R&D HGB/GLC WHOLE BLOOD CONTROL

K993321 · R&D Systems, Inc. · GGM · Nov 12, 1999 · Hematology

Device Facts

• Record ID: K993321
• Device Name: R&D HGB/GLC WHOLE BLOOD CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: GGM · Hematology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.

Device Story

R&D Glucose/Hemoglobin™ Whole Blood Control is an in vitro diagnostic quality control product. It consists of human erythrocytes and glucose in a plasma-like fluid with preservatives. The device is used in clinical laboratory settings to verify the performance of blood analyzers. Laboratory personnel process the control material through the analyzer in the same manner as patient samples. By comparing the analyzer's output for the control against established assay ranges, clinicians assess the accuracy and precision of the instrument. This monitoring ensures the reliability of patient glucose and hemoglobin test results, supporting clinical decision-making and patient safety.

Clinical Evidence

Bench testing only. Performance attributes of stability and precision were evaluated. The device met acceptance criteria for remaining within the assay range over the product life. Expiration dating established at 205 days (closed vial) and 30 days (open vial) when stored at 2-8°C; open vial stability of 7 days at ambient temperature.

Technological Characteristics

Assayed whole blood control composed of human erythrocytes and glucose in a plasma-like fluid with preservatives. Stability: 205 days closed vial, 30 days open vial (2-8°C), 7 days open vial (ambient).

Indications for Use

Indicated for use as an assayed quality control material to monitor the accuracy and precision of clinical analyzers measuring glucose and hemoglobin in whole blood samples.

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

• HO-Chex (K961195)

Submission Summary (Full Text)

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## NOV I 2 1999

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## 510(k) Summary R&D Glucose/Hemoglobin™ Whole Blood Control

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K993321.

Date of Summary: Company Name:

September 30, 1999 R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Kenneth T. Edds, Ph.D. 612-379-2956, FAX [phone]

Contact name:

Classification name: Product name:

ਜਦਾ

R&D Glucose/Hemoglobin™ Whole Blood Control

CFR section: Device Class:

Class II

Device to which substantial equivalence is claimed: HO-Chex, manufactured by Streck Laboratories, Omaha, NE. 510(k) number: K961195

Intended use: R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.

The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.

R&D Glucose/Hemoglobin™ Whole Blood Control has an intended use that is similar to the predicate device. The technology of the two devices is similar.

Nonclinical testing centered on the performance attributes of stability and precision. R&D Glucose/Hemoglobin™Whole Blood Control passed the acceptance criteria of remaining within the assay range over the life of the product. Expiration dating has been established at 205 days closed vial and 30 open vial when stored at 2-8°C and handled according to instructions for use. Vials kept at ambient temperature have an open vial stability of 7 days.

PHONE: [phone] FAX: [phone]

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

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## NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Regulatory Affairs Manager R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413

Re: K993321 Trade Name: R & D Glucose/Hemoglobin™ Whole Blood Control Product Code: GGM Regulatory Class: II JJY I Dated: October 1, 1999 Received: October 4, 1999

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 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 Sutman

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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K993321 510(k) Number:

Device Name:R&D Glu/Hgb Control)

Indications for Use: R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Maher

(Division Sign-Off)
Division of Clinical Laboratory Devices K993321
510(k) Number

Prescription Use √

OR

Over-The-CounterUse

(Optional Format 1-2-96)