← Product Code [NUM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM) · K050662 # QUANTA LITE SP100 ELISA (K050662) _Inova Diagnostics, Inc. · NUM · Jun 13, 2005 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM/K050662 ## Device Facts - **Applicant:** Inova Diagnostics, Inc. - **Product Code:** [NUM](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM.md) - **Decision Date:** Jun 13, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5090 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC). ## Device Story QUANTA Lite™ sp100 is an ELISA-based in vitro diagnostic test. It detects IgG class anti-sp100 antibodies in human serum samples. The assay utilizes enzyme-linked immunosorbent technology to identify specific autoantibodies associated with primary biliary cirrhosis (PBC). The test is performed in a clinical laboratory setting by trained laboratory personnel. Results are provided to clinicians to assist in the diagnostic workup of patients suspected of having PBC. The device provides semi-quantitative data, which clinicians interpret alongside clinical symptoms and other laboratory findings to support a diagnosis. ## Clinical Evidence No clinical data provided in the summary document. Substantial equivalence is based on bench testing and performance characteristics typical of ELISA-based diagnostic assays. ## Technological Characteristics Semi-quantitative ELISA. Materials: polystyrene microwell plates, purified sp100 peptide antigen, goat anti-human IgG HRP conjugate, TMB chromogen. Energy source: spectrophotometer (450nm/620nm). Manual/automated plate reader required. No specific connectivity or software algorithm class defined beyond standard spectrophotometric data processing. ## Regulatory Identification An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver). ## Predicate Devices - QUANTA Lite™ gp210 ELISA (k040885) ## 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. Public Health Service JUN 1 3 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 INOVA Diagnostics, Inc. c/o Dr. Gary L. Norman 10180 Scripps Ranch Blvd. San Diego, CA 92131 Re: k050662 Trade/Device Name: QUANTA Lite™ sp100 ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Antimitochondrial Antibody Immunological Test System Regulatory Class: Class II Product Code: NUM Dated: March 11, 2005 Received: March 29, 2005 Dear Dr. Norman: 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. 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 legally {1}------------------------------------------------ Page 2 – Dr. Gary L. Norman 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), please contact the Office of Compliance at (240) 276-0131. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Robert H. Becker/ Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page _________________________________________________________________________________________________________________________________________________________________________ # 510(k) Number (if known): K050662 ### Device Name: QUANTA Lite™ sp100 ELISA # Indications For Use: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC). #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ # Concurrence of CDRH, Office of Device Evaluation (ODE) Mana Chen ______________________________________________________________________________________________________________________________________________________________________________ Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ Ko-50662) ============================================================================================================================================================ Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM/K050662](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM/K050662) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com