(221 days)
Not Found
No
The device description and intended use indicate it is a control and calibration verification product for laboratory analyzers, not a software or analytical tool that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The "Intended Use" states that the device is for "control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers" and is "not, however, intended for actual calibration of these analyzers." This indicates it's for quality control and verification of diagnostic equipment, not for treating any medical condition.
No
This device is a control and calibration verification product for analyzers, not a diagnostic device itself. Its labeling explicitly states it is "not ... intended for actual calibration of these analyzers" and its purpose is to verify the performance of other diagnostic instruments.
No
The device description explicitly states it is an "in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium." This indicates it is a physical reagent, 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 BF is used for "control and calibration verification of Sysmex XN series... analyzers." This indicates it's used to assess the performance of diagnostic equipment.
- Device Description: The "Device Description" section clearly states that "XN CHECK™ BF is an in-vitro diagnostic product".
- Components: The description mentions it contains "stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium." These are biological components used for testing purposes.
- Storage: The requirement to store the product at 2 - 8° C is typical for biological reagents used in IVD testing.
- Performance Studies: The document describes performance studies conducted to establish the product's reliability, which is a standard requirement for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K053362; Cell-Chex Auto) indicates that this device is being compared to a previously cleared IVD device.
All of these points strongly support the classification of XN CHECK BF 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-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)
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
XN CHECK™ BF is an in-vitro diagnostic product that contains 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 screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / 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™ BF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CHECK™ BF is consistently reproducible, substantially equivalent 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.
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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OCT 1 9 2012
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
| ------------------- | ------------------------------------------------------ |
|---|
Official Correspondent: Deborah Kipp, Quality Assurance Coordinator (402)537-5215
coordinates
Date Prepared: Revised-September 21, 2012
Name of Device: Trade Name: XN CHECK™ BF Common Name: Assayed Hematology Control Classification Name: Hematology Quality Control Mixture-(JPK-864.8625)
Cell-Chex Auto-K053362
Predicate Device:
Description:
XN CHECK™ BF is an in-vitro diagnostic product that contains 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 screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.
Intended Use:
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 (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)
1
Comparison to Predicate Device:
| Cell-Chex™ Auto-K053362 | XN CHECK™ BF | |
|---|---|---|
| (Predicate Product) | ||
| Intended Use | ||
| Statement | Cell-Chex Auto is an assayed whole | |
| blood control for evaluating the | ||
| accuracy and precision of | ||
| hematology instruments that | ||
| measure blood cell counts in patient | ||
| body fluid samples. | 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) | ||
| Open Vial Stability | 30 days | Same |
| Closed Vial | ||
| Stability | 75 days | 84 days |
| Reagents | Cell-Chex™ Auto contains | |
| stabilized human red blood cells | ||
| and white blood cells 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. | ||
| Storage | ||
| Conditions | 2 - 10°C | 2 - 8°C |
Discussion of Tests and Test Results:
The following studies were conducted to establish performance of XN CHECK™ BF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CHECK™ BF is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
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 instructions for Use.
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 19 2012
Streck c/o Ms. Deborah S. Kipp Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
Re: K120744
Trade/Device Name: XN-CHECK™ BF 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 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.
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
3
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.
Monai M 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
4
Indication for Use Form
510(k) Number (if known): K 1207 44
Device Name: XN CHECK™ BF
Indications For Use:
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 (108/μl), MN# (10³/μl), PMN# (10³/μl), MN% (%), PMN% (%), TC-BF# (103/μl)
Prescription Use X (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 Diagnostic Device Evaluation and Safety
510(k) K120744
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