(107 days)
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No
The document describes a hematology control reagent, which is a stabilized material used to monitor the performance of hematology analyzers. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The focus is on the stability and performance of the control material itself.
No
This device is an in vitro diagnostic control material used to monitor the performance of hematology analyzers, not to treat a disease or condition.
No
The device is a control material used to monitor the performance of diagnostic analyzers, not a diagnostic device itself. The "Intended Use / Indications for Use" states it is "designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers," and the "Device Description" elaborates that it "provides a means of monitoring reticulocyte counting methods." It is "For in vitro Diagnostic Use Only," which refers to its use within the context of in vitro diagnostics, not that it is a diagnostic device itself.
No
The device is described as an in vitro diagnostic reagent composed of human blood in a plasma-like fluid, clearly indicating it is a physical substance and 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 description states it is an "in vitro diagnostic reagent" and is used for "monitoring reticulocyte counting methods," which are diagnostic procedures performed outside the body.
- Purpose: The device is designed to monitor the performance of hematology analyzers used for diagnostic testing (measuring RET%, RET#, IRF, and MRV values).
These points strongly indicate that the device is intended for use in a laboratory setting to aid in the diagnosis or monitoring of a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
For in vitro Diagnostic Use Only.
Product codes
JYK
Device Description
The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human 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
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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)
Laboratory testing of 3 validation lots has shown the R&D 5D Retic Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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R & D Systems, Inc. R&D 5D Retic Hematology Control June 26, 2013
510(k) Summarv
JUL 2 4 2013
Submitter Information
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Ambreen Athar Phone: 612-379-2956 (ext. 4136) Fax: 612-379-6580 Date Prepared: June 26, 2013
Device Information
Proprietary Name: Common Name: Classification Classification Name: Product Code: Device Class: Panel:
R&D 5D Retic Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture льк 11 Hematology (81)
Unmodified Predicate Device
R&D Systems CBC-5D Plus Retics Hematology Control, (K072096) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.
Description of Device
The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human 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:
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
Technological Comparison to Predicate
The modified 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 Coulter® hematology analyzers. The predicate device is assaved 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%, and IRF whereas the R&D 5D Retic Hematology Control is assayed for only RET%, RET#, IRF, and MRV parameters.
1
Summary of Performance Data
Laboratory testing of 3 validation lots has shown the R&D 5D Retic Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 105 days (closed vial) and 14 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 5D Retic 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
R&D SYSTEMS, INC. c/o MS. AMBREEN ATHAR QA/RA SPECIALIST 614 MCKINLEY PLACE, N.E. MINNEAPOLIS MN 55413
Re: K130962
Trade/Device Name: R&D 5D Retic Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: June 26, 2013 Received: July 12, 2013
Dear Ms. Athar:
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 (sec above) into cither 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the
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Page 2-Ms. Ambreen Athar
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 regulations (21 CFR Parts 801 and 809), please contact 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/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/ReportalProblem/default.htm for the CDRI-1'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/MedicalDevices/Resourcesfor You/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): K130962
Device Name: R&D 5D Retic Hematology Control
Indications for Use:
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
For in vitro Diagnostic Use Only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Leonthena R. Carrington -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K130962