SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE

K991876 · R&D Systems, Inc. · JPK · Jun 17, 1999 · Hematology

Device Facts

• Record ID: K991876
• Device Name: SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jun 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

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

Device Story

SEDRite™ Plus is an in vitro diagnostic reagent consisting of mammalian erythrocytes suspended in a plasma-like fluid with preservatives. It functions as a stable control material to monitor the performance of manual and automated ESR testing systems, including the analyzer, disposable equipment, and operator technique. The device is available in two levels and is processed by laboratory personnel in the same manner as patient specimens. By comparing the measured ESR values of the control against established expected ranges, healthcare providers verify the accuracy and reliability of the testing system, ensuring consistent clinical decision-making for patient ESR results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed product performance through a shelf life of 92 days from shipment and an open-vial stability of 36 days, with recovery of values within established expected ranges.

Technological Characteristics

In vitro diagnostic reagent; mammalian erythrocytes in plasma-like fluid with preservatives; bi-level formulation; stable liquid control; manual and automated ESR method compatibility.

Indications for Use

Indicated for use as a bi-level quality control material to monitor the performance of manual and automated erythrocyte sedimentation rate (ESR) diagnostic test methods in a laboratory setting.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• SEDRite™ Hematology Erythrocyte Sedimentation Rate Control (K972172)

Submission Summary (Full Text)

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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.<br>614 McKinley Place NE<br>Minneapolis, MN 55413-2647 |
| Contact Person: | Sue Gallo |
| | Phone: [phone]<br>Fax: [phone] |
| Trade name: | SEDRite™ Plus Hematology Erythrocyte<br>Sedimentation Rate Control |
| Classification/Common Name: | Hematology Quality Control Mixture<br>(per 21 CFR 864.8625) |
| Classification Code/Device Class: | 81JPK Hematology Control Mixtures<br>for 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:

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.

#### 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: [phone] FAX: [phone]

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WATS: [phone] E-MAIL: [e-mail]

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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 [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 regulation (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/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.

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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)