510(k) · Cleared
ClearedUB Analyzer UA-2, Reagent Kit and Bilirubin Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrows Co., Ltd. · CIG Diazo Colorimetry, Bilirubin
Cleared on Sep 14, 1998 as substantially equivalent to K871115 (Labo Science-USA, Inc., 1989) after a 445-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 14, 1998
- Review
- 445 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871115 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK871115 UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con.Labo Science-USA, Inc. · 1989
- This deviceK972382 UB Analyzer UA-2, Reagent Kit and Bilirubin ControlArrows Co., Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871115 | UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con. | Labo Science-USA, Inc. | 1989 | — |
| 0 (this device) | K972382 | UB Analyzer UA-2, Reagent Kit and Bilirubin Control | Arrows Co., Ltd. | 1998 | — |
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 |
|---|---|---|---|
| * | K871115 | UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con.Summary page 2…B analyzer UA-2 is similar in design and function to UB ANALYZER , MODEL UA-1/ REAGENT KIT / BILIRUBIN CON, which was approved with Premarket notification 510(K) number K871115 by FDA and marketed in USA by LABO SCIENCE-USA INC. We had been the original manufacturer of UB ANALYZER , MODEL UA-1/REAGENT KIT… | 1989 |
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.
What does this lineage say?
- Its one ancestor has no 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?
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and
unbound bilirubin concentration in neonatal serum using exclusive reagent kit, “UB TEST.”
The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to
provide the physician with additional information in the clinical assessment of jaundiced
neonates and the possible risk of bilirubin encephalopathy.
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/K972382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972382: UB Analyzer UA-2, Reagent Kit and Bilirubin Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972382
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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