510(k) · Cleared
ClearedWiener Lab. Bilirrubina Total AA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratories Saic · CIG Diazo Colorimetry, Bilirubin
Cleared on Nov 1, 2002 after a 56-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 1, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | DMA Total Bilirubin Plus test system (Cat. No 1245) Named without a submission 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The “Wiener lab. Bilirrubina Total AA” test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022962: Wiener Lab. Bilirrubina Total AA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022962
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