(14 days)
Not Found
No
The summary describes a control material for manual cell counting and does not mention any AI or ML components or functionalities.
No
The device is described as an assay control mixture for monitoring cell counts, used to validate the quantitation of red and white cells in patient body fluid samples. Its purpose is for control and validation in laboratory settings, not for treating or diagnosing any medical condition.
No
Explanation: This device is a control used to validate the quantitation of red and white cells in patient body fluid samples, not to diagnose a patient.
No
The device description clearly states it is a "control is an assay control mixture for hemocytometer counts" and is "composed of WBCs and RBCs in a stabilizing medium." This indicates a physical, biological product, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it 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 clearly indicates it is used in vitro (outside the body) to analyze a patient sample (body fluid) for diagnostic purposes (validating cell counts).
- Device Description: The description further supports this by stating it is an "assay control mixture for hemocytometer counts" and "simulates cells and body fluids." This confirms its role in the diagnostic process of analyzing body fluids.
- Performance Studies: The mention of "laboratory testing" and "predicate device" (which is also an IVD control) reinforces its use in a laboratory setting for quality control in diagnostic testing.
Therefore, based on the provided information, the R&D BODY FLUID Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JPK
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)