MICROALBUMIN REAGENT SET AND CALIBRATORS

K023860 · Pointe Scientific, Inc., · DDZ · Apr 28, 2003 · Immunology

Device Facts

• Record ID: K023860
• Device Name: MICROALBUMIN REAGENT SET AND CALIBRATORS
• Applicant: Pointe Scientific, Inc.,
• Product Code: DDZ · Immunology
• Decision Date: Apr 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• 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 low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.

Device Story

In vitro diagnostic reagent for quantitative determination of low-level albumin in human urine; used in clinical laboratory settings by qualified technologists. Principle of operation involves immunological test system for albumin detection. Output provides quantitative albumin concentration levels to assist clinicians in assessing early glomerular disease and predicting diabetic nephropathy risk. Device intended for prescription use.

Clinical Evidence

No clinical data provided; device relies on established immunological test system principles for quantitative albumin measurement.

Technological Characteristics

Immunological test system for albumin; in vitro diagnostic reagent; quantitative measurement; laboratory-based analysis.

Indications for Use

Indicated for quantitative determination of low-level albumin in human urine in a diagnostic laboratory setting. Used as an indicator of early glomerular disease and to predict development of diabetic nephropathy and mortality risk.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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 § 866.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 8 2003

Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146

Re: k023860

> Trade/Device Name: Microalbumin Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DDZ; JIT Dated: February 10, 2003 Received: February 12, 2003

Dear Mr. Jamison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):

K 023860

Device Name: Microalbumin

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.

Han Cooper

(Division Sior-Off)

Division o Clinical Laboratory Devices

510(k) Number K023860

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Counter Use (Per 21 CFR 801.109)

OR

Over the

(Optional Format 1-2-96)