← Product Code [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK) · K962373 # N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 (K962373) _Behring Diagnostics, Inc. · DCK · Jul 11, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K962373 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK.md) - **Decision Date:** Jul 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5270 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively. In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively. ## Device Story N/T Rheumatology Controls SL1/2 are multi-constituent, bi-level liquid quality control materials. Used in clinical laboratories to monitor accuracy of nephelometric and turbidimetric assays (ASL, CRP, RF, ADNase B) on Behring Nephelometer (BN), BN-100, and Behring TurbiTimeSystem (TTS). Replaces individual lyophilized controls with a single-vial, multi-constituent liquid format. Healthcare providers use control results to verify assay performance and ensure accuracy of patient test results. ## Clinical Evidence Bench testing only. Accuracy studies performed on three Behring Nephelometers using two lots of controls and three lots of N Latex CRP mono reagent. Replicates of five. Percent recovery compared to assigned values ranged from 92.1% to 107.2%. ## Technological Characteristics Multi-constituent, bi-level liquid control serum. Designed for use with Behring Nephelometer (BN), BN-100, and Behring TurbiTimeSystem (TTS). ## Regulatory Identification A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. ## Predicate Devices - N/T CRP Control Serum - N/T RF Control Serum - N/T ASL Control Serum ## 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} JUL 11 1996 K962373 # 510(k) Summary of Safety and Effectiveness for N/T Rheumatology Controls SL1/2 1. Manufactures Name, Address, Telephone, and contact person, date of preparation: Manufacture Behringwerke AG Postfach 1140 35001 Marburg Germany Distributor Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3000 Attn: Kathleen Dray-Lyons Preparation date: June 19, 1996 2. Device Name/ Classification: N/T Rheumatology Control SL1/2: Quality Control Material (assayed) Classification Number: class I (862.1660) 3. Identification of the legally marketed device: N/T CRP, RF, and ASL Control Serum 4. Proposed Device Description: N/T Rheumatology Controls SL (bi-level control; N/T Rheumatology Control SL/1 and N/T Rheumatology Control SL/2) is a multi-constituent control intended for use as a quality control material to monitor the accuracy of selected rheumatic and inflammatory disease with the Behring Nephelometer (BN), Behring Nephelometer 100 (BN-100) and the Behring TurbiTimeSystem® (TTS). 5. Proposed Device Intended Use: Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively. In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively. 000009 {1} 6. Medical device to which equivalence is claimed and comparison information: The N/T Rheumatology Controls SL are substantially equivalent in intended use to the individual N/T CRP Control Serum, N/T RF Control Serum and N/T ASL Control Serum. All products are *in vitro* diagnostic reagents intended for use as a quality control material to monitor the accuracy of certain immunology procedures. The N/T Rheumatology Controls SL, however, eliminates using three separate controls since all three constituents are included in one vial. The N/T Rheumatology Controls SL differ from the N/T CRP Control Serum, N/T RF Control Serum and N/T ASL Control Serum in that the N/T Rheumatology Controls SL are liquid while the individual controls are lyophilized and the N/T Rheumatology Controls SL are bi-level while the individual controls are single-level. 7. Proposed Device Performance Characteristics: Accuracy studies using multiple vials of the controls were run on three Behring Nephelometers. Two lots of each control were tested. Three lots of N Latex CRP mono reagent were assayed in replicates of five on the Behring Nephelometers. The mean values and the percent recovery from the assigned values were calculated for each parameter. The percent recoveries compared to assigned values ranged from 92.1 to 107.2% 000010 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K962373](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K962373) **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