(21 days)
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
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.
The provided text describes the acceptance criteria and the study for the R&D XERet Hematology Control. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within range over the life of the product | Passed this criterion. |
| Substantial equivalence in performance, precision, and stability to the predicate device | Demonstrated substantial equivalence in these aspects. |
| Closed vial expiration dating | Established at 85 days when stored at 2 - 8° C. |
| Open vial expiration dating | Established at 15 days when stored at 2 - 8° C and handled per instructions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Laboratory testing of 3 validation lots" was performed.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Minneapolis, MN, USA) and the submission to the FDA, it's highly likely the data is from the USA and is prospective as it's part of a validation study for a new product.
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. The "ground truth" for a hematology control typically refers to the expected range of values for given parameters, which are often established through rigorous internal testing and statistical analysis by the manufacturer, rather than by external expert consensus in the same way, for example, a diagnostic image might be.
4. Adjudication Method for the Test Set
- This information is not explicitly stated. Given the nature of a hematology control (monitoring quantitative values), adjudication by multiple experts in the traditional sense (e.g., 2+1, 3+1) is typically not applicable. The performance is assessed against predefined statistical ranges and comparisons to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved, such as medical imaging. The R&D XERet Hematology Control is an in vitro diagnostic reagent used to monitor automated hematology analyzers, not directly interpreted by human readers in the same context as an MRMC study.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, performance evaluation was done for the device itself. The device is a "control" for an analyzer, so its "standalone" performance relates to its ability to maintain stable and accurate assay values over time (stability, precision) and perform comparably to its predicate. The text states: "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."
7. The Type of Ground Truth Used
- The ground truth for a hematology control is established by determining its assayed values and expected ranges for the measured parameters (RBC, RET%, RET#, IRF). This is typically done through a process of:
- Manufacturer's internal testing: Extensive testing of multiple lots to establish mean values and standard deviations for each parameter.
- Comparison to a predicate device: The study explicitly mentions "substantial equivalence... to the predicate device," implying the predicate's established performance serves as a reference point for acceptable ranges.
- Statistical analysis: To define the "range" within which the control should perform.
- Therefore, the ground truth is primarily based on established reference values/ranges derived from the manufacturer's testing and comparison to a legally marketed predicate device.
8. The Sample Size for the Training Set
- The document does not provide information regarding a training set. Hematology controls are manufactured to specific specifications and then
validated; they are not "trained" in the typical machine learning sense. The "3 validation lots" are part of the testing/validation phase.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable or mentioned for this device, a method for establishing its ground truth is also not provided.
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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
Page 1 of 1
§ 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.