ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION

• K Number: K972172
• Device Name: ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
• Manufacturer: R & D SYSTEMS, INC.
• Date Cleared: 1997-07-24 ( 45 days)
• Product Code: JPK
• Regulation Number: 864.8625
• Type: Traditional
• Panel: Hematology
• Reference & Predicate Devices: K940430
• Predicate For: K991876

Intended Use

ESR Control-M™ is a bi-level hematology control designed to document and monitor values obtained from manual ESR procedures.

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.

AI/ML Overview

The provided text describes the ESR Control-M™ Hematology Control, a device designed to monitor the performance of manual Erythrocyte Sedimentation Rate (ESR) procedures.

Here's an analysis based on the given information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Stability by recovery of values within the Expected Range through the life of the product	Met acceptance criteria. The shelf life is established as 45 days from shipment. Open-vial stability is 14 days, provided proper handling. This implies that the device's values remained within the expected range for these specified periods.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size used for the stability testing.
   • It does not specify the data provenance (country of origin, retrospective/prospective). The study was likely conducted by R&D Systems, Inc. in Minneapolis, MN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • The document does not provide information on the number of experts or their qualifications for establishing ground truth. The 'ground truth' here refers to the "Expected Range" for ESR values, which would typically be established based on standardized laboratory methods and potentially expert consensus on what constitutes an acceptable range for a control.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not describe any adjudication method.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hematology control material, not an AI-powered diagnostic device, so such a study would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This device is a physical control reagent, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth referred to as "Expected Range" for the ESR values of the control. This "Expected Range" would likely be established through internal validation studies, reference to predicate devices, and adherence to established clinical laboratory standards for hematology controls. It's an internal standard for the expected performance of a well-functioning manual ESR procedure when using the control.

8. The sample size for the training set:

   • The concept of a "training set" is not applicable to this device, as it is a physical control reagent and not a machine learning model.

9. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

Study Proving Device Meets Acceptance Criteria:

The device's performance is proven through stability studies. The document states:
"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 open-vial stability is 14 days provided that the product is properly handled according to the package insert instructions."

This indicates that R&D Systems, Inc. conducted internal testing which demonstrated that the ESR Control-M™ maintained its expected ESR values for the claimed shelf life and open-vial stability periods. The study would have involved storing the control material under specified conditions and then measuring its ESR values at various time points to ensure they remained within the pre-defined "Expected Range." This type of study is standard for in vitro diagnostic reagents to establish their stability and shelf life.

Summary

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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 NEMinneapolis, MN 55413-2647
Contact Person:	Sue Gallo Phone: [phone]Fax: [phone]
Trade name:	ESR Control-M™ Hematology ErythrocyteSedimentation Rate Control
Classification/Common Name:	Hematology Quality Control Mixture(per 21 CFR 864.8625)
Classification Code/Device Class:	81JPK Hematology Control Mixturesfor 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: [phone] FAX: [phone]

WATS: [phone] WATS: [phone]

Customer Service Technical Service & QC Program

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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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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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
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(Optional Format 1-2-96)

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Regulation Number and Section

§ 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.