← Product Code [KXT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT) · K963062 # IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 (K963062) _Beckman Instruments, Inc. · KXT · Dec 13, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K963062 ## Device Facts - **Applicant:** Beckman Instruments, Inc. - **Product Code:** [KXT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT.md) - **Decision Date:** Dec 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3320 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plasma samples by turbidimetric immunoassay. This assay is designed for use with the IMMAGE Immunochemistry System. ## Device Story IMMAGE Immunochemistry System Digoxin (DIG) Reagent performs quantitative determination of digoxin in human serum and plasma. Device utilizes turbidimetric inhibition immunoassay technology; operates at 37°C. System requires no sample pretreatment. Used in clinical laboratory settings by trained personnel. Output is a quantitative concentration value (ng/mL) used by clinicians to monitor digoxin levels. Benefits include automated, efficient measurement compared to predicate fluorescence polarization methods. ## Clinical Evidence Bench testing only. Performance demonstrated via method comparison against Abbott TDx Digoxin II Reagent using Deming regression (slope 1.011 ± 0.037, intercept 0.047 ± 0.0016, r=0.978). Within-run imprecision evaluated across three levels (0.87, 2.63, 4.19 ng/mL) with CVs ranging from 2.3% to 5.1%. Stability studies confirm 18-month shelf-life and 14-day on-board stability for reagent. ## Technological Characteristics Turbidimetric inhibition immunoassay; operates at 37°C. Analytical range 0.2 to 5 ng/mL. Designed for use on the IMMAGE Immunochemistry System. Reagent shelf-life 18 months; 14-day on-board stability. ## 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 - Behring Diagnostics N Latex RF ([K942328](/device/K942328.md)) - Abbott TDx Digoxin II Reagent ([K882233](/device/K882233.md)) ## 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} FROM : BECKMAN INSTRUMENTS 714 961 4457 1996, 12-04 16:01 #757 P.02/05 200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • (714) 993-8321 # BECKMAN Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent ## 1.0 Submitted By: K963062 Sheri Hall Manager, Premarket Regulatory Margie George Project Manager, Systems Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759 DEC 13 1996 ## 2.0 Data Submitted: 04 December 1996 ## 3.0 Device Name(s): ### 3.1 Proprietary Names IMMAGE™ Immunochemistry System Digoxin Reagent Beckman Drug Calibrator 2 ### 3.2 Classification Names Digoxin immunological test system (21 CFR 866.5775) Clinical toxicology calibrator (21 CFR 862.3200) ## 4.0 Predicate Device(s): Behring Diagnostics N Latex RF, K942328 Abbott TDx Digoxin II Reagent, K882233 ## 5.0 Description: The IMMAGE System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of digoxin concentrations in human serum and plasma samples. ## 6.0 Intended Use: The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plasma samples by turbidimetric immunoassay. This assay is designed for use with the IMMAGE Immunochemistry System. file: ir510k_2.eaa Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent Beckman Instruments, Inc. bnc 910-502-1360 • telex: 06-78413 {1} FROM :BECKMAN INSTRUMENTS 714 961 4457 1996,12-04 16:02 #767 P.03/05 ## 7.0 Comparison to Predicate(s): The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | Reagent | Reagents/Compounds | Comments | | --- | --- | --- | | DIG Reagent | Intended use for the measurement of digoxin at 37°C | Same as TDx Digoxin II Reagent | | | Reagent measures digoxin in both human plasma and serum samples | Same as TDx Digoxin II Reagent | | | Analytic Range of 0.2 to 5 ng/mL | Same as TDx Digoxin II Reagent | | DIFFERENCES | | | | DIG Reagent | Assay Type | IMMAGE System DIG Reagent uses turbidimetric inhibition immunoassay technology while the predicate uses fluorescence polarization immunoassay technology | | | Sample Pretreatment | IMMAGE System DIG Reagent does not require sample pretreatment while the predicate requires sample pretreatment | ## 8.0 Summary of Performance Data: The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Abbott Digoxin II Reagent to the IMMAGE DIG Reagent. ### Method Comparison Study Results* IMMAGE DIG Reagent vs. Abbott Digoxin II Reagent | Analyte | Sample | Method | Pre-Test | Predicate | | --- | --- | --- | --- | --- | | IMMAGE DIG | 1.011 ± 0.037 | 0.047 ± 0.0016 | 0.978 | Abbott TDx Digoxin II | *Deming regression analysis ### Stability Study Results | Reagent | Reagent Product Claim | | --- | --- | | IMMAGE DIG | 18 months shelf-life 14-day on board | | Drug Calibrator 2 | 24 months shelf-life 14-day calibration | file: ir610k_2.ssa Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent {2} FROM : BECKMAN INSTRUMENTS 714 961 4457 1996, 12-04 16:02 #767 P.04/05 # Estimated Within-Run Imprecision | Material | MEAS (R/mL) | SD (R/mL) | VCV | Number of Results | | --- | --- | --- | --- | --- | | Level 1 | 0.87 | 0.042 | 4.8 | 15 | | Level 1 | 1.32 | 0.088 | 5.1 | 80 | | Level 2 | 2.63 | 0.079 | 3.0 | 80 | | Level 3 | 4.19 | 0.095 | 2.3 | 80 | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. file: ir610k_2.exe Beckman Instruments, Inc., Section 610(k) Notification IMMAGE™ Immunochorimetry System Digoxin (DIG) Reagent --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K963062](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K963062) **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