510(k) · Cleared
ClearedGEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
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 Dec 14, 2016 as substantially equivalent to K133407 (Instrumentation Laboratory CO, 2014) and 1 other predicate after a 306-day review. Its family tree reaches back 9 generations to 1980. 2 later devices descend from it.
- Decided
- Dec 14, 2016
- Review
- 306 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K801848 (1980). 36 ancestors in all, the oldest K790608 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 5 generations between
- 3 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 2 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 1 generation backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- This deviceK160402 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total…Instrumentation Laboratory CO · 2016
- Descendant · cites it directly · 1 of its ownK203790 GEM Premier 5000Instrumentation Laboratory CO · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK223608 GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · Recalled
Show all 9 generations
- Root · 9 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 8 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 7 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 6 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 5 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 4 generations backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- 3 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 2 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 1 generation backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- This deviceK160402 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total…Instrumentation Laboratory CO · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −8 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −7 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −6 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −5 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −4 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| −3 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| −2 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| −1 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| 0 (this device) | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | 2016 | — |
| +1 | K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021 | 25 |
| +2 | K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K133407 | Gem Premier 4000Summary page 4…Trade Name (Measured Parameters: Glucose, Lactate, Total Bilirubin) GEM Premier 4000 K133407 Glucose and Lactate Predicate Devices ABL 837 K142898… | 2014 |
| * | K142898 | ABL800 FLEX with AQURE connectivitySummary page 4…GEM Premier 4000 K133407 Glucose and Lactate Predicate Devices ABL 837 K142898 Total Bilirubin Regulatory Information… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203790 | GEM Premier 5000 | 2021 | 1 |
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 36 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 16 of the 36 ancestors have a recall of any class.
- Of its descendants, K203790 (Instrumentation Laboratory CO, 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K133407.
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 GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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 glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient’s metabolite balance.…
Read the full statement (146 words)
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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 glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient’s metabolite balance.
Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and 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;
• in the diagnosis of hyperlactatemia.
Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160402: GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160402
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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