← Product Code [LBZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LBZ) · K964116 # QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116) _Bayer Corp. · LBZ · Dec 24, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LBZ/K964116 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [LBZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LBZ.md) - **Decision Date:** Dec 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3320 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use This in vitro method is intended to quantitatively measure Quinidine, an anti-arrhythmic drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-1® system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy. ## Device Story In vitro diagnostic assay for quantitative measurement of quinidine in human serum or plasma; utilizes Technicon Immuno-1® system; intended for clinical laboratory use by trained personnel; provides serum concentration data to clinicians for therapeutic drug monitoring and overdose assessment; aids in optimizing anti-arrhythmic drug therapy. ## Clinical Evidence Bench testing only. Comparison of Immuno 1 Quinidine method against Syva EMIT® 2000 predicate. Precision evaluated at 1.2, 3.5, and 6.0 μg/mL concentrations with CVs of 5.5%, 4.8%, and 5.3% respectively. Correlation study (n=25) yielded r=0.991, slope 1.02, intercept -0.16. Minimum detectable concentration 0.06 μg/mL. ## Technological Characteristics In vitro diagnostic reagent system for use on Technicon Immuno-1® automated analyzer. Quantitative immunoassay principle. Reagents and calibrators provided for serum/plasma analysis. ## Regulatory Identification A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. ## Predicate Devices - Syva EMIT® 2000 Quinidine Assay (Behring Diagnostics Inc.) ## Reference Devices - Roche COBAS FARA II® Instrument ## 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} K964116 DEC 24 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Quinidine Method for Bayer Technicon Immuno 1® System Listed below is a comparison of the performance between the Immuno 1 Quinidine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Quinidine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Quinidine method sheet and the Syva EMIT® 2000 Quinidine Assay insert. ## INTENDED USED This *in vitro* method is intended to quantitatively measure Quinidine, an anti-arrhythmic drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a *Technicon Immuno-1®* system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy. | METHOD | Immuno 1 Quinidine | | Syva EMIT® 2000 (predicate Device) | | | --- | --- | --- | --- | --- | | Part No. | Reagents T01-3678-51 | | Reagents | 4Q019UL | | | Calibrators T03-3680-01 | | Calibrators | 4Q109UL | | Minimum Detectable Conc. | 0.06 μg/mL | | 0.25 μg/mL | | | Precision (Between-Run) | 1.2 μg/mL | 5.5% | 1.5 μg/mL | 6.5% | | | 3.5 μg/mL | 4.8% | 3.4 μg/mL | 5.2% | | | 6.0 μg/mL | 5.3% | 5.7 μg/mL | 5.6% | | Correlation | y = 1.02x - 0.16 | | | | | | where y = Immuno 1 Quinidine method | | | | | | x = Syva EMIT® 2000 Quinidine Assay* | | | | | | n = 25 | | | | | | r = 0.991 | | | | | | S_{yx} = 0.148 μg/mL | | | | | *This assay was performed on Roche COBAS FARA II® Instrument. | | | | | Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 *Please Note: Additional # patients requested, DATA provided in 11/26/96 memo. No significant change in correlation. R013. 10/10/96 Date 12/9/96 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LBZ/K964116](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LBZ/K964116) **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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