← Product Code [DHN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHN) · K024221 # LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 (K024221) _Bio-Rad · DHN · Jan 15, 2003 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHN/K024221 ## Device Facts - **Applicant:** Bio-Rad - **Product Code:** [DHN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHN.md) - **Decision Date:** Jan 15, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5100 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The Liquichek ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA). ## Device Story Liquichek ANA Control is a liquid, human serum-based quality control material. It is used by laboratory personnel to monitor the performance of indirect immunofluorescent (IIF) assays for antinuclear antibodies. The control provides a known homogeneous pattern to verify the accuracy and reliability of the testing process. By comparing the observed results of the control against expected performance, clinicians ensure the validity of patient sample testing. The device is stored at 2-8°C and features a 60-day open-vial stability. ## Clinical Evidence Bench testing only. Stability studies were conducted to establish shelf life (2 years unopened at 2-8°C) and open-vial stability (60 days at 2-8°C). No clinical data was required or provided. ## Technological Characteristics Human serum matrix with added preservatives. Liquid form. Storage at 2-8°C. Analyte: ANA Homogeneous Pattern. No software or electronic components. ## Regulatory Identification An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). ## Predicate Devices - Kallestad™ ANA Positive Control Homogeneous Pattern ([K792610](/device/K792610.md)) ## 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}------------------------------------------------ JAN 1 5 2003 K024221 # Summary of Safety and Effectiveness Liquichek™ ANA Control Homogeneous Pattern, Positive #### 1.0 Submitter Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555 ### Contact Person Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465 ## Date of Summary Preparation December 20, 2002 #### 2.0 Device Identification | Product Trade Name: | Liquichek™ ANA Control Homogeneous Pattern,
Positive | |---------------------|-----------------------------------------------------------------------| | Common Name: | Antinuclear Antibody, Indirect Immunofluorescent,
Antigen, Control | | Classifications: | Class II | | Product Code: | 82DHN | | Regulation Number: | 21 CFR 866.5100 | #### Device to Which Substantial Equivalence is Claimed 3.0 Kallestad ™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories 510 (k) Number: K792610 #### 4.0 Description of Device This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience. {1}------------------------------------------------ #### 5.0 Statement of Intended Use The Liquichek ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA). #### 6.0 Comparison of the new device with the Predicate Device This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market: Kallestad™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories 510 (k) Number: K792610 Table 1. Similarities and Differences between new and predicate device. | Characteristics | Liquichek™ ANA Control
Homogeneous Pattern, Positive | Kallestad™ ANA Positive Control
Homogeneous Pattern | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (New Device) | (Predicate Device) | | Similarities | | | | Intended Use | The Liquichek ANA Control,
Homogeneous Pattern, Positive,
is intended for use as an
unassayed quality control to
monitor indirect
immunofluorescent testing of
antinuclear antibodies (ANA). | The intended use of the ANA
Positive Control Homogeneous
Pattern is the quality control of
indirect fluorescent antibody
procedures for the detection and
semi-quantitation of human
autoantibodies to nuclear antigens
(ANA). | | Matrix | Human Serum | Human Serum | | Storage
(Unopened) | 2°C to 8°C
until expiration date | 2°C to 8°C
until expiration date | | Analyte | ANA Homogeneous Pattern | ANA Homogeneous Pattern | | Form | Liquid | Liquid | | Differences | | | | Stability
(Opened) | Once opened the analyte will be
stable for 60 days. | No claim for stability | {2}------------------------------------------------ #### 7.0 Summary of Performance Data Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control Homogeneous Pattern, Positive. Product claims are as follows: - 7.1 Once the control is opened the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C. - 7.2 The control is stable for 2 years when stored unopened at 2 8°C. Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is black and white. JAN 1 5 2003 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017 Re: k024221 > Trade/Device Name: Liquichek™ ANA Control Homogeneous Pattern, Positive Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: DHN Dated: December 20, 2002 Received: December 23, 2002 Dear Ms. Lloyd: 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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {4}------------------------------------------------ ### Page 2 - 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 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510 (k) Number (if known): K02 422 | Device Name: Liquichek™ ANA Control Homogeneous Pattern, Positive Indications for Use: The Liquichek ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA). (PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use or Over-the Counter use__________________________________________________________________________________________________________________________________________________________ J. Reeves for J. Bautista Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number_ << 0 2 4 2 4 2 2 | --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHN/K024221](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHN/K024221) **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