510(k) · Cleared
ClearedALP IFCC Gen.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations (Rdo) · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on May 10, 2017 as substantially equivalent to K033185 (Roche Diagnostics Corp., 2003) after a 29-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- May 10, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895880 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 2 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK033185 Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003
- This deviceK171080 ALP IFCC Gen.2Roche Diagnostics Operations (Rdo) · 2017
- Descendant · cites it directly · 0 of its ownK191245 Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019
Most influential descendants
Showing 1 of 1 · See all- K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −2 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K033185 | Cobas Integra Alp Ifcc Gen.2 | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017 | — |
| +1 | K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Horiba Abx Sas | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K033185 | Cobas Integra Alp Ifcc Gen.2Summary page 5…cation of the predicate device. The Predicate Devices device name, ALP IFCC Gen.2, is unchanged from how it was cleared in 510(k) K033185. For the ALP IFCC Gen.2, the establishment registration number for Roch… | 2003 |
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 |
|---|---|---|---|
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | 2019 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K191245 (Horiba Abx Sas, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033185.
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. 2017, 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?
ALP IFCC Gen.2 is an in vitro test intended for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma on COBAS INTEGRA systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171080: ALP IFCC Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171080
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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