← Product Code [LAN](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN) · K955422 # AXSYM N-ACETYLPROCAINAMIDE (K955422) _Abbott Laboratories · LAN · Apr 24, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN/K955422 ## Device Facts - **Applicant:** Abbott Laboratories - **Product Code:** [LAN](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN.md) - **Decision Date:** Apr 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3320 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The intended use of both assays is for the quantitative determination of N-acetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate). ## Device Story Automated fluorescence polarization immunoassay (FPIA) for quantitative measurement of N-acetylprocainamide in human serum or plasma; used on AxSYM system; intended for clinical laboratory use; provides concentration data to clinicians for therapeutic drug monitoring; calibrators and controls used for system verification; performance validated via correlation with predicate TDx/TDxFLx assay. ## Clinical Evidence Correlation study comparing AxSYM N-Acetylprocainamide to predicate TDx/TDxFLx assay; n=205 samples; results: slope 1.05, y-intercept -0.1, correlation coefficient 0.993, standard error of Y estimate 0.081. ## Technological Characteristics Automated fluorescence polarization immunoassay (FPIA); utilizes Abbott AxSYM system; reagents, calibrators, and controls prepared gravimetrically; real-time stability testing for expiration dating. ## 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 - TDx/TDxFLx N-Acetylprocainamide 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} K955422 APR 24 1996 510(k) Summary Abbott AxSYM N-Acetylprocainamide Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination The following information as presented in the Premarket Notification 510(k) for AxSYM N-Acetylprocainamide constitutes data supporting a substantially equivalent determination. Substantial equivalence has been demonstrated between the AxSYM N-Acetylprocainamide assay and the TDx/TDxFLx N-Acetylprocainamide assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of N-acetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate). Both assays are calibrated with Abbott calibrators. Abbott controls are assayed controls used for verification of the accuracy and precision of the AxSYM system. Correlation studies indicated the following results: Slope: 1.05 Y-Intercept: -0.1 Correlation Coefficient: 0.993 Std. Error of the Y estimate: 0.081 Number: 205 The AxSYM N-Acetylprocainamide standard calibrators and controls are to be used with the AxSYM N-Acetylprocainamide 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 N-Acetylprocainamide reagent, calibrator and control expiration dates are based on real time stability testing. Prepared and Submitted : Grace LeMieux (708) 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/LAN/K955422](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN/K955422) **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