510(k) · Cleared
ClearedIqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product)
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 Sep 10, 2002 as substantially equivalent to K010520 (Instrumentation Laboratory CO, 2001) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1980. 17 later devices descend from it.
- Decided
- Sep 10, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801848 (1980). 8 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 2 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 1 generation backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- This deviceK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- Descendant · cites it directly · 16 of its ownK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- Descendant · 2 generations on · 14 of its ownK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- Descendant · 3 generations on · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · 3 generations on · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 4 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K052121Gem Premier 3000Instrumentation Laboratory CO · 2005 · cites it directly16descendants
- K061974Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Instrumentation Laboratory CO · 2006 · 2 generations on14descendants
- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · 3 generations on12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · 3 generations on11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −2 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −1 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| 0 (this device) | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| +1 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| +2 | 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 |
| +3 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +4 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 5 | 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 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 |
|---|---|---|---|
| * | K010520 | Gem Premier 3000- Addition of Glucose and Lactate as New ParametersSummary page 1…health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520. Intelligent Quality Management (iQMTM) is being introduced on the GEM@Premier 3000 as an active quality process control… | 2001 |
| * | K992834 | Gem Premier 3000Summary page 1…ContrIL@9 (FDA cleared as a blood gas/electrolyte/metabolite quality control with the introduction of glucose and lactate on the GEM@Premier 3000) K992834 GEM@critCheck (FDA cleared as a hematocrit quality control with the introduction of the GEM@Premier 300… | 1999 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052121 | Gem Premier 3000 | 2005 | 16 |
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 22 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K052121 (Instrumentation Laboratory CO, 2005) has gone furthest, with 16 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520. Intelligent Quality Management (iQM) is being introduced on the GEM Premier 3000 as an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error…
Read the full statement (248 words)
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520.
Intelligent Quality Management (iQM) is being introduced on the GEM Premier 3000 as 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.
As part of this program, GEM CVP (Calibration Validation Product) is intended for the external verification of the iQM cartridge calibration after initial warm-up to ensure its integrity. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes and metabolites; two levels for hematocrit) must meet 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.
To ensure that a total quality management system is adhered to, laboratories should follow local, state and federal regulatory guidelines. As with any analytical device or computer software, there is always the potential for software failure. However, IL conducts rigorous testing and extensive software validation prior to releasing a software revision. If the user encounters a rare software error code, it should be reported to your local IL Technical Support Representative.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022158: Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022158
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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