← Product Code [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM) · K963158 # ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158) _Abbott Laboratories · LFM · Sep 10, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K963158 ## Device Facts - **Applicant:** Abbott Laboratories - **Product Code:** [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3300 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The Abbott AxSYM Digitoxin assay is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate). ## Device Story Automated fluorescence polarization immunoassay (FPIA) for quantitative digitoxin measurement in human serum or plasma; utilizes Abbott AxSYM system; calibrators and controls used for accuracy/precision verification; results used by clinicians to monitor therapeutic drug levels; provides quantitative output for clinical decision-making. ## Clinical Evidence Correlation study comparing AxSYM Digitoxin to predicate (TDx/TDxFLx). Sample size n=517. Results: slope 0.96, y-intercept 0.58, correlation coefficient 0.97, standard error of Y estimate 1.87. ## Technological Characteristics Automated fluorescence polarization immunoassay (FPIA). Uses Abbott AxSYM system instrumentation. Reagents, calibrators, and controls prepared gravimetrically from purified materials. Stability verified via real-time testing. ## Regulatory Identification A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. ## Predicate Devices - TDx/TDxFLx Digitoxin assay ## 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} K963158 SEP 10 1996 510(k) Summary Abbott AxSYM® Digitoxin Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination The Abbott AxSYM Digitoxin assay is substantially equivalence to the TDx/TDxFLx Digitoxin assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate). Both assays are calibrated with Abbott calibrators. Abbott controls are used for verification of accuracy and precision of the AxSYM system when used for the quantitative determination of digitoxin in human serum or plasma. Correlation studies indicated the following results: Slope: 0.96 Y-intercept: 0.58 Correlation Coefficient: 0.97 Std. Error of the Y estimate: 1.87 Number: 517 The AxSYM Digitoxin standard calibrators and controls are to be used with the AxSYM Digitoxin reagents. The calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources. The calibrators and controls are verified using protocols involving multiple instrument testing. AxSYM Digitoxin reagent, calibrator and control expiration dates are based on real time stability testing. Prepared and Submitted: Grace LeMieux (847) 937-0165 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K963158](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K963158) **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