510(k) · Cleared
ClearedAxis %CDT Turbidimetric Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis · NAO Test, Carbohydrate Deficient Transferrin
Cleared on Dec 21, 1999 after a 148-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Dec 21, 1999
- Review
- 148 days
- Class
- Class I
- Product code
- NAO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK992502 Axis %CDT Turbidimetric ImmunoassayAxis · 1999
- Descendant · cites it directly · 1 of its ownK060677 N Latex CDTDade Behring, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK110169 Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992502 | Axis %CDT Turbidimetric Immunoassay | Axis | 1999 | — |
| +1 | K060677 | N Latex CDT | Dade Behring, Inc. | 2006 | 2 |
| +2 | K110169 | Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H | Siemens Healthcare Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 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 NAO? 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 |
|---|---|---|---|
| * | — | gamma glutamyl transferase (GGT) Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060677 | N Latex CDT | 2006 | 1 |
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, K060677 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NAO devicesNAO Test, Carbohydrate Deficient Transferrin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAO
FDA has decided no NAO device since 2007.
Median 510(k) review, days · NAO
Too few NAO 510(k)s in any year since 2007 to give a median.
Recalls per year · NAO
No recall names NAO since 2007.
Adverse event reports per year · NAO
No MAUDE report names NAO since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Axis ® %CDT Turbidimetric Immunoassay (TIA) is intended for the quantitative measurement of carbohydrate deficient transferrin (CDT) in human serum, as a tool to identify possible chronic heavy alcohol consumption. The Axis ® %CDT Turbidimetric Immunoassay is designed for the quantitative determination of carbohydrate deficient transferrin (CDT) in human serum. Serum transferrin is a glycoprotein with a molecular weight of about 80kD, which comprises…
Read the full statement (116 words)
The Axis ® %CDT Turbidimetric Immunoassay (TIA) is intended for the quantitative measurement of carbohydrate deficient transferrin (CDT) in human serum, as a tool to identify possible chronic heavy alcohol consumption.
The Axis ® %CDT Turbidimetric Immunoassay is designed for the quantitative determination of carbohydrate deficient transferrin (CDT) in human serum.
Serum transferrin is a glycoprotein with a molecular weight of about 80kD, which comprises a single polypeptide chain with two N-linked polysaccharide chains. These polysaccharide chains are branched with terminal sialic acid residues. Transferrin is an iron-transporting protein. Human transferrin occurs in isoforms with different levels of sialylation. There appear to be at least six such isoforms; penta-, tetra-, tri-, di-, mono- and asialo transferrin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992502: Axis %CDT Turbidimetric Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992502
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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