC-BF (103/µL), RBC-BF (106/µL), MN# | ||
| (103/µL), PMN# (103/µL), MN%, | |||
| PMN%, TC-BF# (103/µL) | |||
| 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: Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability. 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.