ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01

K990162 · Bio-Rad · JJX · Jan 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990162
• Device Name: ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Abbott Liquid Ammonia Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

Device Story

Abbott Liquid Ammonia Control is a quality control serum used in clinical laboratories to monitor the precision of testing procedures for specific analytes. The device serves as a reference material to verify the accuracy and reliability of laboratory assays. It is intended for professional use by laboratory personnel to ensure consistent performance of diagnostic equipment and reagents. By comparing observed results against established values, clinicians can validate the performance of their testing systems, thereby supporting accurate patient diagnosis and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid quality control serum; intended for in vitro diagnostic use to monitor laboratory testing precision.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specified analytes in a clinical 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.

Submission Summary (Full Text)

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Public Health Service

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JAN 28 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re: K990162 Trade Name: Abbott Liquid Ammonia Control Regulatory Class: I Product Code: JJX Dated: January 13, 1999 Received: January 19, 1999

Dear Ms. Platt:

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

Sincerely vours,

Steven Putman

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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K990162 510(k) Number: ______________________________________________________________________________________________________________________________________________________________ Device Name: Abbott Liquid Ammonia Control

Indications for Use:

Abbott Liquid Ammonia Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990162

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use ✓

OR Over-The Counter Use _