# K972861: IL Test Contril Spectrum (Levels 1, 2 and 3)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 19, 1997 after 15 days
- Product code: JJS (Controls For Blood-Gases, (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 7 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.
- K945677: IL682, CO-Oximeter, Instrumentation Laboratory CO (1995) Summary page 1.

## Indications for use
IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

Source page: https://510kreport.com/device/K972861
Methodology: https://510kreport.com/methodology