510(k) · Cleared
ClearedTrilogy Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drew Scientific, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jul 13, 2007 as substantially equivalent to K851172 (Roche Diagnostic Systems, Inc., 1985) and 4 other predicates after a 122-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jul 13, 2007
- Review
- 122 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K851172 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK851172 Cobas MiraRoche Diagnostic Systems, Inc. · 1985
- This deviceK070704 Trilogy AnalyzerDrew Scientific, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851172 | Cobas Mira | Roche Diagnostic Systems, Inc. | 1985 | — |
| 0 (this device) | K070704 | Trilogy Analyzer | Drew Scientific, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K851172 | Cobas MiraSummary page 1…Discrete) for Clinical Use 3. PREDICATE DEVICES * Roche Diagnostic Systems, Inc. Roche COBAS MIRA® Chemistry System (K851172) * Medica Corp. EasyElectrolytes Analyzer (K000926) * JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent (KO… | 1985 |
| * | K000926 | Easyelectrolyte Analyzer and Rapidlyte AnalyzerSummary page 1…Use 3. PREDICATE DEVICES * Roche Diagnostic Systems, Inc. Roche COBAS MIRA® Chemistry System (K851172) * Medica Corp. EasyElectrolytes Analyzer (K000926) * JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent (KO I1900) * JAS Diagnostics, Inc. Creatinine (Single… | 2000 |
| * | K011900 | Glucose (Hexokinase) | 2001 |
| * | K003247 | CreatinineSummary page 1…rolytes Analyzer (K000926) * JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent (KO I1900) * JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent (K003247) * JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent (KO1 1596) Drew Scientific, Inc. J… | 2000 |
| * | K011596 | Urea Nitrogen (Bun) Liquid Reagent | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K851172.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (172 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070704: Trilogy Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026