(20 days)
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No
The document describes a hematology control material used to monitor the performance of instruments, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is an in vitro diagnostic control used to monitor the performance of hematology analyzers, not to treat patients.
No
The device is a control material used to monitor the performance of diagnostic tests, not a diagnostic device itself.
No
The device description clearly states it is an in vitro diagnostic control composed of physical materials (human erythrocytes, simulated leukocytes, mammalian platelets, plasma-like fluid, preservatives). It is a physical control used to monitor the performance of hematology analyzers, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro Diagnostic Use Only". It also describes its use in monitoring the performance of diagnostic tests (hematology instruments).
- Device Description: Describes the control as an "in vitro diagnostic control".
- Summary of Performance Studies: Discusses laboratory testing and validation, which is typical for IVD devices.
N/A
Intended Use / Indications for Use
The CBC-5D Plus Retics is a control designed to monitor values on Coulter hematology analyzers. Refer to assay sheet for specific instrument models.
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The CBC-5D Plus Retics Hematology Control is designed to document and monitor values obtained from Coulter® hematology instruments.
For in vitro Diagnostic Use Only
Product codes
JPK
Device Description
CBC-5D Plus Retics is an in vitro diagnostic control composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of Coulter® hematology analyzers. 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 CBC-5D Plus Retics Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The CBC-5D Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. The CBC-5D Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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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AUG 2 0 2007
510(k) Summary
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: 7/30/07
Device Information
Proprietary Name: CBC-5D Plus Retics Hematology Control Common Name: Hematology Controls Classification 21 CFR 864.8625 Classification Name: Hematology Quality Control Mixture Product Code: JPK Device Class: Panel: Hematology (81)
Predicate Device
R&D Systems CBC-5D Hematology Control, (K983032) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.
Description of Device
CBC-5D Plus Retics is an in vitro diagnostic control composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of Coulter® hematology analyzers. It is sampled in the same manner as a patient specimen.
Intended Use:
The CBC-5D Plus Retics is a control designed to monitor values on Coulter hematology analyzers. Refer to assay sheet for specific instrument models.
Technological Comparison to Predicate
The new device has the same technological characteristics as the legally marketed predicate device. Both products are used to monitor Coulter® hematology instruments. Both are used to perform quality controls assays. The CBC-5D Plus Retics Hematology Control has an additional parameter.
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Summary of Performance Data
Laboratory testing of 3 validation lots has shown the CBC-5D Plus Retics Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The CBC-5D Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. The CBC-5D Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. 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 demonstrates that the CBC-5D Plus Retics Hematology Control is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 0 2007
Nancy Ring R & D Systems, Inc. 614 McKinley Place, NE Minneapolis, Minnesota 55413
Re: K072096
Trade/Device Name: CBC-5D Plus Retics Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: July 30, 2007 Received: July 31, 2007
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice 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
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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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
· Sincerely yours,
Robert A. Becker
Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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July 30, 2007
Indications for Use
K072096 510(k) Number (if known): __
Device Name: CBC-5D Plus Retics Hematology Control
Indications for Use:
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The CBC-5D Plus Retics Hematology Control is designed to document and monitor values obtained from Coulter® hematology instruments.
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)
Dorochine Bautista
Division Sign-Off
Division
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072096
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