MATRIX PLUS MULTI-CALIBRATOR KIT

K973345 · Verichem Laboratories, Inc. · JIX · Oct 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973345
• Device Name: MATRIX PLUS MULTI-CALIBRATOR KIT
• Applicant: Verichem Laboratories, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Device Story

The MATRIX PLUS Multi-calibrator Kit functions as an in vitro diagnostic calibrator. It is used in clinical laboratory settings to establish reference points (calibration curves) for analytical test systems. By providing known concentrations of specific analytes, the device allows the laboratory instrument to correlate measured signals with actual substance concentrations in human patient specimens. This calibration process ensures the accuracy and reliability of subsequent patient test results, facilitating clinical decision-making regarding diagnosis and patient management. The device is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator; liquid or lyophilized matrix-based formulation containing known concentrations of analytes; intended for use with clinical chemistry analyzers; non-sterile; no software or electronic components.

Indications for Use

Indicated for use in clinical laboratory test systems to establish reference points for measuring substances in human specimens.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

.. . . ..

Anthony J. DiMonte President Verichem Laboratories, Inc. 90 Narragansett Avenue Providence, Rhode Island 02907

OCT 2 9 1997

Re: K973345 MATRIX PLUS™ Multi-Calibrator Kit Regulatory Class: II Product Code: JIX Dated: September 4, 1997 .... Received: September 5, 1997

Dear Mr. DiMonte:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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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 Requlations, Title 21, Parts 800 to 895. ಗಳ 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 requlatory In addition, FDA may publish further announcements action. 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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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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## EXHIBIT 6: PAGE 1 of l

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: MATRIX PLUS MULTI-CALIBRATOR KIT

Indications For Use:

The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device

Evaluation (ODE)

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K933345

C Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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