510(k) · Cleared
ClearedAlanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Cleared on Dec 5, 1997 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 5, 1997
- Review
- 45 days
- Class
- Class I
- Product code
- CKA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974003 Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30Diagnostic Chemicals, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK120945 Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi…Hitachi Chemical Diagnostics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…Hitachi Chemical Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974003 | Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30 | Diagnostic Chemicals, Ltd. | 1997 | — |
| +1 | K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical… | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test… | 2013 | 0 |
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?
- Of its descendants, K120945 (Hitachi Chemical Diagnostics, Inc., 2013) has gone furthest, with 0 descendants of its own.
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 the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use.
Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.'
1. Burtis, C.A., Ashwood, E.R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto, p 790-791 (1994).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974003: Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974003
Report an extraction error
Are you the manufacturer?
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