← Product Code [JHO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO) · K013466 # SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466) _Helena Laboratories · JHO · Dec 21, 2001 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO/K013466 ## Device Facts - **Applicant:** Helena Laboratories - **Product Code:** [JHO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO.md) - **Decision Date:** Dec 21, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1475 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol are associated with atherosclerosis which leads to cardiovascular disease and strokes. ## Device Story The SPIFE 2000/3000 Lipoprotein System is an automated electrophoresis system used in clinical laboratories. It processes serum samples to separate and quantify lipoproteins. The system utilizes agarose gel electrophoresis to separate lipoprotein fractions; these fractions are then stained and scanned to produce densitometric profiles. The output provides quantitative data on lipoprotein distribution, which clinicians use to assess lipid profiles and evaluate risks for atherosclerosis, cardiovascular disease, and stroke. The device is operated by trained laboratory personnel in a clinical setting to assist in the diagnosis and management of lipid-related disorders. ## Clinical Evidence No clinical data provided; substantial equivalence is based on the device's classification and intended use as a standard lipoprotein test system. ## Technological Characteristics Automated electrophoresis system; utilizes agarose gel electrophoresis for separation; includes densitometric scanning for quantification; intended for clinical laboratory use; Class I, reserved; Product Code JHO. ## Regulatory Identification A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 2 1 2001 Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. P.O. Box 752 1530 Lindbergh Drive Beaumont, TX 77704-0752 Re: k013466 > Trade/Device Name: Spife 2000/3000 Lipoprotein System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: October 17, 2001 Received: October 18, 2001 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. {1}------------------------------------------------ Page 2 - 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 i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ Page 510(k) Number (if known): SPIFE 2000/3000 Lipoprotein System Device Name: Indications for Use: The SPIFE 2000/3000 Lipoprotein System is useful in the prevention ine of Ira 2000/3000 Expopulary heart disease. Increased dietary fats and ana decocio. Or oto atherosclerosis which leads to cardiovascular disease and strokes. Heim Coogan (Division Sign-Off) Division of Clinical Laboratory Devices (Division 510(k) No. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) OR Concurrence of CDRH, Office of Device Evaluation (ODE) ﺳﺎ Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO/K013466](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHO/K013466) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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