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 · JFY Enzymatic Method, Creatinine
Cleared on Feb 16, 2019 as substantially equivalent to K024098 (Roche Diagnostics Corp., 2002) and 2 other predicates after a 58-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- Feb 16, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K842280 (1984). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 3 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 2 generations backK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- This deviceK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · cites it directly · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
Most influential descendants
Showing 1 of 1 · See all- K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −3 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −2 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +1 | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 JFY? 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 JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 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 |
|---|---|---|---|
| * | K024098 | Cobas Integra Creatinine Plus Ver.2 AssaySummary page 4…ry 11, 2019 GEM Premier ChemSTAT Device Trade Name Cobas Integra Creatinine Plus Ver. 2 K024098 Predicate Devices Cobas Integra Urea/BUN K954000 Cobas… | 2002 |
| * | K954000 | Roche Reagent for BunSummary page 4…Cobas Integra Creatinine Plus Ver. 2 K024098 Predicate Devices Cobas Integra Urea/BUN K954000 Cobas Integra Bicarbonate Liquid K031879… | 1995 |
| * | K031879 | Cobas Integra Carbon Dioxide AssaySummary page 4…dicate Devices Cobas Integra Urea/BUN K954000 Cobas Integra Bicarbonate Liquid K031879 Regulatory Information Regulation… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223090 | GEM Premier ChemSTAT | 2023 | 0 |
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 35 years and passes through 4 companies; a new generation was cleared every 13.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K223090 (Instrumentation Laboratory CO, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K024098.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) from arterial and venous heparinized whole blood. These parameters, along with…
Read the full statement (152 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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status and metabolite balance.
• 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183555: GEM Premier ChemSTAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183555
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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