(296 days)
Not Found
No
The device description and performance studies focus on the stability and precision of a calibration material, not on any analytical or interpretive functions that would typically involve AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No
The device is described as a calibrator for laboratory analyzers, not a device used for treating patients.
No
The device, XN CAL, is used for the calibration and calibration verification of Sysmex XN series analyzers. It is a control material used to ensure the accuracy of other diagnostic devices, rather than being a diagnostic device itself that directly diagnoses or detects disease in patients.
No
The device description explicitly states that XN CAL contains physical components (stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in a preservative medium), indicating 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 clearly states that XN CAL is used for the calibration and calibration verification of Sysmex XN series analyzers. These analyzers are used to measure parameters in blood samples (WBC, RBC, HGB, HCT, PLT, RET), which are in vitro diagnostic tests.
- Device Description: The device contains stabilized blood cell components in a preservative medium. These components are used to mimic human blood samples for the purpose of calibrating and verifying the performance of the analyzers.
- Purpose: The purpose of calibration and calibration verification is to ensure the accuracy and reliability of the diagnostic results obtained from the analyzers when testing patient samples. This is a crucial step in the in vitro diagnostic process.
Therefore, based on its intended use and description, XN CAL fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)
Product codes
KRX
Device Description
XN CAL 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.
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
Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability. The resultant data set established that XN CAL 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 instructions for Use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8150 Calibrator for cell indices.
(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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 contains the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, unified image. The profiles are facing to the right and are meant to represent the department's commitment to health and 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: K160585
Trade/Device Name: XN CAL Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX Dated: December 15, 2016 Received: December 16, 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 Part 801); medical device reporting (reporting of medical
1
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 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 yours,
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 CAL
Indications for Use (Describe)
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:
WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)
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: | Deborah Kipp, Regulatory Affairs Manager
7002 South 109th Street; La Vista, NE 68128
402-537-5215 |
| Fax: | 402-537-5317 |
| Date Prepared: | Revised: October 17, 2016 |
| Names | |
Trade Name: Common Name: Classification Name: Product Code: Panel:
XN CAL™ Assayed Hematology Calibrator Calibrator for Cell Indices (864.8150) KRX Hematology
Predicate Device:
XN CAL™ (K141962)
Intended Use:
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:
WBC (103/pL), RBC (10°/µL), HGB (g/dL), HCT (%), PLT (103/ µL), and RET (%)
4
Description:
Per the FDA guidance document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)), a predicate device was selected in order to demonstrate substantial equivalence for XN CAL. The comparison to the "Comparison to Predicate Device" section.
Comparison to Predicate Device
| XN CAL™ (K141962)-Predicate Device | XN CAL™- Candidate Device | Same or Differences | |
|---|---|---|---|
| Intended | |||
| Use | |||
| Statement | XN CAL is used for the calibration and | ||
| calibration verification of Sysmex | |||
| XN series (XN-10, XN-11, XN-20, XN- |
- analyzers. Assayed parameters
include:
WBC ( $10^3$ /µL), RBC ( $10^6$ /µL),
HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), and
RET (%) | XN CAL is used for the calibration and
calibration verification of Sysmex
XN series (XN-10, XN-11, XN-20, XN-21,
XN-L) analyzers. Assayed parameters
include:
WBC ( $10^3$ /μL), RBC ( $10^6$ /μL),
HGB (g/dL), HCT (%), PLT ( $10^3$ / µL), and
RET (%) | Addition of the XN-L
Analyzers. |
| Open Vial
Stability | 4 hours | 4 hours | Same |
| Closed Vial
Stability | 49 days | 35 days | Closed vial stability now
35 days. |
| Reagents | XN CAL 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 CAL 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 CAL, 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 CAL 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 instructions for Use.
Conclusions Drawn From Tests:
Study results show XN CAL to be consistently reproducible, substantially equivalent to the products, and stable for the entire product dating. XN CAL is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.