# K070704: Trilogy Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Drew Scientific, Inc.
- Decided: Jul 13, 2007 after 122 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K851172 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851172: Cobas Mira, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K000926: Easyelectrolyte Analyzer and Rapidlyte Analyzer, Medica Corp. (2000) Summary page 1.
- K011900: Glucose (Hexokinase), Jas Diagnostics, Inc. (2001)
- K003247: Creatinine, Jas Diagnostics, Inc. (2000) Summary page 1.
- K011596: Urea Nitrogen (Bun) Liquid Reagent, Jas Diagnostic, Inc. (2001)

## Indications for use
TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.

Source page: https://510kreport.com/device/K070704
Methodology: https://510kreport.com/methodology