510(k) · Cleared
ClearedYumizen C1200 ALP, Yumizen C1200 Albumin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Aug 30, 2019 as substantially equivalent to K171080 (Roche Diagnostics Operations (Rdo), 2017) and 1 other predicate after a 113-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Aug 30, 2019
- Review
- 113 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895880 (1989). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 3 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK033185 Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003
- 1 generation backK171080 ALP IFCC Gen.2Roche Diagnostics Operations (Rdo) · 2017
- This deviceK191245 Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −3 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K033185 | Cobas Integra Alp Ifcc Gen.2 | Roche Diagnostics Corp. | 2003 | — |
| −1 | K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017 | — |
| 0 (this device) | K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Horiba Abx Sas | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1995 | 1 | 0 |
| 2007 | 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 CJE? 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 CJE device
- #1 K251074 Tru Liver Health Test Panelscore 10.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K171080 | ALP IFCC Gen.2Summary page 6…number Yumizen C1200 ALP IFCC Gen2 COBAS 8000/Roche Diagnostics K171080 ALP Yumizen C1200 ABX Pentra 400/Pentra C400 / Albumin A… | 2017 |
| * | K060434 | Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx…Summary page 6…ABX Pentra 400/Pentra C400 / Albumin ABX Pentra Albumin CP K060434 HORIBA ABX SAS The following tables show the similarities and differen… | 2007 |
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?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All CJE devicesCJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJE
Too few CJE 510(k)s in any year since 2007 to give a median.
Recalls per year · CJE
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJE
10in 2025
MAUDE reports naming product code CJE, 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 | — | 0 | 0 |
| 2008 | 1 | — | 8 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 2 | — | 1 | 24 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Yumizen C 1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in huntan serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving prinrarily the liver or kidneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191245 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191245
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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