# K022158: Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 10, 2002 after 70 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801848 (1980). 8 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010520: Gem Premier 3000- Addition of Glucose and Lactate as New Parameters, Instrumentation Laboratory CO (2001) Summary page 1.
- K992834: Gem Premier 3000, Instrumentation Laboratory CO (1999) Summary page 1.

## Most influential descendants
- K052121: Gem Premier 3000 (2005), 16 descendants of its own
- K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit (2006), 14 descendants of its own
- K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to (2010), 12 descendants of its own
- K112995: Gem Premier 4000 (2012), 11 descendants of its own
- K133407: Gem Premier 4000 (2014), 10 descendants of its own

## Indications for use
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520. Intelligent Quality Management (iQM) is being introduced on the GEM Premier 3000 as an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. As part of this program, GEM CVP (Calibration Validation Product) is intended for the external verification of the iQM cartridge calibration after initial warm-up to ensure its integrity. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes and metabolites; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life. To ensure that a total quality management system is adhered to, laboratories should follow local, state and federal regulatory guidelines. As with any analytical device or computer software, there is always the potential for software failure. However, IL conducts rigorous testing and extensive software validation prior to releasing a software revision. If the user encounters a rare software error code, it should be reported to your local IL Technical Support Representative.

Source page: https://510kreport.com/device/K022158
Methodology: https://510kreport.com/methodology