# K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 15, 2006 after 65 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801848 (1980). 10 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052121: Gem Premier 3000, Instrumentation Laboratory CO (2005) Summary page 2.
- K963800: IL Synthesis, Instrumentation Laboratory CO (1996) Summary page 2.
- K945677: IL682, CO-Oximeter, Instrumentation Laboratory CO (1995) Summary page 2.

## Most influential descendants
- 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
- K173403: GEM Premier 5000 (2017), 2 descendants of its own
- K160225: GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (2016), 2 descendants of its own

## Recalls of this device
- May 31, 2011 · Not classified · Z-2806-2011: K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL
- May 31, 2011 · Not classified · Z-2805-2011: K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL
- May 31, 2011 · Not classified · Z-2803-2011: K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL
- Mar 27, 2007 · Not classified · Z-0778-2007: Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

## Indications for use
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, PO2, Na +, K +, CI-, Ca ++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O 2Hb, COHb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is 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 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; 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.

Source page: https://510kreport.com/device/K061974
Methodology: https://510kreport.com/methodology