(29 days)
R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to assay sheet for specific instrument models.
This control is a hematology control mixture designed to monitor values obtained from Sysmex hematology instruments.
The provided text describes a 510(k) premarket notification for the "R&D CBC-XE Hematology Control" device. This device is a hematology quality control mixture, not an AI/ML-driven diagnostic device, thus many of the requested categories are not applicable.
Here's an analysis based on the available 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-XE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision | "R&D CBC-XE Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." (Specific values are not provided in this summary but are implied to be acceptable.) |
| Stability (Expiration Dating) | Established at 75 days (closed vial) and 14 days, or 14 samplings (open vial) when stored at 2 - 8° C and handled according to instructions for use. |
| Substantial Equivalence to Predicate Device | "Laboratory testing of 3 validation lots has shown R&D CBC-XE Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "3 validation lots" were tested. The exact number of individual measurements or samples within these lots is not specified.
- Data Provenance: The data appears to be generated internally by R&D Systems, Inc. through "laboratory testing." No information on the country of origin or whether it's retrospective or prospective is provided, but typically such validation is prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This device is a quality control material for hematology instruments, not a diagnostic device that requires expert interpretation for a "ground truth" related to disease states. Its performance is measured against reference values and precision targets, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
- Not Applicable: As stated above, this device does not involve human interpretation or adjudication for its performance assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: This type of study is relevant for diagnostic devices that are interpreted by human readers, often with AI assistance. It is not applicable to an automated hematology control.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes (Implicitly): The "performance, precision, and stability" of the hematology control itself are evaluated directly through laboratory testing using Sysmex hematology instruments. This is inherently a standalone evaluation of the control material's properties. There is no "human-in-the-loop" component in assessing the control material's values.
7. The Type of Ground Truth Used
- Reference Values / Expected Ranges / Precision Targets: For a hematology control, the "ground truth" for each parameter (e.g., cell counts, hemoglobin) would be established by the manufacturer and validated through rigorous testing against reference methods or highly precise internal standards. The summary indicates the device's acceptable performance within "assay ranges" and demonstrates "small standard deviation and % CV's," implying a comparison to known, expected values and precision limits.
8. The Sample Size for the Training Set
- Not Applicable: This device is a physical control material and not an AI/ML algorithm that undergoes "training." Its development and formulation would involve extensive R&D and manufacturing processes, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As explained above, there is no training set for this type of device.
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510(k) Summary R&D Systems, Inc. CBC-XE Hematology Control
| Date of Summary: | July 30, 2004 |
|---|---|
| Company Name: | R&D Systems, Inc.614 McKinley Place N.E.Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp612-656-4413, FAX 612-379-6809 |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D CBC-XE Hematology Control |
| CFR section: | 864.8625 Hematology quality controlmixture. |
| Device Class: | Class II |
Predicate Device: R&D Systems CBC-8K Hematology Control, K913879 manufactured by R&D Systems, Inc. 614 McKinley Place N.F., Minneapolis, MN 55413
Description: This control is a hematology control mixture designed to monitor values obtained from Sysmex hematology instruments.
Intended use: R&D CBC-XF Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to the assay sheet for specific instrument models.
Comparison: Both products are used to monitor Sysmex™ hematology instruments. The R&D CBC-XE added new parameters.
Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-XE Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-XE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D CBC-XE 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 14 days, or 14 samplings (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D CBC-XE 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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Image /page/1/Picture/1 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 lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ralph E. Hogancamp Quality Assurance and Regulatory Affairs Specialist R & D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, Minnesota 55413
K042094 Re:
Trade/Device Name: R & D CBC-XE Hematology Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: July 20, 2004 Received: August 5, 2004
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 rcclassified 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.
SEP - 1 2004
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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has madc 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 cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices 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): K042094
Device Name: R&D CBC-XE Hematology Control
Indications for Use:
्
R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to assay sheet for specific instrument models.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO USE ANOTHER PAGE IF NEEDED)
Josephine Bautista
Division Sign-Off
os of In Vitro Diagnostic Device ﺎ ﺳﺎﺗ Instantion and Seiny
510(k) K042094
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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.