(140 days)
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 (%)
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.
The provided text describes a 510(k) premarket notification for the XN-CAL™ device, a calibrator for cell indices used with Sysmex XN series analyzers. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of formal acceptance criteria with numerical targets. Instead, it discusses the outcomes of various studies to demonstrate the device's performance claims. The key performance claims evaluated are related to stability and precision.
| Acceptance Criteria (Inferred from study types) | Reported Device Performance (Summary from text) |
|---|---|
| Open-Vial Stability: Maintain performance for a specified duration after opening. | XN CAL demonstrated stability for 4 hours (same as predicate device). |
| Closed-Vial Stability: Maintain performance for a specified duration before opening. | XN CAL demonstrated stability for 49 days, an extension from the predicate device's 35 days. 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." |
| Precision Performance: Maintain consistent and reproducible results. | XN CAL was found to be "consistently reproducible." |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily focuses on the regulatory submission and does not provide specific details regarding the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the studies performed. It generally states that "Streck collected product performance data for the following studies: Open-Vial Stability, Closed-Vial Stability, and Precision Performance."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a medical device calibrator, the "ground truth" would likely be established through highly controlled laboratory assays using reference methods, rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation or diagnosis, which is not the primary function of a calibrator for cell indices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI on their performance. The XN-CAL™ is a calibrator, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was done. The document describes studies on "Open-Vial Stability, Closed-Vial Stability, and Precision Performance" for the XN CAL device itself. These studies assess the intrinsic performance of the calibrator, independent of human interaction during the calibration process beyond following the instructions for use. The device's performance as a calibrator is evaluated based on its ability to provide stable and precise values for the specified hematological parameters.
7. Type of Ground Truth Used
The ground truth used for evaluating a calibrator like XN-CAL™ would typically be established through:
- Reference materials/methods: Highly accurate and traceable reference materials or established laboratory methods (e.g., manual cell counts, spectrophotometric hemoglobin measurements) would serve as the "true" values against which the calibrator is manufactured and tested.
- Assayed values: The calibrator itself comes with "assayed values," which are the target values for each parameter determined through rigorous testing against reference methods.
The document implicitly refers to this by stating the product performance data "established that XN CAL is safe and effective for its intended use" and "consistently reproducible."
8. Sample Size for the Training Set
The document does not mention a "training set" because XN-CAL™ is a calibrator, not an AI/machine learning algorithm that requires training data. Its performance is based on its chemical and biological formulation and manufacturing consistency.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of device. The "ground truth" for calibrator values would be established through meticulous laboratory analysis using established reference methods, not through a training process in the AI sense.
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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.
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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: | Streck7002 South 109th StreetLa Vista, NE 68128 |
|---|---|
| Official Correspondent:Address:Phone:Fax:Date Prepared: | Deborah Kipp, Regulatory Affairs Manager7002 South 109th Street; La Vista, NE 68128402-537-5215402-537-5317April 18, 2014 |
| NamesTrade 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 | |
|---|---|---|---|
| IntendedUseStatement | XN CAL is used for the calibration andcalibration verification of SysmexXN 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), andRET (%) | XN CAL is used for the calibration andcalibration verification of SysmexXN 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), andRET (%) | Addition of the XN-11 andXN-21 analyzers. |
| Open VialStability | 4 hours | 4 hours | Same |
| Closed VialStability | 35 days | 49 days | Extension of Closed VialStability Dating to 49days |
| Reagents | XN CAL contains the following: stabilizedred blood cell component(s), stabilizedwhite blood cell component(s), stabilizedplatelet component(s), and stabilizednucleated red blood cell component(s) ina preservative medium. | XN CAL contains the following: stabilized redblood cell component(s), stabilized whiteblood cell component(s), stabilized plateletcomponent(s), and stabilized nucleated redblood cell component(s) in a preservativemedium. | Same |
| StorageConditions | 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.
§ 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.