# K992834: Gem Premier 3000

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 24, 1999 after 93 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801848 (1980). 6 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K963800: IL Synthesis, Instrumentation Laboratory CO (1996) Summary page 1.
- (no number) manual spun hematocrit: named in the summary without a submission number

## Most influential descendants
- K022158: Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product) (2002), 17 descendants of its own
- 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

## Recalls of this device
- Sep 29, 2023 · Class II · Z-0357-2024: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside
- Sep 29, 2023 · Class II · Z-0358-2024: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside
- Sep 29, 2023 · Class II · Z-0359-2024: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside
- Mar 7, 2003 · Not classified · Z-0846-03: Incorrect bar code applied to cartridges could result in inaccurate pO2 value
- Mar 7, 2003 · Not classified · Z-0845-03: Incorrect bar code applied to cartridges could result in inaccurate pO2 value

## Indications for use
The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), 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,, pO,, Na+, K+, Ca++, and Het. These parameters along with derived parameters Base Excess, HCO;, TCO, and sO, 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/K992834
Methodology: https://510kreport.com/methodology