# K052121: Gem Premier 3000

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 21, 2005 after 77 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801848 (1980). 9 ancestors in all.
16 later devices descend from it; 2 cite 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)
- K022158: Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product), Instrumentation Laboratory CO (2002) Summary page 1.

## Most influential descendants
- 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
- K173403: GEM Premier 5000 (2017), 2 descendants of its own

## Recalls of this device
- May 11, 2011 · Not classified · Z-2673-2011: Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.
- Dec 16, 2005 · Not classified · Z-0378-06: Software error may report higher results for glucose and lactate

## Indications for use
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO 2, PO2, Na+, K+, Ca++, Glucose, Lactate and Het. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

Source page: https://510kreport.com/device/K052121
Methodology: https://510kreport.com/methodology