# K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 18, 2010 after 207 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801848 (1980). 21 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991417: Abl 735 Analyzer, Radiometer America, Inc. (1999) Summary page 1.
- K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit, Instrumentation Laboratory CO (2006) Summary page 1.
- K860942: Quantimetrix Human Bilirubin Control I & II Liquid, Quantimetrix Corp. (1986) Summary page 1.

## Most influential descendants
- 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
- K160415: GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (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
- May 31, 2011 · Not classified · Z-2804-2011: 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
- Feb 14, 2011 · Not classified · Z-2165-2011: Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results

## 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, PCO 2, P02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilimubin and CO-Oximetry (tHb, O2 Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples When analyzed in the tBili/CO-Ox mode. 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. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemnolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus. 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. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP H-ematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL's 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. GEM System Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of pH, PCO2, PO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 analyzer. GEM Hematocrit Evaluator is a three-level assayed quality control material for evaluating performance characteristics of hematocrit on the GEM Premier 4000 analyzer.

Source page: https://510kreport.com/device/K093623
Methodology: https://510kreport.com/methodology