510(k) · Cleared
Recalled · Class II · 2015Advia Chemistry Acetaminophen Reagent, Model Ref 07989138
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LDP Colorimetry, Acetaminophen
Cleared on Aug 2, 2010 after a 189-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Aug 2, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 1
- Predicates
- 0
The FDA summary names no predicate by number.
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 LDP? 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 LDP device
- #1 K261364 Atellica CH Acetaminophen 2 (ACTM)score 11.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2015 | Class II | Z-2416-2015 | Unknown/Undetermined by firm | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LDP
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LDP
Too few LDP 510(k)s in any year since 2007 to give a median.
Recalls per year · LDP
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDP
3in 2025
MAUDE reports naming product code LDP, 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 | — | 1 | 6 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 2 | 5 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Such measurements are used in the detection of acetaminophen overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100200: Advia Chemistry Acetaminophen Reagent, Model Ref 07989138.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100200
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)
- Page last updated Nov 3, 2026