(221 days)
Not Found
No
The device description and performance studies focus on the stability and reproducibility of a calibration material for a hematology analyzer, with no mention of AI or ML algorithms.
No
The device is described as an "in-vitro diagnostic product" used for the calibration and calibration verification of analyzers, not for treating diseases or conditions.
No
XN CAL is a calibration and calibration verification product for analyzers, not a device that directly diagnoses patient conditions.
No
The device description explicitly states it contains physical components such as stabilized blood cell components, a preservative medium, and is 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/Indications for Use: The description explicitly states that XN CAL is used for the "calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers." These analyzers are used to measure parameters in blood samples (WBC, RBC, HGB, HCT, PLT, RET), which are diagnostic tests performed in vitro (outside the body).
- Device Description: The description clearly states that "XN CAL™ is an in-vitro diagnostic product." It also describes the components as "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." These are biological components used to calibrate instruments that analyze biological samples.
The definition of an In Vitro Diagnostic (IVD) product is a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. Calibration materials for diagnostic instruments fall under this definition as they are essential for ensuring the accuracy and reliability of the diagnostic tests performed by those instruments.
N/A
Intended Use / Indications for Use
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. Assayed parameters include: WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
Product codes
KRX
Device Description
XN CAL™ 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 (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. The product must be stored at 2 - 8° C.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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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
The following studies were conducted to establish performance of XN CAL™. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CAL™ 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)
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.
0
16120745
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 | OCT 1 9 201 |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------|
| 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 CAL TM
Assaved Hematology Calibrator
Calibrator for Cell Indices (KRX-864.8150) | |
| Predicate Device: | X-CAL™ (K083200) Manufactured by Streck | |
| Description: | | |
XN CAL™ 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 (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. The product must be stored at 2 - 8° C.
Intended Use:
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. Assayed parameters include:
WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
1
Comparison to Predicate Device:
| | X-CALTM-K083200
(Predicate Product) | XN CALTM |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | X-CAL is used to calibrate and
verify calibration of Sysmex
hematology analyzers. Refer to
product assay sheet. | XN CAL is used for the calibration and
calibration verification of Sysmex
XN series (XN-10, XN-20) analyzers.
Assayed parameters include:
WBC (103/μL), RBC (106/μL),
HGB (g/dL), HCT (%), PLT (103/ μL),
and RET (%) |
| Open Vial Stability | 24 hours | 4 hours |
| Closed Vial
Stability | 35 days | Same |
| Reagents | X-CAL is composed of a mixture of
stabilized human and animal blood
cells. The cells are suspended in a
solution containing biological salts
and anti-microbial preservatives. | 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. |
| Storage
Conditions | 2 - 8°C | Same |
Discussion of Tests and Test Results:
The following studies were conducted to establish performance of XN CAL™. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that XN CAL™ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Study results show XN CAL™ to be consistently reproducible, substantially equivalent to the predicate 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 product package insert.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
10903 New Hampshire Avenue Silver Spring, MD 20993
Streck c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
Re: K120745
Trade/Device Name: XN-CALTM Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX 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
OCT 19 2012
3
Page 2 – Ms. Deborah Kipp
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualisms of brovisions (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,
Maria 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 120745
Device Name: XN CAL™
Indications For Use:
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. Assayed parameters include:
WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
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)
Serk R. Li
ion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120745
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