DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH

K973677 · Sorrento Biochemical, Inc. · JJX · Dec 15, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973677
• Device Name: DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
• Applicant: Sorrento Biochemical, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Device Story

Diascan Aqueous Glucose Controls are ready-to-use liquid solutions containing specific glucose concentrations. Used as quality control samples for blood glucose monitoring kits; they verify system accuracy and performance. Operated by patients at home or healthcare professionals in clinical settings (ER, ICU, CCU, OR). Users apply control solution to the glucose monitoring system in place of a blood sample; the system measures the glucose level and provides a result. Comparison of this result against the expected range provided by the control solution confirms the monitoring system is functioning correctly. This ensures reliable glucose readings for diabetes management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Aqueous glucose solutions; ready-to-use liquid form factor. Intended for use as an external quality control for blood glucose monitoring systems.

Indications for Use

Indicated for use with blood glucose monitoring kits by individuals with diabetes mellitus and healthcare professionals in clinical settings (ER, ICU, CCU, OR, bedside) or home environments to verify glucose monitoring system performance.

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

DEC 1 5 1997

Zak Hassanein President Sorrento Biochemical, Inc. 3443 Tripp Court, Suite A San Diego, California 92121

K973677 Re : Diascan Aqueous Glucose Controls Requlatory Class: I Product Code: JJX September 19, 1997 Dated: Received: September 26, 1997

Dear Mr. Hassanein:

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 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 General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation 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 requlation (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 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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510(k) Number (if known): ___unknown__

## Diescan Aqueous Glucose Control Low Device Name: Diascan Aqueous Glucose Control High

Indication for Use:

Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Divisi Division | |
|------------------|---------|
| 510(k) Nume | K973677 |

| Prescription Use (Per 21 CFR 801-109) | OR Over-The-Counter Use<br> |
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(Optional Format 1-2-96)

: 6 : 8 259 8268

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