510(k) · Cleared
ClearedSynermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infrared Laboratory Systems, LLC (Dba Synermed) · CGA Glucose Oxidase, Glucose
Cleared on Jun 24, 2016 as substantially equivalent to K872494 (Boehringer Mannheim Corp., 1987) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jun 24, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872494 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- This deviceK153692 Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| 0 (this device) | K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K872494 | Hitachi 717 Chemistry AnalyzerSummary page 5…chemistry analyzer for clinical use 11. Identification of Predicates: K-number Manufacturer Product K872494 Boehringer Hitachi 717 Mannheim chemistry Corp (Roche) analyzer… | 1987 |
| * | K903063 | Synermed Glucose Reagent KitSummary page 5…Manufacturer Product K872494 Boehringer Hitachi 717 Mannheim chemistry Corp (Roche) analyzer K903063 Synermed Synermed Glucose Reagent 12.… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K872494.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma. The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that…
Read the full statement (107 words)
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random access, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153692: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153692
Report an extraction error
Are you the manufacturer?
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