510(k) · Cleared
ClearedCareside Alt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Cleared on Jun 4, 2002 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 111-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 4, 2002
- Review
- 111 days
- Class
- Class I
- Product code
- CKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK020487 Careside AltCareside, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K020487 | Careside Alt | Careside, Inc. | 2002 | — |
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 CKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 2…LT Premarket Notification Page 11 April 30,2002 Predicate Device 5 10K number: K9 12844lA Product Code: 75cKA IV. Device Description CARESIDE ALT cartridges are used wit… | 1991 |
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?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All CKA devicesCKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CKA
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CKA
Too few CKA 510(k)s in any year since 2007 to give a median.
Recalls per year · CKA
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKA
8in 2025
MAUDE reports naming product code CKA, 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 | — | 8 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020487: Careside Alt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020487
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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