MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL

K012243 · Hematronix, Inc. · JJY · Aug 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012243
• Device Name: MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
• Applicant: Hematronix, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine MCC™ ORICHLOR' from HEMATHONIX, three in the clinical laboratory environment. MCC™ multi-consitions intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges used in the methous when furt as a patient sumplo and is ready and physical properties of MCC™ monitoring or quantitutive "constituently" "have themistry analysis.

Device Story

MCC™ URICHECK™ is a synthetic matrix-based, assayed liquid urine control. Used in clinical laboratories to monitor precision and accuracy of urine chemistry analysis instruments. Product is ready-to-use; processed by laboratory personnel as a patient sample. Provides expected ranges for constituents to verify instrument performance and ensure reliable clinical results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Synthetic matrix-based liquid control; ready-to-use; assayed for multiple urine constituents. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use in clinical laboratory environments to monitor the precision and accuracy of urine chemistry analysis instruments. Used as a control sample processed similarly to patient samples.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping stripes, resembling an abstract representation of an eagle or bird in flight.

## AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James SaFranko Director of Operations, Manufacturing Hematronix, Inc. 524 Stone Road, Suite A Benicia, CA 94510

Re: 510(k) Number: K012243 Trade/Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent

Control

Regulation Number: 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: July 16, 2001 Received: July 17, 2001

Dear Mr. SaFranko:

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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{1}------------------------------------------------

Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Autman

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

{2}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control

## Indications For Use:

MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine MCC™ ORICHLOR' from HEMATHONIX, three in the clinical laboratory environment. MCC™ multi-consitions intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges used in the methous when furt as a patient sumplo and is ready and physical properties of MCC™ monitoring or quantitutive "constituently" "have themistry analysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Alexander for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)