It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. ESR Control-HC™ is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated erythrocyte sedimentation rate analyzers.

Device Description

ESR Control-HC™ 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 HiChem Mini-VES and VES-Matic automated ESR analyzers. Overall performance of the entire system is monitored including the analyzer, disposable equipment, and technique. ESR Control-HC™ is available in two levels and is run in the same manner as patient specimens.

AI/ML Overview

The provided document K972170 is a 510(k) Pre-Market Notification for the ESR Control-HC™ Hematology Control. This document is a submission for a quality control device, not a diagnostic device that directly "performs" with clinical data or generates diagnostic outputs that would have detailed performance metrics like sensitivity, specificity, or AUC based on patient data.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

The "performance data" discussed in this 510(k) is related to the stability of the control material itself, ensuring it remains consistent and reliable for its intended purpose of monitoring automated ESR analyzers. The acceptance criteria relate to the control values falling within an "Expected Range" over time.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Stability tested by recovery of values within the Expected Range through the life of the product.	"Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product."
Shelf life	56 days from shipment
Open-vial stability	14 days (provided proper handling)

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

Sample Size for Test Set: Not explicitly stated in the provided document. The studies were focused on the stability of the control material, not on a diagnostic test applied to patient samples.
Data Provenance: Not specified, but likely internal laboratory testing performed by R&D Systems, Inc. (USA). The nature of the device (a quality control material) suggests prospective in-house testing rather than retrospective data from a specific country's patient population.

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)

Not Applicable. The "ground truth" for a hematology control is its expected value range and stability over time, determined by internal validation and adherence to established quality control principles, not by expert interpretation of images or patient data.

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

Not Applicable. Adjudication methods are typically used for clinical endpoints or diagnostic interpretations, which are not relevant to the performance assessment of a quality control material.

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

Not Applicable. This device is a hematology control, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory submission.

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

Not Applicable. This device is a physical reagent (hematology control), not an algorithm or AI system.

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

The "ground truth" indirectly refers to the expected range of values for the erythrocyte sedimentation rate (ESR) that the control material is designed to demonstrate when run on automated ESR analyzers. This "Expected Range" would be established internally by the manufacturer through rigorous testing and validation, typically against reference methods or established quality control standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not Applicable. This device is a physical reagent, not an algorithmic model that requires training data.

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

Not Applicable. (As above, no training set for a physical control material).

Summary

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K972170

1111 24 1997

Image /page/0/Picture/1 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 an ampersand symbol (&) placed between them. Below the letters, the word "SYSTEMS" is written in a smaller, distressed font. The overall design is simple and professional, suggesting a company involved in research and development.

510(k) SUMMARY ESR Control-HC™ HEMATOLOGY CONTROL

Date of Summary:	June 6, 1997
Company/Institution name:	R&D Systems, Inc.614 McKinley Place NEMinneapolis, MN 55413-2647
Contact Person:	Sue Gallo
	Phone: (612) 379-2956
	Fax: (612) 379-6580
Trade name:	ESR Control-HC™ 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-HC™ 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-HC™ is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated ESR analyzers.

Comparison of ESR Control-HC™ to the predicate device:

ESR Control-HC™ has the same intended use as the predicate device. The composition of ESR Control-HC™ is similar to the predicate device except mammalian erythrocytes are used instead of human ervthrocytes 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 56 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-HC™ is intended for use as a control to monitor the performance of HiChem Mini-VES and VES-Matic automated ESR analyzers. The stability data demonstrate that ESR Control-HC™ is a stable material suitable to use as a control. ESR Control-HC™ is substantially equivalent to MSI HEMA-Trol™ currently sold for in vitro diagnostic use.

Submitted by:
Sue Sallo

Sue Gallo, B.S., M.T. (ASCP) Quality Assurance Coordinator

16 -

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

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Received: June 9, 1997

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles, which are meant to represent the department's focus on people and their well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth Edds, Ph.D. JUI 24 1997 · Manager, Regulatory Affairs R & D Systems, Inc. ... . . ...... 614 McKinley Place, N.E. Minneapolis, Minnesota 55413 Re: K972170 ESR Control-HC™ Hematology Erythrocyte Sedimentation Rate Control Requlatory Class: II Product Code: JPK Dated: June 6, 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 Gutman

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 6, 1997

Page 1 of 1

510(k) Number (if known):

Device Name: ESR Control-HC ™

Submitted by: R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	acting BC
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K922170

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

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.