(224 days)
Not Found
No
The device is a calibration material for a hematology analyzer and does not describe any software or algorithms that would incorporate AI/ML.
No.
Explanation: The device is described as an "in-vitro diagnostic product" used for "calibration and calibration verification of Sysmex XN series analyzers," primarily for measuring PLT-F. It does not directly treat or diagnose medical conditions in a patient, which distinguishes it from a therapeutic device.
No
The device is used for calibration and calibration verification of analyzers, not for diagnosing patient conditions itself.
No
The device description explicitly states it contains physical components: "stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium," packaged in "polypropylene 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 document explicitly states that "XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers." Calibration and calibration verification of laboratory analyzers used to test biological samples are core functions of IVD products.
- Device Description: The description states that "XN CAL™ PF is an in-vitro diagnostic product." This is a direct declaration of its IVD status. It also describes the components as "stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium," which are typical components of IVD calibrators.
- Predicate Device: The document lists a predicate device, "K083200; X-CAL™," which is also a calibrator for hematology analyzers. This further supports its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes within the IVD framework.
Therefore, based on the provided information, XN CAL™ PF is clearly identified and described as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is: PLT-F (103/pL)
Product codes
KRX
Device Description
XN CAL™ PF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), and stabilized platelet 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 / 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
The following studies were conducted to establish performance of XN CAL™ PF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that were open fiar Stablity, eloces vilusible, substantially equivalent to the predicate product and stable for the shelf life claimed.
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.
0
KI205747
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 | OCT 2 2 2012 |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------|
| 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™ PF
Assayed Hematology Calibrator
Calibrator for Cell Indices (KRX-864.8150) | |
| Predicate Device: | X-CAL™ (K083200) Manufactured by Streck | |
| | | |
Description:
XN CAL™ PF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), and stabilized platelet 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 / assay sheet. The product must be stored at 2 - 8° C.
Intended Use:
XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is:
PLT-F (103/pL)
1
Comparison to Predicate Device:
| X-CALTM-K083200 | XN CALTM PF | |
|---|---|---|
| (Predicate Product) | ||
| Intended Use | ||
| Statement | X-CALTM is used to calibrate and | |
| verify calibration of Sysmex | ||
| hematology analyzers. Refer to | ||
| product assay sheet. | XN CALTM PF is used for calibration | |
| and calibration verification of | ||
| Sysmex XN series (XN-10, XN-20) | ||
| analyzers. The assayed parameter is: | ||
| PLT-F (103/μL) | ||
| Open Vial Stability | 24 hours | 4 hours |
| Closed Vial | ||
| Stability | 35 days | Same |
| Reagents | X-CALTM 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 CALTM PF contains the following: | |
| stabilized red blood cell component(s), | ||
| and stabilized platelet component(s) in | ||
| a preservative medium. | ||
| Storage | ||
| Conditions | 2 - 8°C | Same |
Discussion of Tests and Test Results:
Discussion of rests and Test Resulter
The following studies were conducted to establish performance of XN CAL™ PF. The tests conducted were Open-Vial Stability, Closed-Vial Stability, and Precision Performance. All testing showed that were open fiar Stablity, eloces vilusible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Outlations show XN CAL™ PF to be consistently reproducible, substantially equivalent to the Study Tesults Snow XN Orte - The entire product dating. XN CAL™ PF is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.
2
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 outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
10903 New Hampshire Avenue Silver Spring, MD 20993
Streck
c/o Ms. Deborah S. Kipp Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
Re: K120747
Trade/Device Name: XN-CAL™ PF 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
OCT 22 2012
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.
Maria M Clan
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): K120747
Device Name: XN CAL™ PF
Indications For Use:
XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is:
PLT-F (103/pL)
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)
Division Sign Off/
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120747
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