LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

K971754 · Pointe Scientific, Inc., · CFR · Jul 22, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971754
• Device Name: LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.

Device Story

Liquid Glucose (Hexokinase) Reagent Set is an in vitro diagnostic reagent kit used in clinical laboratory settings. Qualified laboratory technologists use the reagents to perform quantitative glucose measurements on serum or plasma samples. The device utilizes the hexokinase enzymatic method to determine glucose concentration. Results are used by clinicians to aid in the diagnosis and management of diabetes mellitus. The device is intended for professional use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent set; hexokinase enzymatic assay principle; liquid format; intended for use with clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of glucose in serum or plasma for the diagnosis and treatment of diabetes mellitus in patients requiring clinical laboratory testing.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, 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

JUL 22 1997

William F. Walters, Jr. Vice President, Technical Operations Pointe Scientific, Inc 1025 John A. Papalas Drive Lincoln Park, Michigan 48146

K971754 Re : Liquid Glucose (Hexokinase) Reagent Set Requlatory Class: II Product Code: CFR Dated: May 6, 1997 Received: May 12, 1997

Dear Mr. Walters:

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 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 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 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 w 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 diaqnostic 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 Litman

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 at this time

## Device Name:_Liquid Glucose (Hexokinase) Reagent Set

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.

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| 0(k) Number | K971754 |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
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| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use___

(Optional Format 1-2-96)