(97 days)
HC WBC Control is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. Refer to the assay table for specific instrument models.
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The HC WBC Hematology Control is designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood.
The HC WBC Hematology Control is an in vitro diagnostic control composed of human erythrocytes and bovine leukocytes in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. It is sampled in the same manner as a patient specimen.
This document describes the HC WBC Hematology Control, an in vitro diagnostic control used to monitor white blood cell counts.
Here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the stated life of the product (stability) | Passed the acceptance criteria of remaining within the assay range over the stated life of the product. |
| Precision (standard deviation and % CV) | Demonstrated precision as indicated by the standard deviation and % CV's obtained during laboratory testing. |
| Substantial equivalence in performance to the predicate device | Achieved substantial equivalence to the legally marketed predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The study utilized "3 validation lots" of the HC WBC Hematology Control. The specific number of individual test samples within these lots is not provided.
- Data Provenance: The testing was conducted as "Laboratory testing," indicating it was likely performed in a controlled laboratory environment by the manufacturer (R&D Systems, Inc.). No information is provided regarding the country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a hematology control, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for a control material is typically its known, established target values and acceptable ranges.
4. Adjudication method for the test set:
This information is not applicable as the device is a hematology control. Adjudication methods like 2+1 or 3+1 are used for human expert review of diagnostic cases, which is not relevant here.
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:
This information is not applicable as the device is a hematology control and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a hematology control used for quality control of analytical instruments, not a standalone diagnostic algorithm.
7. The type of ground truth used:
The ground truth for this device would be the known, established target values and acceptable ranges for white blood cell counts that the control product is designed to represent and monitor. These values are determined during the manufacturing and characterization of the control material according to established laboratory and quality control standards.
8. The sample size for the training set:
This information is not applicable. Hematology controls are manufactured to specific specifications and then validated. They are not "trained" in the machine learning sense. The "3 validation lots" mentioned are for performance testing, not training.
9. How the ground truth for the training set was established:
This information is not applicable. As mentioned above, hematology controls do not have a "training set" in the context of machine learning. The "ground truth" for the control material itself (i.e., its expected WBC count and range) is established during its manufacturing process, likely through highly precise reference methods and extensive testing, to ensure its accuracy as a control.
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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
NOV 2 0 2007
Date Prepared: 8/14/07
Device Information
Proprietary Name: HC WBC 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-3K Hematology Control, (K904464) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.
Description of Device
The HC WBC Hematology Control is an in vitro diagnostic control composed of human erythrocytes and bovine leukocytes in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. It is sampled in the same manner as a patient specimen.
Intended Use:
HC WBC Control is an assayed whole blood control designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood. Refer to the assay table 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 values from analyzers that measure white blood cell counts in whole blood. Both are used to perform quality controls assays. The HC WBC Hematology Control has monitors a single parameter.
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Summary of Performance Data
Laboratory testing of 3 validation lots has shown the HC WBC Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The HC WBC Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product. The HC WBC Hematology Control has demonstrated precision as indicated by the standard deviation and % CV's obtained during laboratory testing.
Substantial Equivalence Conclusion
The data demonstrates that the HC WBC 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 features a stylized eagle with three lines forming its body and wings. 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
NOV 2 0 2007
R & D Systems, Inc. C/O Nancy C. Ring 614 McKinley Place, NE Minneapolis, Minnesota 55413
Re: K072268
Trade/Device Name: HC WBC Hematology Control, Model: WBC00S Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: August 14, 2007 Received: August 15, 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 Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. 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,
Ausphine Surtida
Robert er. Jr. 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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August 14, 2007
Indications for Use
510(k) Number (if known): _ _ K072269
Device Name: _HC WBC Hematology Control
Indications for Use:
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The HC WBC Hematology Control is designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood.
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)
Division Sien/Off
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of In Vitro Diagnostic Device lation and Sat
§10(k) K072248
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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.