# K963800: IL Synthesis

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 13, 1996 after 51 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801848 (1980). 5 ancestors in all.
20 later devices descend from it; 3 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)
- K890827: IL1400, Bgelectrolyte Analyzer, Instrumentation Laboratory CO (1989) Summary page 2.
- K935069: IL1430 Bgelectrolyte Analyzer, Instrumentation Laboratory CO (1994) Summary page 2.
- K955793: IL Bgge Blood Gas with Glucose System, Instrumentation Laboratory CO (1996) Summary page 2.
- K945677: IL682, CO-Oximeter, Instrumentation Laboratory CO (1995) Summary page 2.
- K801848: ICA1 Ionized Calcium Analyzer, The London Co. (1980) Summary page 2.

## Most influential descendants
- K992834: Gem Premier 3000 (1999), 18 descendants of its own
- 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

## Indications for use
The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (Cl-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selective electrode (ISE) potentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu). The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O2Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O2ct), oxygen binding capacity (O2cap) and oxygen saturation (sO2).

Source page: https://510kreport.com/device/K963800
Methodology: https://510kreport.com/methodology