510(k) · Cleared
Clearedi-STAT CG8+ cartridge with the i-STAT 1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · JFP Electrode, Ion Specific, Calcium
Cleared on Oct 27, 2023 as substantially equivalent to K191360 (Abbott Point of Care, Inc., 2020) after a 266-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 27, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- JFP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001387 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- 2 generations backK061597 Epoc Blood Analysis SystemEpocal, Inc. · 2006 · Recalled
- 1 generation backK191360 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- This deviceK230300 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| −2 | K061597 | Epoc Blood Analysis System | Epocal, Inc. | 2006 | 2 |
| −1 | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| 0 (this device) | K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
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 JFP? 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 JFP device
- #1 K191360 i-STAT CHEM8+ cartridge with the i-STAT 1 Systemscore 5.2 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 4…Measuring III. PREDICATE DEVICE Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System 510(k) Number K191360 510(k) Summary Page 1 of 12 Product… | 2020 |
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 23 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K191360.
How does its category compare?
All JFP devicesJFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JFP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JFP
Too few JFP 510(k)s in any year since 2007 to give a median.
Recalls per year · JFP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFP
40in 2025
MAUDE reports naming product code JFP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings. Ionized calcium measurements are used in the…
Read the full statement (141 words)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone diseases, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230300: i-STAT CG8+ cartridge with the i-STAT 1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230300
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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