← Product Code [DHR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR) · K960987 # LIQUICHEK RHEUMATOID FACTOR CONTROL (K960987) _Bio-Rad · DHR · Jun 4, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K960987 ## Device Facts - **Applicant:** Bio-Rad - **Product Code:** [DHR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR.md) - **Decision Date:** Jun 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5775 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies. ## Device Story Liquichek Rheumatoid Factor Control; human serum-based quality control material; used to monitor precision of laboratory rheumatoid factor testing methodologies; provides trilevel product for multi-point calibration/verification; stored at 2-8°C; used by laboratory personnel to ensure assay performance; assists in clinical decision-making by validating test accuracy. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Human serum matrix; trilevel product configuration; storage at 2-8°C. No specific materials or software algorithms described. ## Regulatory Identification A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. ## Predicate Devices - Liquichek Rheumatoid Factor Control ([K923578](/device/K923578.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} BIO-RAD Bio-Rad Laboratories ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 # 510(k) Summary K960987 JUN - 4 1996 ## Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383 ## Contact Persons Elizabeth Platt ## Date of Summary Preparation May 2, 1996 ## Device (Trade & Common Name) Liquichek Rheumatoid Factor Control ## Classification Name Class II CFR 866.5775, Rheumatoid Factor Immunological Test System 82DHR ## Devices to Which Substantial Equivalence is Claimed Liquichek Rheumatoid Factor Control K923578 ## Statement of Intended Use Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies. ## Description of the Device Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin. {1} BIO-RAD Bio-Rad Laboratories ECS Division 3726 E. Miratoma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 # Statement of How Technological Characteristics Compare to Substantial Equivalence Device A table is provided below comparing the technological characteristics between Liquichek Rheumatoid Factor Control and the original device to which substantial equivalence is claimed. | | Liquichek Rheumatoid Factor Control (original submission) | Liquichek Rheumatoid Factor Control (additional information submitted in 1996) | | --- | --- | --- | | Intended Use | assayed control for rheumatoid factor testing methodologies | assayed control for rheumatoid factor testing methodologies | | Matrix | Human Serum | Human Serum | | Product Levels | single level product | trilevel level product (two additional levels added) | | Storage | 2-8°C | 2-8°C | --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K960987](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K960987) **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