# K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite

- Pathway: 510(k) (Traditional)
- Applicant: The RX Files Corp.
- Decided: Aug 9, 2001 after 80 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053137: Endotool Drug Dose Calculator (2006), 12 descendants of its own
- K132547: Endo Tool Glucose Management System (Egms) (2014), 8 descendants of its own
- K082512: Intelligent Dosing System for Insulin-MY Insulin Doser (2008), 4 descendants of its own
- K200443: EndoTool IV 1.10 (2020), 3 descendants of its own
- K201619: EndoTool IV System (2020), 2 descendants of its own

## Indications for use
The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx™, InterchangeRx™ and PracticePrescribeRx™. The DoseRx™ is designed for use by trained clinicians to calculate any individual patient’s optimal next dose for any given agent. The InterchangeRx™ is designed to switch a patient from one brand of agent to another while maintaining the therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator that offers graded prescriber training of next dose calculation scenarios with scalable patient response and surrogate marker inputs that allows the healthcare provider to gain guided and measured experience in calculating the next dose for a new or infrequently used drug. The IDS™ is not a substitute for clinical reasoning. The IDS™ is an aid for trained clinicians based upon significant and properly entered data. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

Source page: https://510kreport.com/device/K011571
Methodology: https://510kreport.com/methodology