(21 days)
Not Found
No
The summary describes a hematology control reagent used to monitor the performance of hematology analyzers. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML within the control itself. The focus is on the stability and performance of the reagent as a control material.
No.
This device is an in vitro diagnostic control material used to monitor the performance of hematology analyzers, not to treat a condition or disease.
No
The device is a control used to monitor the performance of hematology analyzers, not a device that diagnoses a patient's condition.
No
The device description clearly states it is an "in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro Diagnostic Use Only".
- Device Description: The "Device Description" further reinforces this by stating it is an "in vitro diagnostic reagent".
- Function: The device is designed to monitor values on hematology analyzers, which are used for diagnostic testing of patient samples.
- Predicate Device: The predicate device listed (K042094 R&D Systems CBC-XE Hematology Control) is also a hematology control, which are typically classified as IVDs.
N/A
Intended Use / Indications for Use
XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers. For in vitro Diagnostic Use Only
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
The R&D Systems XERet Hematology Control is an in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing of 3 validation lots has shown the R&D XERet Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The XERet Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 85 days (closed vial) and 15 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, 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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K10050
January 7, 2010
510(k) Summary
JAN 2 9 2010
Submitter Information
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Nancy Ring Phone: 612-656-4533 Fax: 612-379-6580 Date Prepared: 1/7/2010
Device Information
Proprietary Name: Common Name: Classification Classification Name: Product Code: Device Class: Panel:
XERet Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture ТЫК . Hematology (81)
Predicate Device
R&D Systems CBC-XE Hematology Control, (K042094) manufactured by R&D Systems, Inc. 614 McKinlev Place N.E., Minneapolis, MN 55413.
Description of Device
The R&D Systems XERet Hematology Control is an in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
Intended Use:
XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers.
Technological Comparison to Predicate
The new device has the same technological characteristics as the legally marketed predicate device. Both are used to perform quality control assays and both products are used to monitor values obtained from Sysmex® hematology analyzers. The predicate device is assayed for WBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, MPV, NEUT #, LYMPH #, MONO #, EO #, BASO #, NEUT%, MONO%, LYMPH%, E0%, BASO%, NRBC%, NRBC%, RBC, RET%, RET#, IRF, and RET-HE, whereas the R&D XERet Hematology Control is assaved for only RBC. RET%, RET%, and IRF parameters.
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Summary of Performance Data
Laboratory testing of 3 validation lots has shown the R&D XERet Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The XERet Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 85 days (closed vial) and 15 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Substantial Equivalence Conclusion
The data demonstrate that the R&D XERet Hematology Control is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure composed of three curved lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
R & D Systems, Inc. c/o Ms. Nancy Ring Sr. OA/RA Specialist 614 McKinley Place, N.E. Minneapolis, MN 55413
JAN 2 9 2010
Re: K100050
Trade/Device Name: R&D Systems CBC-XE Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: January 7, 2010 Received: January 8, 2010
Dear Ms. Ring:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Ms. Nancy Ring
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 Diagnostic Device Evaluation and Safety 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,
Anani M. Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K |00050
Device Name: R&D XERet Hematology Control
Indications for Use:
R&D XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers.
For in vitro Diagnostic Use Only
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100050
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