(39 days)
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No
The document describes a hematology control material used for quality control of laboratory 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 a hematology control used to monitor the performance of hematology analyzers, not to treat a medical condition.
No
Explanation: This device is a hematology control used to monitor the performance of hematology analyzers, not to diagnose medical conditions directly.
No
The device is a hematology control, which is a physical substance used to verify the accuracy of laboratory instruments. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers." This indicates it is used in vitro (outside the body) to assess the performance of instruments that analyze blood components.
- Device Description: The description reinforces its use as a control for hematology analyzers, which are used for in vitro diagnostic testing of blood.
- Predicate Device: The mention of a predicate device (K843962 R&D Systems CBC-3D Hematology Control) which is also a hematology control, further supports its classification as an IVD. Hematology controls are a common type of IVD used to ensure the accuracy of diagnostic tests performed on blood.
While the document doesn't explicitly use the term "IVD," the intended use and description align perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the device is used to ensure the accuracy of the instruments that perform those diagnostic examinations on blood.
N/A
Intended Use / Indications for Use
R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.
R&D CBC-3D + CRP Hematology Control is a tri-level control designed to monitor values on automated and semi-automated impedance type hematology analyzers. Refer to assay sheet for specific instrument models.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
This control is a tri-level control to monitor values on automated and semiautomated impedence type hematology analyzers. It can also be used for manual methods.
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 R&D CBC-3D + CRP Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-3D + CRP Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D CBC-3D + CRP 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 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
0
K\$\alpha$61511
K
JUL 1 0 2006
510(k) Special Summary R&D Systems, Inc. CBC-3D + CRP Hematology Control
| Date of Summary: | May 30, 2006 |
|---|---|
| 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-3D + CRP Hematology Control |
| CFR section: | 864.8625 Hematology quality control |
| mixture. | |
| Device Class: | Class II |
Predicate Device: R&D Systems CBC-3D Hematology Control, K843962 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413
Description: This control is a tri-level control to monitor values on automated and semiautomated impedence type hematology analyzers. It can also be used for manual methods.
Intended use: R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.
Comparison: Both products are used to monitor automated and semi-automated inpedence type hematology instruments. The R&D CBC-3D + CRP added a new parameter.
Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-3D + CRP Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D CBC-3D + CRP 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 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D CBC-3D + CRP Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.
20 、一定
1
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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Mr. Ralph E. Hogancamp Regulatory Affairs R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
JUL 1 0 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K061511
Trade/Device Name: R&D LH-nRBC Hematology Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: June 28, 2006 Received: June 29, 2006
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,
lobatz Beckerh
Robert L. Becker, Jr., MD, P2 Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 0615 | | L K
Device Name: R&D LH-nRBC Hematology Control
Indications for Use:
R&D CBC-3D + CRP Hematology Control is a tri-level control designed to monitor values on automated and semi-automated impedance type hematology analyzers. Refer to assay sheet for specific instrument models.
Over-The-Counter Use Prescription Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO USE ANOTHER PAGE IF NEEDED)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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061511
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