R&D GLU-LINE HEMATOLOGY CONTROL

K034048 · R&D Systems, Inc. · JJX · Mar 10, 2004 · Clinical Chemistry

Device Facts

• Record ID: K034048
• Device Name: R&D GLU-LINE HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The R & D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose determinations

Device Story

Multilevel control material used to monitor glucose analyzers; provides means of measuring linearity for glucose parameter. Used in laboratory settings by clinical personnel to verify instrument performance. Product remains within assay range over 105-day shelf life when stored at 2-8°C. Helps ensure accuracy and reliability of glucose measurements on hematology instruments.

Clinical Evidence

No clinical data. Bench testing only; mean values derived from replicate analysis using manufacturer-supported reagents.

Technological Characteristics

Multilevel hematology quality control mixture. Liquid-based control for glucose parameter linearity. Storage requirement: 2-8°C. Shelf life: 105 days (closed vial).

Indications for Use

Indicated for use as a multilevel control to measure the linearity of glucose analyzers for glucose parameter determinations in a laboratory setting.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• R&D Systems Glucose Hemoglobin Hematology Control (K993321)

Submission Summary (Full Text)

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K034048

## 510(k) Summary R&D Systems, Inc. GLU-LINE Hematology Control

| Date of Summary: | December 16, 2003 |
|----------------------|-----------------------------------------------------------------------|
| Company Name: | R&D Systems, Inc.<br>614 McKinley Place N.E.<br>Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp<br>612-656-4413, FAX [phone] |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D GLU-LINE Hematology Control |
| CFR section: | 864.8625 Hematology quality control<br>mixture. |
| Device Class: | Class II |

Predicate Device: R&D Systems Glucose Hemoglobin Hematology Control, K993321 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413

Description: This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.

Intended use: R&D GLU-LINE Hematology Control is designed as a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.

Comparison: Both products are used to monitor glucose on hematology instruments.

Discussion: Laboratory testing of 3 validation lots has shown R&D GLU-LINE Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D GLU-LINE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D GLU-DINE Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. Expiriation dating has been established at 105 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D GLU-LINE Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 0 2004

Mr. Ralph E. Hogancamp Quality Assurance Specialist R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

> k034048 Trade/Device Name: R & D GLU-LINE Hematology Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material(assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: December 24, 2003 Received: December 30, 2003

Dear Mr. Hogancamp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Device Name: R&D GLU-LINE Hematology Control

Indications for Use:

R&D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

Over-The-CounterUse

(Optional Format 1-2-96)

Carl Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k).

(