(140 days)
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No
The document describes a calibration material for a hematology analyzer, consisting of stabilized blood components. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies focus on stability and precision, typical for a calibration product.
No
This device is a calibrator used for laboratory analyzers, not a device intended for treating a disease or condition.
No
Explanation: The device is a "calibration and calibration verification" product for analyzers, not a diagnostic device itself. Its purpose is to ensure the accuracy of other diagnostic instruments.
No
The device description explicitly states that the device "contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium," indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the "calibration and calibration verification of Sysmex XN series analyzers." These analyzers are used to perform diagnostic tests on biological samples (blood, in this case, as indicated by the components). Calibration and verification are essential steps in ensuring the accuracy and reliability of diagnostic testing.
- Device Description: The device contains "stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium." These are biological components used to mimic patient samples for the purpose of calibrating and verifying the performance of a diagnostic instrument.
- Performance Studies: The summary of performance studies mentions evaluating "product performance claims" and establishing that the device 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 (K120747) and the name "XN CAL™ PF" 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.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the combination of its intended use in calibrating diagnostic analyzers, its composition of biological components, and the context of regulatory submission (implied by the predicate device) clearly indicates that it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include:
PLT-F (10^3/ uL)
Product codes
KRX
Device Description
XN CAL PF contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium.
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
Not Found
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
To substantiate the product performance claims for XN CAL PF, 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 PF 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
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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 Manager 7002 South 109th Street Lavista, Nebraska 68128
Re: K141955
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: October 24, 2014 Received: October 27, 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
1
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/ResourcesforYou/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.
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)
K141955
Device Name XN CAL PF
Indications for Use (Describe) XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20. XN-21) analyzers. Assayed parameters include:
PLT-F (10^3/ uL)
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: | Deborah Kipp, Regulatory Affairs Manager |
| Address: | 7002 South 109th Street; La Vista, NE 68128 |
| Phone: | 402-537-5215 |
| Fax: | 402-537-5317 |
| Date Prepared: | April 18, 2014 |
| Names | |
Trade Name: Common Name: Classification Name: Product Code: Panel:
XN CAL™ PF Assayed Hematology Calibrator Calibrator for Cell Indices (864.8150) KRX Hematology
Predicate Device:
XN CAL™ PF (K120747)
Intended Use:
XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include:
PLT-F (103/ µL)
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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 PF. The predicate device is shown in the "Comparison to Predicate Device" section.
Comparison to Predicate Device
| | XN CAL™ PF (K120747)-Predicate
Device | XN CAL™ PF -Candidate Device | Same or Differences |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended
Use
Statement | 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/μL) | XN CAL PF is used for calibration and
calibration verification of Sysmex XN series
(XN-10, XN-11, XN-20, XN-21) analyzers.
The assayed parameter is:
PLT-F (103/μL) | 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 PF contains the following:
stabilized red blood cell component(s),
and stabilized platelet component(s) in a
preservative medium. | XN CAL PF contains the following: stabilized
red blood cell component(s), and stabilized
platelet 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 PF, 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 PF 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 PF to be consistently reproducible, substantially equivalent to the predicate products, and stable for 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.