(140 days)
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No
The document describes a calibration material for a hematology analyzer, not a device that processes data or images using AI/ML. The description focuses on the components of the calibration material and stability studies.
No
This device is a calibrator for laboratory analyzers, not a device used for treating a disease or condition in a patient.
No
Explanation: The device is described as being used for "calibration and calibration verification" of analyzers, not for diagnosing patients. It contains components like stabilized blood cells and is intended to ensure the accuracy of other diagnostic devices (the Sysmex XN series analyzers).
No
The device description explicitly states that XN CAL contains physical components such as stabilized red blood cells, white blood cells, platelets, and nucleated red blood cells in a preservative medium. This indicates it is a physical reagent, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly 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 diagnostic tests performed in vitro (outside the body). Calibration and verification are essential steps to ensure the accuracy of these diagnostic tests.
- Device Description: The device contains stabilized blood cell components in a preservative medium. These components are designed to mimic human blood samples and are used to assess the performance of the diagnostic analyzer.
- Performance Studies: The summary of performance studies mentions "product performance claims" and establishing that the product is "safe and effective for its intended use." This aligns with the regulatory requirements for IVD devices.
- Predicate Device: The mention of a predicate device with a K number (K120745; XN CALTM) strongly suggests that this device is being submitted for regulatory clearance as an IVD, likely through the 510(k) pathway, which requires demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, the primary function of XN CAL is to support the accurate performance of in vitro diagnostic tests performed by the Sysmex XN series analyzers. This clearly places it within 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) analyzers. Assayed parameters include: WBC (10^3/uL), RBC (10^6/uL), HGB (g/dL), HCT (%), PLT (10^3/ uL), and RET (%)
Product codes (comma separated list FDA assigned to the subject device)
KRX
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 CAL, Streck collected product performance data for the following studies Open-Vial Stability, Closed-Vial Stability, and Precision Performance. 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 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.
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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).
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§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
STRECK INC C/O MS. DEBORAH KIPP REGULATORY AFFAIRS MANGER 7002 SOUTH 109TH STREET OMAHA, NE 68128
Re: K141962
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: October 27, 2014 Received: October 28, 2014
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 vours.
Maria M. Chan -S
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
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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) analyzers. Assayed parameters include:
WBC (10^3/uL), RBC (10^6/uL), HGB (g/dL), HCT (%), PLT (10^3/ uL), and RET (%)
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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, Regulatory Affairs Manager
7002 South 109th Street; La Vista, NE 68128
402-537-5215
402-537-5317
April 18, 2014 |
| Names
Trade Name | XN-CALTM |
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™ (K120745)
Intended Use:
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include:
WBC (103/pL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
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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™ (K120745)-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-20) 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) | |||
| 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-11 and | ||
| XN-21 analyzers. | |||
| Open Vial | |||
| Stability | 4 hours | 4 hours | Same |
| Closed Vial | |||
| Stability | 35 days | 49 days | Extension of Closed Vial |
| Stability Dating to 49 | |||
| 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 |
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Discussion of Tests and Test Results:
To substantiate the product performance claims for XN CAL, Streck collected product performance data for the following studies Open-Vial Stability, Closed-Vial Stability, and Precision Performance. 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 instructed in the 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.