510(k) · Cleared
Recalled · Class II · 2020N Latex CDT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · NAO Test, Carbohydrate Deficient Transferrin
Cleared on Aug 25, 2006 as substantially equivalent to K992502 (Axis, 1999) after a 164-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 25, 2006
- Review
- 164 days
- Class
- Class I
- Product code
- NAO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992502 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K110169Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con HSiemens Healthcare Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992502 | Axis %CDT Turbidimetric Immunoassay | Axis | 1999 | — |
| 0 (this device) | K060677 | N Latex CDT | Dade Behring, Inc. | 2006 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K992502 | Axis %CDT Turbidimetric ImmunoassaySummary page 1…nical Chemistry (75) Product Code: NAO 3. Identification of the Legally Marketed Device: Axis-Shield %CDT Assay - K992502 4. Device Description: The CDT in the sample competes with CDT-coated polystyrene particles for the bond t… | 1999 |
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 |
|---|---|---|---|
| K110169 | Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2020 | Class II | Z-1790-2020 | Under Investigation by firm | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring |
| May 31, 2018 | Class II | Z-2931-2018 | Under Investigation by firm | Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K110169 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 0 descendants 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?
In vitro diagnostic for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BNTM IIand BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060677: N Latex CDT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060677
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