← Product Code [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH) · K964587 # VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM (K964587) _Bayer Corp. · LEH · Jan 13, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K964587 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH.md) - **Decision Date:** Jan 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3950 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use This in vitro method is intended to quantitatively measure vancomycin, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycin Assay on a Technicon Immuno-1® system. Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. ## Device Story In vitro diagnostic assay for quantitative measurement of vancomycin in human serum or plasma; performed on Technicon Immuno-1® system. Utilizes Syva EMIT® Vancomycin Assay reagents/calibrators. Used by clinical laboratory personnel to monitor antibiotic levels for therapeutic management and overdose diagnosis. Output is a concentration value (μg/mL) used by clinicians to adjust dosing regimens. ## Clinical Evidence Bench testing only. Comparison study performed against Syva EMIT® Vancomycin Assay (n=53). Precision evaluated at multiple concentrations (8.5, 39.5, 50.6 μg/mL) with between-run CVs ranging from 5.3% to 6.6%. Minimum detectable concentration reported as 0.2 μg/mL. ## Technological Characteristics In vitro diagnostic reagent kit for automated chemistry analyzer. Principle: EMIT (Enzyme Multiplied Immunoassay Technique). Form factor: Liquid reagents and calibrators for Technicon Immuno-1® system. ## Regulatory Identification A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy. ## Predicate Devices - Syva EMIT® Vancomycin Assay (Behring Diagnostics Inc.) ## Reference Devices - Technicon RA-1000® 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} JAN 08 '97 09:49AM CLIN MED & REG AF P.2/2 JAN 13 1997 K964587 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Vancomycin Method for Bayer Technicon Immuno 1® System Listed below is a comparison of the performance between the Immuno 1 Vancomycin method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Vancomycin Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Vancomycin method sheet and the Syva EMIT® Vancomycin Assay Insert Sheet. ## INTENDED USED This *in vitro* method is intended to quantitatively measure vancomycin, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycin Assay on a *Technicon Immuno-1®* system. Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. | METHOD | Immuno 1 Vancomycin | | Syva EMIT® Vancomycin (predicate Device) | | | --- | --- | --- | --- | --- | | Part No. | Reagents T01-3705-01 | | Reagents 6W419UL | | | | Calibrators T03-3714-01 | | Calibrators 6W519UL | | | Minimum Detectable Conc. | 0.2 μg/mL | | Not Listed | | | Precision (Between-Run) | 8.5 μg/mL 5.3% | | 7.2 μg/mL 10.3% | | | | 39.5 μg/mL 6.6% | | 38.7 μg/mL 5.6% | | | | 50.6 μg/mL 5.3% | | 39.5 μg/mL 6.2% | | | Correlation | y = 1.032 x - 0.006 | | | | | | where | | | | | | y = Immuno 1 Vancomycin method | | | | | | x = Syva EMIT® Vancomycin Assay+ | | | | | | n = 53 | | | | | | r = 0.981 | | | | | | S_{yx} = 1.779 μg/mL | | | | | | *This assay was performed on Technicon RA-1000® Instrument using parameters and protocol specified in Behring Application Sheet. | | | | Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K964587](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K964587) **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