(39 days)
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.
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.
Here's an analysis of the provided text regarding the R&D CBC-3D + CRP Hematology Control, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the product life | "R&D CBC-3D + CRP Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision (demonstrated by small standard deviation and % CVs) | "R&D CBC-3D + CRP Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." |
| Stability (closed vial) | "Expiriation dating has been established at 105 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use." (Implies meeting stability criteria for this duration) |
| Stability (open vial) | "Expiriation dating has been established at... 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use." (Implies meeting stability criteria for this duration) |
| Substantial equivalence in performance | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in performance... to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
| Substantial equivalence in precision | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in... precision... to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
| Substantial equivalence in stability | "Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in... stability to the predicate device [R&D Systems CBC-3D Hematology Control, K843962]." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "3 validation lots" were tested. No further breakdown of the number of individual tests or samples within these lots is provided.
- Data Provenance: The study was conducted through "Laboratory testing," implying an internal validation study by R&D Systems, Inc. The country of origin of the data is not explicitly stated but is implicitly the USA, where the company is located. The study is prospective in nature, as it involves testing new validation lots before market release to establish performance and stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a hematology quality control mixture, the "ground truth" would likely be established by the manufacturing specifications and reference methods, not by human experts in the way image analysis or clinical diagnosis might require.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a quality control product, adjudication by multiple experts is unlikely to be a relevant method. The "ground truth" (or target range) for such a device is typically defined by the assay sheet and manufacturing specifications rather than expert consensus on individual results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for a hematology quality control mixture, which is not an AI-powered diagnostic device but rather a calibration and quality assurance tool for laboratory instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study, as typically understood for an AI algorithm, was not done. This device is a consumable for instruments, not an algorithm itself. The performance assessment was of the control mixture's ability to maintain its specified values over time and across different lots, in comparison to a predicate device.
7. The Type of Ground Truth Used
The ground truth used for this device would be the established assay ranges and target values as per the manufacturer's specifications for the control material, and the expected performance characteristics based on the predicate device. This is implicitly derived from established reference methods for hematology parameters. It's not "expert consensus," "pathology," or "outcomes data" in the typical sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a physical diagnostic control, not an AI model requiring a training set. The "training" for such a product involves its formulation and manufacturing process development, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above. The "ground truth" in the context of developing such a control would be the desired target values for the hematology parameters and the stability characteristics determined through extensive R&D and calibration against reference materials and methods.
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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. Hogancamp612-656-4413, 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 controlmixture. |
| 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
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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 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
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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
Page 1 of 1
061511
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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.