(50 days)
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No
The document describes a hematology control, which is a substance used to verify the accuracy of laboratory instruments. 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 precision of the control substance itself.
No.
This device is a control designed to monitor the accuracy and precision of hematology instruments, not to directly treat a medical condition or ailment.
No
Explanation: The device is a whole blood control used to monitor the accuracy and precision of hematology instruments, not to diagnose a patient's condition.
No
The device is described as an "assayed whole blood control," which is a physical substance used for quality control in hematology instruments. This is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic device that analyzes blood.
- Device Description: It's described as an "assayed whole blood control designed to monitor values on multi-parameter hematology cell counters." This further reinforces its role in the in vitro diagnostic process.
- Performance Studies: The description of performance studies mentions "laboratory testing" and "precision," which are typical evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K970331 R&D Systems CBC-4K Hematology Control) is common in regulatory submissions for IVD devices, demonstrating substantial equivalence to a previously cleared device.
While it doesn't directly diagnose a disease in a patient, it is a critical component in ensuring the accuracy and reliability of a diagnostic instrument (the hematology analyzer) that does perform diagnostic testing on patient samples. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.
Product codes
JPK
Device Description
This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.
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
Laboratory testing of 3 validation lots has shown R&D CBC-4K Plus Retics Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-4K Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product, R&D CBC-4K Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. Expiriation dating has been established at 75 days (closed vial) and 8 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Key Metrics
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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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JUL 1 2 2005
510(k) Special Summary R&D Systems, Inc. CBC-4K Plus Retics Hematology Control
| Date of Summary: | June 29, 2005 |
|---|---|
| Company Name: | R&D Systems, Inc. |
| 614 McKinley Place N.E. | |
| Minneapolis, MN 55413 | |
| Contact name: | Ralph E. Hogancamp |
| 612-656-4413, FAX 612-379-6580 | |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D CBC-4K Plus Retics Hematolog |
| Control | |
| CFR section: | 864.8625 Hematology quality control |
| mixture. |
Predicate Device: R&D Systems CBC-4K Hematology Control, K970331 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413
Description: This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.
Intended use: R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.
Comparison: Both products are used to monitor CELL-DYN® hematology instruments. The R&D CBC-4K Plus Retics added new parameters.
Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-4K Plus Retics Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-4K Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product, R&D CBC-4K Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. Expiriation dating has been established at 75 days (closed vial) and 8 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D CBC-4K Plus Retics Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
JUL 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ralph E. Hogancamp Regulatory Affairs Specialist R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
Re: K051339
Trade/Device Name: R&D CBC-4K Plus Retics Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: June 29, 2005 Received: June30, 2005
Dear Mr. Hogancamp:
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 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobetz Beckerh
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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Indications for Use
510(k) Number (if known): K051339
Device Name: R&D CBC-4K Plus Retics Hematology Control
Indications for Use:
R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.
Prescription Use X________AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO USE ANOTHER PAGE IF NEEDED)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K05133 510(k)________________________________________________________________________________________________________________________________________________________________________
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