(45 days)
Not Found
No
The description focuses on a manual control for a manual procedure and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is an in vitro diagnostic reagent used to monitor the performance of manual Erythrocyte Sedimentation Rate (ESR) procedures, not to treat a condition or disease.
No
Explanation: ESR Control-M™ is a hematology control, not a diagnostic device. It is used to "document and monitor values obtained from manual ESR procedures" and to "monitor the performance of manual ESR procedures" and the "overall performance of the entire system," not to diagnose a disease or condition in a patient.
No
The device is described as an in vitro diagnostic reagent composed of physical materials (mammalian erythrocytes, plasma-like fluid, preservatives) and is used to monitor manual ESR procedures, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is "designed to document and monitor values obtained from manual ESR procedures." This indicates it's used in a laboratory setting to assess the performance of a diagnostic test (ESR).
- Device Description: The "Device Description" section clearly states it is an "in vitro diagnostic reagent." It also describes its composition and purpose in monitoring the performance of manual ESR procedures, which are diagnostic tests performed outside of the body.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K940430) is a strong indicator that this device has gone through a regulatory process for IVDs, likely a 510(k) submission to the FDA. Predicate devices are legally marketed devices that are substantially equivalent to the new device being submitted for clearance, and this process is specific to IVDs and other medical devices.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ESR Control-M™ is a bi-level hematology control designed to document and monitor values obtained from manual ESR procedures.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
ESR Control-M™ is an in vitro diagnostic reagent composed of mammalian erythrocytes suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of manual ESR procedures. Overall performance of the entire system is monitored including disposable ESR tubes, technique, and important environmental factors. ESR Control-M™ is available in two levels and is run in the same manner as patient specimens.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 45 days from shipment and the openvial stability is 14 days provided that the product is properly handled according to the package insert instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KA72172
JUL 2 4 1997
Image /page/0/Picture/2 description: The image shows a logo for "R&D Systems". The logo features the letters "R" and "D" in a bold, sans-serif font, with a stylized image of a microscope or scientific instrument placed between the letters. Below the letters, the word "SYSTEMS" is written in a smaller, bold, sans-serif font.
510(k) SUMMARY ESR Control-M™ HEMATOLOGY CONTROL
| Date of Summary: | June 5, 1997 |
|---|---|
| Company/Institution name: | R&D Systems, Inc. |
| 614 McKinley Place NE | |
| Minneapolis, MN 55413-2647 | |
| Contact Person: | Sue Gallo Phone: (612) 379-2956 |
| Fax: (612) 379-6580 | |
| Trade name: | ESR Control-M™ Hematology Erythrocyte |
| Sedimentation Rate Control | |
| Classification/Common Name: | Hematology Quality Control Mixture |
| (per 21 CFR 864.8625) | |
| Classification Code/Device Class: | 81JPK Hematology Control Mixtures |
| for Quality Control/Class II |
Substantial equivalence:
ESR Control-M™ Hematology Control is substantially equivalent to MSI HEMA-Trol™, a hematology control currently being sold for in vitro diagnostic use. MSI HEMA-Trol™ is a trademark of Medical Specialties International. Inc. 3610 Kennedy Road. South Plainfield. NJ 07080. The FDA document number for the predicate device, MSI HEMA-Trol™, is K940430.
Device description:
ESR Control-M™ is an in vitro diagnostic reagent composed of mammalian erythrocytes suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of manual ESR procedures. Overall performance of the entire system is monitored including disposable ESR tubes, technique, and important environmental factors. ESR Control-M™ is available in two levels and is run in the same manner as patient specimens.
Intended use:
ESR Control-M™ is a bi-level hematology control designed to document and monitor values obtained from manual ESR procedures.
Comparison of ESR Control-M™ to the predicate device:
ESR Control-M™ has the same intended use as the predicate device. The composition of ESR Control-M™ is similar to the predicate device except mammalian engthrocytes are used instead of human erythrocytes thus eliminating the risks of exposure to human blood borne viruses.
Discussion of performance data:
The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 45 days from shipment and the openvial stability is 14 days provided that the product is properly handled according to the package insert instructions.
Conclusions:
ESR Control-M™ is intended for use as a control to monitor the performance of manual ESR procedures. The stability data demonstrate that ESR Control-M™ is a stable material suitable to use as a control. ESR Control-M™ is substantially equivalent to MSI HEMA-Trol™ currently sold for in vitro diagnostic use.
Submitted by:
Sue Gallo, B.S., M.T. (ASCP) Quality Assurance Coordinator
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R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
Phone: (612) 379-2956 FAX: (612) 379-6580
WATS: (800) 428-4246 WATS: (800) 523-3395
Customer Service Technical Service & QC Program
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth Edds, Ph.D. Manager, Regulatory Affairs JUL_2 4 1997 R & D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, Minnesota 55413 K972172 Re :
ESR Control-M™ Hematology Erythrocyte Sedimentation Rate Control Regulatory Class: II Product Code: JPK Dated: June 5, 1997 Received: June 9, 1997
Dear Dr. Edds:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 requlation (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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
Date: June 5, 1997
Page 1 of 1
510(k) Number (if known):
Device Name: ESR Control-M™
Submitted by: R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
Indications for Use:
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. ESR Control-M™ is a bi-level hematology control designed to document and monitor values obtained from manual ESR procedures.
(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 | K972178 |
| Prescription Use
| (Per 21 CFR 801.109) | / | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | ---------------------- | -- |
(Optional Format 1-2-96)
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