DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

K981436 · Casco Standards · JIX · Apr 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981436
• Device Name: DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
• Applicant: Casco Standards
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.

Device Story

The DOCUMENT Ammonia/Ethanol/Lactate Calibrator is an in vitro diagnostic product used to calibrate clinical chemistry analyzers. It provides lot-specific calibration set point values for ammonia, ethanol, and lactate measurements. The calibrator is used in clinical laboratory settings by laboratory professionals to ensure the accuracy of analytical systems. It is not compatible with systems using reflectance spectroscopy. By providing known reference values, the device enables the clinical chemistry system to accurately quantify patient samples, supporting clinical decision-making related to ammonia, ethanol, and lactate levels.

Clinical Evidence

Bench testing only.

Technological Characteristics

In vitro diagnostic calibrator material; liquid or lyophilized form (implied); designed for use with automated, semi-automated, or manual clinical chemistry systems; excludes reflectance spectroscopy-based systems.

Indications for Use

Indicated for in vitro diagnostic quantitative calibration of clinical chemistry systems measuring ammonia, ethanol, and lactate. Not for use on systems employing reflectance spectroscopy.

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

APR 2 4 1998 Ms. Christine V. Beach Manager, Regulatory Affairs CASCO Standards 500 Riverside Industrial Parkway Portland, Maine 04103-1418

Re : K981436 Trade Name: DOCUMENT Ammonia/Ethanol/Lactate Calibrator for use on BMC Hitachi 717 Analyzer Requlatory Class: II Product Code: JIX Dated: April 9, 1998 Received: April 14,1998

Dear Ms. Beach:

laws or regulations.

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 leqally 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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 Reqister. 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

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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 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

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510(k) Number : K981436

DOCUMENI" Ammonia, Ethanol, Lactate Calibrator Device Name:

Indications for Use:

This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT" Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-the -Counter Use

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