(325 days)
The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.
For in vitro Diagnostic Use Only
The R&D Body Fluid-I is an assayed, in vitro, whole blood control composed of human and bovine cells in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material. It is sampled in the same manner as a patient specimen.
The provided text describes the R&D Body Fluid-I Hematology Control, an in vitro diagnostic device. This device is a quality control material, not a diagnostic algorithm, and therefore the acceptance criteria and study design elements typically associated with AI/ML-based diagnostic devices (like sample size for test sets, ground truth establishment by experts, MRMC studies, or standalone performance) are not applicable in this context. The study performed is a stability and reproducibility study for a control material, not a clinical study to assess diagnostic accuracy.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Closed vial stability: Remain within range over life of product (75 days claimed) | "The Body Fluid-I Hematology Control passed the acceptance criteria of remaining within range over the life of the product." "It meets the claim of a 75 day closed vial..." |
| Open vial stability: Remain within range over life of product (30 days claimed) | "The Body Fluid-I Hematology Control passed the acceptance criteria of remaining within range over the life of the product." "...and 30 day open vial stability..." |
| Lot-to-lot reproducibility/consistency | "The R&D Systems Body Fluid-I Hematology Control is as safe and effective as the predicate device and is an effective quality control material for evaluating the accuracy and precision of hematology instruments... results confirm lot-to-lot consistency." (Implies meeting an internal standard for consistency) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Three lots were tested to verify the closed vial and open vial stability and lot to lot reproducibility." Each lot contained 3 levels of control material. The specific number of individual samples tested per lot/level or the total number of measurements is not explicitly provided.
- Data Provenance: The studies were internal validation studies conducted by R&D Systems, Inc. The data is prospective, generated specifically for these validation tests. The country of origin for the data generation would be the USA, where R&D Systems, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the device is a quality control material, not a diagnostic algorithm. Ground truth, in the sense of a clinical diagnosis or expert-labeled data, is not established for this type of product. The "ground truth" for a control material is its expected target values and ranges, which are determined by the manufacturer through rigorous testing and assaying on reference instruments.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks. This device is a control material, and its performance is assessed against predefined statistical ranges and stability profiles, not through expert consensus on qualitative interpretation.
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 question is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a quality control material and does not involve AI or human interaction in a diagnostic capacity that would necessitate such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. A standalone performance study evaluates a diagnostic algorithm's accuracy independent of human intervention. The R&D Body Fluid-I Hematology Control is a physical control material, not a software algorithm. Its "performance" is its ability to maintain its assayed values within specified ranges over time and under various conditions.
7. The Type of Ground Truth Used
- The "ground truth" for this device (a hematology control) is its assigned target values and acceptable ranges for red and white blood cell counts. These values are established by the manufacturer through repeated measurements on calibrated reference instruments. The acceptance criteria for stability and reproducibility are defined relative to these established target values and ranges.
8. The Sample Size for the Training Set
- This question is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As it's not an AI/ML algorithm, there is no training set or associated ground truth in that context.
{0}------------------------------------------------
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter Information
| Manufacturer: | |
|---|---|
| Address: |
| Contact: | |
|---|---|
| Phone: | |
| Fax: | |
| Date Prepared: |
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Nancy Ring 612-656-4533 612-379-6580 4/21/2011
Device Information
Trade Name: Common Name: Classification Name: Classification: Product Code: Device Class: Panel:
Body Fluid-I Hematology Control Hematology Control Hematology quality control mixture 21 CFR 864.8625 JPK II Hematology (81)
Predicate Device
Trade Name: 510(k) number: Date:
Streck Cell-Chex™ Auto Hematology Control K053362 January 13th, 2006
Description of Device
The R&D Body Fluid-I is an assayed, in vitro, whole blood control composed of human and bovine cells in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material. It is sampled in the same manner as a patient specimen.
Intended Use:
Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.
{1}------------------------------------------------
R & D Systems, Inc. Body Fluid-I Hematology Control
Comparison to Predicate
Like the previously cleared predicate device, the Body Fluid-I Hematology Control is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.
The difference is the predicate device's biological source is human whereas the Body Fluid-I contains human and bovine biological sources.
Summary of Data
Three lots were tested to verify the closed vial and open vial stability and lot to lot reproducibility. Each lot of control material (each lot containing 3 levels) were stored at 2 - 8° C and tested at real time points at approximately every other week on three different instruments for the purpose of evaluating closed vial stability.
Open vial stability was assessed on three lots of control material (each lot containing 3 levels) and tested near the end of their closed vial shelf life to reflect a worse case scenario. The controls were stored at 2 - 8° C until they were tested. The testing was done according to the instructions for use through at least 30 days and run on one analyzer.
The Body Fluid-I Hematology Control passed the acceptance criteria of remaining within range over the life of the product.
Conclusions Drawn From Tests:
The R&D Systems Body Fluid-I Hematology Control is as safe and effective as the predicate device and is an effective quality control material for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples when used as indicated on the labeling. It meets the claim of a 75 day closed vial, and 30 day open vial stability and results confirm lot-to-lot consistency.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
APR 2 8 2011
R&D Systems, Inc. c/o Ms. Nancy Ring Sr. Quality Assurance/Regulatory Affairs Specialist 614 McKinley Place N.E. Minneapolis, MN, 55413
Re: K101578 Trade/Device Name: Body Fluid-I Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Mixture, Hematology Quality Control Regulatory Class: Class II Product Code: JPK Dated: April 8, 2011 Received: April 12, 2011
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
{3}------------------------------------------------
Page 2 - Ms. Nancy Ring
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m chen
Maria M. Chan, 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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: R&D Body Fluid-I Hematology Control
Indications for Use:
The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.
For in vitro Diagnostic Use Only
Prescription Use _ X (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) Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety
§ 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.