510(k) · Cleared
Recalled · 2011Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CIG Diazo Colorimetry, Bilirubin
Cleared on Jun 18, 2010 as substantially equivalent to K991417 (Radiometer America, Inc., 1999) and 2 other predicates after a 207-day review. Its family tree reaches back 6 generations to 1980. 12 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 18, 2010
- Review
- 207 days
- Class
- Class II
- Product code
- CIG
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 6 generations to K801848 (1980). 21 ancestors in all, the oldest K790608 (1979). 12 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 5 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 4 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 3 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 2 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 1 generation backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- This deviceK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010
- Descendant · cites it directly · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 2 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 3 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
- Descendant · cites it directly · 2 of its ownK160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride…Instrumentation Laboratory CO · 2016
- Descendant · 3 generations on · 2 of its ownK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · cites it directly11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 2 generations on10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 3 generations on2descendants
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO · 2016 · cites it directly2descendants
- K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −5 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −4 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −3 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −2 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −1 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| 0 (this device) | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | — |
| +1 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +2 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +3 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
| +1 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized… | Instrumentation Laboratory CO | 2016 | — |
| +3 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin… | Instrumentation Laboratory CO | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 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 |
|---|---|---|---|
| * | K991417 | Abl 735 AnalyzerSummary page 1…Class 11 * Product Codes: CIG MQM JJY GLK Predicate Devices: K991417 ABL 735 Analyzer K061974 GEM Premier 4000 with iQM and CVP K860942 Q… | 1999 |
| * | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Summary page 1…s: CIG MQM JJY GLK Predicate Devices: K991417 ABL 735 Analyzer K061974 GEM Premier 4000 with iQM and CVP K860942 Quantimetrix Bilirubin Control Attachment A… | 2006 |
| * | K860942 | Quantimetrix Human Bilirubin Control I & II LiquidSummary page 1…JJY GLK Predicate Devices: K991417 ABL 735 Analyzer K061974 GEM Premier 4000 with iQM and CVP K860942 Quantimetrix Bilirubin Control Attachment A GEM Premier 4000 System 5 10(k)… | 1986 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2011 | Not classified | Z-2806-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| May 31, 2011 | Not classified | Z-2805-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| May 31, 2011 | Not classified | Z-2803-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| May 31, 2011 | Not classified | Z-2804-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| Feb 14, 2011 | Not classified | Z-2165-2011 | Device Design | Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 21 ancestors have a recall of any class.
- Of its descendants, K112995 (Instrumentation Laboratory CO, 2012) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K991417.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, PCO 2, P02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilimubin and CO-Oximetry (tHb, O2 Hb, COHb, MetHb, HHb) parameters. Total bilirubin…
Read the full statement (378 words)
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, PCO 2, P02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilimubin and CO-Oximetry (tHb, O2 Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples When analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemnolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP H-ematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
GEM System Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of pH, PCO2, PO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 analyzer.
GEM Hematocrit Evaluator is a three-level assayed quality control material for evaluating performance characteristics of hematocrit on the GEM Premier 4000 analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093623 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093623
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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