510(k) · Cleared
ClearedGEM Premier ChemSTAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CGA Glucose Oxidase, Glucose
Cleared on Jan 27, 2023 as substantially equivalent to K183549 (Instrumentation Laboratory CO, 2019) and 2 other predicates after a 119-day review. Its family tree reaches back 10 generations to 1980.
- Decided
- Jan 27, 2023
- Review
- 119 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K801848 (1980). 37 ancestors in all, the oldest K790608 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 6 generations between
- 3 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 2 generations backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- 1 generation backK183549 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- This deviceK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
Show all 10 generations
- Root · 10 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 9 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 8 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 7 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 6 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 5 generations backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- 4 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 3 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 2 generations backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- 1 generation backK183549 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- This deviceK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −9 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −8 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −7 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −6 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −5 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| −4 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| −3 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| −2 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| −1 | K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| 0 (this device) | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K183549 | GEM Premier ChemSTATSummary page 5…K223090 Device Trade Name GEM Premier ChemSTAT Predicate Device GEM Premier ChemSTAT K183549, K183546,K183555 Regulatory Information GEM… | 2019 |
| * | K183546 | GEM Premier ChemSTATSummary page 5…K223090 Device Trade Name GEM Premier ChemSTAT Predicate Device GEM Premier ChemSTAT K183549, K183546,K183555 Regulatory Information GEM Premier… | 2019 |
| * | K183555 | GEM Premier ChemSTATSummary page 5…K223090 Device Trade Name GEM Premier ChemSTAT Predicate Device GEM Premier ChemSTAT K183549, K183546,K183555 Regulatory Information GEM Premier ChemSTAT… | 2019 |
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?
- The line of descent spans 43 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 13 of the 37 ancestors have a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen…
Read the full statement (414 words)
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status, electrolyte and metabolite balance.
Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
• Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
• Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
• Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
• Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223090: GEM Premier ChemSTAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223090
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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