← Product Code [DFC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC) · K994110 # LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K994110) _Diasorin/American Standard Companies · DFC · Dec 21, 1999 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFC/K994110 ## Device Facts - **Applicant:** Diasorin/American Standard Companies - **Product Code:** [DFC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC.md) - **Decision Date:** Dec 21, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5600 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use FOR IN VITRO DIAGNOSTIC USE. The SPQ™ Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations. ## Device Story The SPQ™ III Antibody Reagent Set is an in vitro diagnostic test kit for the quantitative measurement of human lipoprotein(a) in serum. The device utilizes immunoprecipitin analysis performed on a turbidimetric clinical analyzer (specifically the Hitachi 911). The system measures turbidity changes resulting from antigen-antibody reactions to determine Lp(a) concentration in mg/dL. It is intended for use by clinical laboratory professionals to assist in lipid metabolism disorder evaluation and CHD risk assessment. The output is a quantitative value used by clinicians in conjunction with other patient data to inform clinical decision-making. ## Clinical Evidence Bench testing with clinical samples was performed to validate the performance of the modified device on the Hitachi 911 analyzer. Results demonstrated that the performance characteristics are substantially equivalent to the predicate device. ## Technological Characteristics Immunoprecipitin analysis; turbidimetric measurement; reagent set for use on clinical chemistry analyzers (e.g., Hitachi 911). ## Regulatory Identification A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases. ## Predicate Devices - SPQ™ III Antibody Reagent Set for Lipoprotein(a) ## 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}------------------------------------------------ # TEC 2 | BB ## Special 510(k): Device Modification: Lp(a) SPQ™ III Antibody Reagent Set #### 510(k) Summary 10 K994110 December 3, 1999 | Submitted By: | Judith J. Smith
DiaSorin, Inc.
Quarry Park Place, Suite 100
9175 Guilford Road
Columbia, MD 21046 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | December 3, 1999 | | | Name Of Device: | | | Trade Name: | Lipoprotein(a) SPQ TM III Antibody Reagent Set | | Common Name: | Lipoprotein(a) Immunological Test Kit | | Classification Name: | Lipoprotein(a), antigen, antiserum, control (82DFC) | | Device Classification | Class II | | Predicate Device: | SPQ TM III Antibody Reagent Set for Lipoprotein(a) | | Device Description: | Lipoprotein(a) Immunological Test Kit | | Intended Use: | FOR IN VITRO DIAGNOSTIC USE.
The SPQ TM Antibody Reagent Set for Lp(a) is designed for the
quantitative determination of human lipoprotein(a) in mg/dL in
human serum by immunoprecipitin analysis using a turbidimetric
clinical analyzer. The measurement of Lp(a) is indicated for use in
conjunction with clinical evaluation, patient risk assessment and
other lipoprotein tests to evaluate disorders of lipid metabolism and
to assess coronary heart disease (CHD) in male Caucasian
populations. | | Technological
Comparison: | The modified device has the same technological basis as the
predicate device. | - Labeling Comparison: The labeling of the modified device is substantially equivalent to that of the predicate device. Changes in the labeling and package insert directly reflect the device modification (the additional instrument application for the Hitachi 911). {1}------------------------------------------------ | Bench Testing
With Clinical Samples: | Bench testing with clinical samples demonstrated that the
performance characteristics of the modified device were
substantially equivalent to those of the predicate device. | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusions from
Testing: | The modified device is substantially equivalent to the predicate
device. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles arranged in a cascading manner, resembling a series of waves or flowing lines. BEC 2 | 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Judith J. Smith Vice President, Worldwide Regulatory Affairs and Quality Systems Diasorin/American Standard Companies 9175 Guilford Road, Suite 100 Quarry Park Place Columbia, Maryland 21046 Re: K994110 > Trade Name: SPO™ III Test System Antibody Reagent Set for Lp(a) Regulatory Class: II Product Code: DFC Dated: December 3, 1999 Received: December 6, 1999 Dear Ms. Smith: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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 (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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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 {4}------------------------------------------------ # 4 Intended Use/Indications For Use 510(k) Number: K994110 Device Name: SPQ™ III Test System Antibody Reagent Set for Lp(a) Intended Use/Indications For Use: ### FOR IN VITRO DIAGNOSTIC USE. The SPQ™ Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations. L (Division Sign-Off) Division of Clinical Laboratory Devices Cooper 510(k) Number 1994110 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ﺳﮯ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔ Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFC/K994110](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DFC/K994110) **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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