(14 days)
R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.
This control is an assay control mixture for hemocytometer counts. R&D BODY FLUID Control is composed of WBCs and RBCs in a stabilizing medium. R&D BODY FLUID Control simulates cells and body fluids in morphology and count.
The provided text describes the 510(k) summary for the R&D Systems, Inc. BODY FLUID Control device. This device is a quality control mixture for hemocytometer counts, simulating cells and body fluids in morphology and count.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product. | "R&D BODY FLUID Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Demonstrated precision. | "R&D BODY FLUID Control has demonstrated precision as indicated by the small standard deviation and %CV's obtained during laboratory testing." |
| Expiration dating established. | "Expiration dating has been established at 14 weeks in customers hands (closed vial) and 30 days, or 14 entries (open vial) when stored at 2 - 8° C and handled according to instructions for use." |
| Substantial equivalence in performance, precision, and stability to the predicate device (Spinalscopics Control). | "Laboratory testing of 3 validation lots have shown R&D BODY FLUID 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: "Laboratory testing of 3 validation lots" were used for the study. The specific number of individual samples or measurements within each lot is not specified.
- Data Provenance: The study was conducted through "laboratory testing," implying an internal validation study. The country of origin and whether the data was retrospective or prospective are not explicitly stated. However, given it's a 510(k) submission from a US-based company (Minneapolis, MN), it's highly likely to be prospective laboratory testing conducted in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable / not provided for this device. The device is a quality control material, not a diagnostic device that interprets patient data. Its "ground truth" or reference values are inherent to the controlled composition of the product, verified through laboratory testing against established methods, rather than expert interpretation of images or patient cases.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. As mentioned above, the study focuses on the performance characteristics of a quality control product, not on interpreting patient results where adjudication by experts might be needed for ground truth establishment. The performance is assessed against predefined assay ranges and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable, as no such study was conducted. This type of study is relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This device is a quality control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in spirit, a standalone performance was done. The device itself is a control material, and its performance (precision, stability, assay range adherence) was evaluated independently. There isn't an "algorithm" in the typical sense for an AI device, but the performance of the control material (analogous to the "algorithm" in terms of its function) was assessed directly. The intended use is to "monitor total cell counts performed manually using a hemocytometer," so the control itself doesn't involve an automated human-in-the-loop scenario, but rather provides a standard for a manual process.
7. Type of Ground Truth Used
The "ground truth" for this control device is its predefined target values and established assay ranges, determined during its development and manufacturing, and validated through laboratory testing. The study verified that the device remained within these expected ranges and demonstrated precision, and confirmed its "substantial equivalence" to the established performance of the predicate device.
8. Sample Size for the Training Set
This information is not applicable / not provided. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set" in the traditional sense. Its formulation and performance characteristics are established through chemical and biological manufacturing processes and analytical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. As above, there is no "training set" for this type of device. The "ground truth" for the control's performance is established through manufacturing specifications, analytical methods, and comparison to an existing commercially available predicate device.
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K
K020229
FEB 0 6 2002
510(k) Summary R&D Systems, Inc. BODY FLUID Control
| Date of Summary: | January 22, 2002 |
|---|---|
| Company Name: | R&D Systems, Inc. |
| 614 McKinley Place N.E. | |
| Minneapolis, MN 55413 | |
| Contact name: | Ralph E. Hogancamp |
| 612-656-4413, FAX 612-379-6809 | |
| Classification name: | White and Red Blood Cell Control |
R&D BODY FLUID Control 864.8625 Hematology quality control mixture. Class II
Device Class:
Product name:
CFR section:
Predicate Device: Spinalscopics Control, manufactured by Quantimetrix Corporation 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205. 510(k) number: K970862.
Description: This control is an assay control mixture for hemocytometer counts. R&D BODY FLUID Control is composed of WBCs and RBCs in a stabilizing medium. R&D BODY FLUID Control simulates cells and body fluids in morphology and count.
Intended use: R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.
Comparison: Both products are used with manual hemocytometer methods to monitor total cell counts in patient body fluids.
Discussion: Laboratory testing of 3 validation lots have shown R&D BODY FLUID Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D BODY FLUID Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D BODY FLUID Control has demonstrated precision as indicated by the small standard deviation and %CV's obtained during laboratory testing. Expiriation dating has been established at 14 weeks in customers hands (closed vial) and 30 days, or 14 entries (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D BODY FLUID 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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 6 2002
Mr. Ralph E. Hogancamp Quality Specialist R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
Re: K020229
Trade/Device Name: R&D BODY FLUID Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: JPK Dated: January 22, 2002 Received: January 23, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Koao229
Device Name: R&D BODY FLUID Control
Indications for Use:
R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
- (Division Sign-Off)
- Division of Clinical Laboratory Devices
- 510(k) Number KD20229
| Labels | Values |
|---|---|
| Prescription Use | ✓ |
| QR | |
| Over-The-CounterUse |
(Optional Format 1-2-96)
§ 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.