AMMONIA/IRON STANDARD KIT

K972333 · Verichem Laboratories, Inc. · JIX · Jul 23, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972333
• Device Name: AMMONIA/IRON STANDARD KIT
• Applicant: Verichem Laboratories, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Ammonia/Iron Standard 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 Ammonia/Iron Standard Kit serves as a reference material for clinical laboratory test systems. It provides established points of reference used to calibrate or verify the accuracy of assays measuring ammonia and iron concentrations in human specimens. The kit is intended for use by laboratory professionals in clinical settings. By providing known values, the device enables the quantification of analytes in patient samples, supporting clinical decision-making related to metabolic or iron-related disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reference standard kit. Chemical composition designed to provide stable, known concentrations of ammonia and iron for calibration/verification of clinical chemistry analyzers.

Indications for Use

Indicated for use as a reference standard in clinical laboratory test systems to calibrate or verify the measurement of ammonia and iron 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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JUL 2 3 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K972333 Iron Standard Kit Requlatory Class: II Product Code: JIX June 18, 1997 Dated: Received: June 23, 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.

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 requlations 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 requirement, 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 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 Requlations.

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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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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PAGE **_ of _**

510(k) Number (if known): K972333

Device Name: AMMONIA/IRON STANDARD KIT

Indications For Use : .

The Ammonia/Iron Standard 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.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k972333

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)