TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL

K972868 · Bionostics, Inc. · JJY · Aug 28, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972868
• Device Name: TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
• Applicant: Bionostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers, b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and; c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro Diagnostic Use only.

Device Story

Bionostics Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Creatinine Control is an in vitro diagnostic quality control material. It consists of three clinically significant levels of analytes used to verify the performance, precision, and accuracy of clinical laboratory analyzers. The device is used by laboratory personnel to monitor instrument performance for blood gas, electrolyte, and metabolite measurements. By confirming that analyzers meet stringent accuracy and precision requirements, the control helps ensure the reliability of patient test results used for clinical decision-making regarding acid-base status and metabolite concentrations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic quality control material provided at three clinically significant levels for monitoring blood gas, electrolyte, and metabolite analyzers. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the precision and accuracy of blood gas, electrolyte, and metabolite analyzers (pH, pCO2, pO2, Na, K, Cl, Li, Ca++, Mg++, glucose, lactate, BUN, creatinine) in clinical settings.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 8 1997

Mr. Bruce R. Williams Executive Vice President Bionostics, Inc. 2 Craig Road Acton, Massachusetts 01720-5405

Re : K972868 Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Trade Name: Creatinine Control Regulatory Class: I Product Code: JJY Dated: July 31, 1997 Received: August 4, 1997

Dear Mr. Williams:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requirement, as set forth in the Quality System Requiation (QS) for Medical Devices: General requlation (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 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 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

Enclosure

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510(k) Number: Not yet assigned

Blood Gas, Electrolyte, Glucose, Lactate, BUN and Device Name: Creatinine Quality Control Product

Date of Submission: 31 July 1997

## INDICATIONS FOR USE:

## A. INTENDED USE

This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers,

- b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and;
- c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites.

The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte.

## This product is for In Vitro Diagnostic Use only.

B. Determination of acid-base status, and the concentrations of oxygon, carbon dioxide, electrolytes and certain critical metabolices in arterial blood is an important adjust to patient monitoring for a variety of clinical conditions.

Since therapeutic regiments are often determined by the results obtained on patient samples, the instruments used to perform these measurements must meet stringent requirements for accuracy and The use of this quality control material is to confirm the precision. performance of instruments which measure critical blood analytes (i.e. electrolytes and critical metabolites) and blood gases and pH.

B. Williams August 8, 1997
Bruce R. Williams

(Division Sign-Off) (Division of Clinical Labor 510(k) Number