SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

K020625 · Helena Laboratories · CIN · May 6, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020625
• Device Name: SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
• Applicant: Helena Laboratories
• Product Code: CIN · Clinical Chemistry
• Decision Date: May 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Indications for Use

The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth and in diseases such as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in blood type O or B after a meal.

Device Story

SPIFE 2000/3000 ALP is an in vitro diagnostic test system for laboratory use; separates serum alkaline phosphatase (ALP) isoenzymes via electrophoresis. System processes serum samples to identify bone, liver, and intestinal isoenzyme fractions. Results assist clinicians in diagnosing and monitoring conditions such as rickets, hepatitis, and cirrhosis. Operated by laboratory technicians; provides qualitative or semi-quantitative separation patterns for clinical interpretation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the electrophoresis system for ALP isoenzyme separation.

Technological Characteristics

Electrophoresis-based test system for serum ALP isoenzyme separation. Operates as an accessory to the SPIFE 2000/3000 instrument platform. Utilizes standard laboratory electrophoresis reagents and gel media. Designed for professional laboratory use.

Indications for Use

Indicated for laboratory use to separate serum ALP isoenzymes in patients with suspected bone, liver, or intestinal disease, including conditions like rickets, hepatitis, and cirrhosis.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, emphasizing its official and governmental nature.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pat Franks Assistant Director/Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752

MAY 0 6 2002

Re: k020625

> Trade/Device Name: SPIFE 2000/3000 ALP Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CIN Dated: March 25, 2002 Received: April 5, 2002

Dear Ms. Franks:

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, 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 (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 (QS) 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 ' 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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):

020625

SPIFE 2000/3000 ALP

Device Name:

Indications for Use:

The test system will be used in laboratories to separate serum ALP The test system will be used in raborations of macrones.

. Elevated bone isoenzyme can be found in conditions of physiologic bone in Elevated bone isoenzyme can be found in concerner and as rickets.

Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver.

Inteatinal isoenzymes can be seen in patients with intestinal disease in
ter and the beach blocktore of or R after a meal . Intestinal Isoenzymed our Bood type O or B after a meal.

Glen Coogin
Division Sign
Division of:
510(k) Number: K020625

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Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)