ALBUMIN REAGENT

K021636 · Intersect Systems, Inc. · CJW · Jul 17, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021636
• Device Name: ALBUMIN REAGENT
• Applicant: Intersect Systems, Inc.
• Product Code: CJW · Clinical Chemistry
• Decision Date: Jul 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Story

Albumin Reagent is an in vitro diagnostic reagent used to measure albumin concentration in serum or plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. It provides quantitative results that assist healthcare providers in diagnosing and monitoring conditions affecting the liver or kidneys. The reagent facilitates clinical decision-making by providing objective data on patient albumin levels, which can indicate nutritional status, liver function, or renal health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for quantitative albumin measurement. Operates via standard clinical chemistry methodology for albumin detection in serum or plasma samples.

Indications for Use

Indicated for the quantitative measurement of albumin concentration in human serum or plasma to aid in the diagnosis and treatment of liver or kidney diseases.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 1 7 2002

Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. P.O. Box 2219 Longview, WA 98632

Re: k021636 Trade/Device Name: Albumin Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CJW Dated: May 10, 2002 Received: May 17, 2002

Dear Dr. Legaz:

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. Ilisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.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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## Indication for Use

Trade Name of the Device:

Albumin Reagent

**510(k) Number:** K021636

Classification Name; Number: Albumin Test System; 21 CFR §862.1035

## Indications for Use

An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Lan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K021636