RETIC-QUINOX

K993496 · Hematronix, Inc. · JPK · Nov 30, 1999 · Hematology

Device Facts

• Record ID: K993496
• Device Name: RETIC-QUINOX
• Applicant: Hematronix, Inc.
• Product Code: JPK · Hematology
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.

Device Story

Retic-Quinox is an in vitro diagnostic control material used in clinical laboratory settings to verify the performance of Coulter hematology analyzers. The device consists of stabilized human red cells combined with a nucleated, reticulocyte-like component suspended in a buffered, bacteriostatic, and fungistatic fluid. It is provided in three distinct levels to assess instrument accuracy and precision across the measurement range. Laboratory personnel use the control to monitor the system's reticulocyte counting function. By comparing the analyzer's output against the known values of the control, clinicians ensure the reliability of patient test results, thereby supporting accurate diagnosis and monitoring of hematological conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic control; stabilized human red cells and nucleated reticulocyte-like component; buffered, bacteriostatic, and fungistatic fluid; three-level concentration format; designed for Coulter instruments using VCS technology.

Indications for Use

Indicated for use as a whole blood reference control material to monitor the accuracy and precision of Coulter instruments with reticulocyte measuring capabilities using VCS technology.

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

• Retic-C manufactured by Coulter Diagnostics (K930119)

Submission Summary (Full Text)

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## 510(k) SUMMARY

"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: K9934902 ."

For any questions contact:

James D. Lapicola 524 Stone Road Benicia, CA 94510 [phone] ext. 208 FAX: [phone]

Date Prepared: October 11, 1999

Gentlemen:

Following is a summary of the basis for a substantially equivalent determination:

Trade or proprietary name, Common or usual name Classification name Product Code 81JPK CFR Section 21 CFR 864.8625 Device Class II Hematology Classification Panel

Retic-Quinox Reticulocyte Control Mixture Mixture, Hematology Quality Control

## Predicate Device Information:

Trade or proprietary name, Common or usual name Classification name 510(K) Number: K930119 Approval Date: 4/5/93 21CFR864.8625, Hematology Quality Control Mixture Product Code JPK Hematology Panel

Retic-C manufactured by Coulter Diagnostics Reticulocyte Control Mixture Mixture, Hematology Quality Control

## Device Description:

Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.

## Technological Characteristic Comparison

Both Coulter's Retic-C and Hematronix' Retic-Quinox are in vitro diagnostic controls composed of stabilized human red cells in combination with a reticulocyte-like component suspended in a buffered, bacteriostatic and fungistatic fluid. In both products, the reticulocyte-like component is a cell of similar size to a human red cell and which contains a nucleus. In both products, three levels are provided in order to better monitor the Coulter instrument's accuracy and precision.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with three lines representing its head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 30 1999

Mr. James D. Lapicola Executive Vice President Hematronix, Inc. 524 Stone Road Suite A Benicia, California 94510

K993496 Re: Trade Name: Retic-Quinox Regulatory Class: II Product Code: JPK Dated: October 11, 1999 Received: October 15, 1999

Dear Mr. Lapicola:

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 (OS) 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_1934 96

Retic-Quinox Device Name: __

Indications For Use:

Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita E. Madan

_
Prescription Use
(Per 21 CFR 801.109)

. 1994

OR

Over-The-Counter Use_