SEDRite™ Plus 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 and automated ESR methods. Overall performance of the system is monitored including the analyzer, disposable equipment, and technique. SEDRite™ Plus is available in two levels and is run in the same manner as patient specimens.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SEDRite™ Plus Hematology Erythrocyte Sedimentation Rate Control, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the stability characteristics of the control device. Specific quantitative acceptance criteria (e.g., specific ranges for ESR values) are not explicitly stated in this summary. Instead, the general criterion is "recovery of values within the Expected Range."

Acceptance Criteria Category	Specific Criteria (Implicit/General)	Reported Device Performance
Stability (Shelf Life)	Recovery of values within the Expected Range through the life of the product (92 days from shipment).	Values recovered within the Expected Range for 92 days from shipment.
Stability (Open-Vial)	Recovery of values within the Expected Range for 36 days after opening, with proper handling.	Values recovered within the Expected Range for 36 days post-opening, with proper handling.
Substantial Equivalence	Similar intended use, comparable composition (except proprietary change in plasma-like fluid) to predicate device (SEDRite™ Hematology Erythrocyte Sedimentation Rate Control).	Demonstrated substantial equivalence to K972172 (SEDRite™).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size (number of control vials or specific tests performed) used for the stability studies. It broadly refers to "Results of studies."
Data Provenance: The document does not explicitly state the country of origin for the data. Given R&D Systems, Inc. is located in Minneapolis, MN, USA, it's highly probable the studies were conducted in the United States. The studies are prospective in nature, as they involve testing the device over time to establish stability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. For a hematology control, "ground truth" would typically refer to the established expected range of ESR values, which are usually determined through rigorous testing against reference methods or extensive historical data, often involving highly skilled laboratory professionals but not "experts" in the same sense as radiologists interpreting medical images.

4. Adjudication Method for the Test Set

This is not applicable and therefore not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are interpreting results, often for diagnostic accuracy assessments. This device is a control material, so its performance is assessed against established laboratory parameters and expected ranges, not through expert consensus in the same way.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable and therefore not mentioned. MRMC studies are used to assess the impact of a new diagnostic aid (like AI) on human performance. This device is a hematology control for monitoring existing ESR methods, not an AI diagnostic tool.

6. Standalone Performance Study

Yes, a standalone study was performed to demonstrate the device's stability. The "Discussion of performance data" section states: "Results of studies met acceptance criteria for stability was tested by recovery of values within the Expected Range through the life of the product." This refers to the independent performance of the control material itself over time.

7. Type of Ground Truth Used

The "ground truth" for the performance of this control device is the "Expected Range" of Erythrocyte Sedimentation Rate (ESR) values. This range would be established for specific ESR methods and instrumentation, likely through extensive internal validation and external reference methods, ensuring that the control material behaves consistently within these known and acceptable biological and analytical limits.

8. Sample Size for the Training Set

This is not applicable and therefore not mentioned. This device is a control material, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" for this device.

Summary

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K991876

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 stylized, bold font, with the "R" slightly overlapping the "D". Above the "D" is a curved line that connects to the "R". Below the letters "R" and "D" is the word "SYSTEMS" in a smaller, bold font.

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

Date of Summary:	May 28, 1999
Company/Institution name:	R&D Systems, Inc.614 McKinley Place NEMinneapolis, MN 55413-2647
Contact Person:	Sue Gallo
	Phone: (612) 379-2956Fax: (612) 379-6580
Trade name:	SEDRite™ Plus 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:

SEDRite™ Plus Hematology Erythrocyte Sedimentation Rate Control is equivalent to SEDRite™ Hematology Erythrocyte Sedimentation Rate Control currently being sold for in vitro diagnostic use. SEDRite™ is a trademark of R&D Systems, Inc. The FDA document number for the predicate device is K972172.

Device description:

Intended use:

SEDRite™ Plus is a bi-level control for use in monitoring erythrocyte sedimentation rate (ESR) values obtained from manual and automated ESR methods.

Comparison of SEDRite™ Plus to the predicate device:

SEDRite™ Plus has a similar intended use as the predicate device. The composition of SEDRite™ Plus is similar to the predicate device except for a proprietary change in the plasma-like fluid.

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 was tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 92 days from shipment and the open-vial stability is 36 days provided that the product is properly handled according to the package insert instructions.

Conclusions:

SEDRite™ Plus is intended for use as a control to monitor the performance of manual and automated ESR methods. The stability data demonstrate that SEDRite™ Plus is a stable material suitable to use as a control. SEDRite™ Plus is substantially equivalent to SEDRite™ control currently sold for in vitro diagnostic use.

Submitted by:
Sue Sallo

Sue Gallo, BS, MT (ASCP) Quality Assurance Coordinator

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

PHONE: (612) 379-2956 FAX: (612) 379-6580

28 -

WATS: (800) 343-7475 E-MAIL: info@rndsystems.com

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May 28, 1998

PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (As Required by 21 CFR 807.87(j))

Subject: Premarket Notification SEDRite™ Plus Hematology Erythrocyte Sedimentation Rate Control

I certify that, in my capacity as Quality Assurance Coordinator of R&D Systems, Inc., I believe to the best of my knowledge that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Signature: Sue Saller

Sue Gallo

May 28 1999

Dated

Name:

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines.

JUN 17 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sue Gallo Quality Assurance Coordinator R & D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, Minnesota 55413

Re: K991876

Trade Name: SEDRite™ Plus Hematology Erythrocyte Sedimentation Rate Control Regulatory Class: II Product Code: JPK Dated: May 28, 1999 Received: June 2, 1999

Dear Ms. Gallo:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.

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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 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"(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/dsma/dsmamain.html".

Sincerely yours.

Steven Putman

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: May 28, 1999

510(k) Number (if known): 13918 7 6

Device Name: SEDRite™ Plus

Page 1 of 1

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. SEDRite™ Plus is a bi-level control for use in monitoring erythrocyte sedimentation rate (ESR) values obtained from manual and automated ESR methods.

(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 K991876

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

(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.