510(k) · Cleared
ClearedElittech Clinical Systems Alp Ifcc SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Dec 29, 2011 as substantially equivalent to K033185 (Roche Diagnostics Corp., 2003) after a 55-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 29, 2011
- Review
- 55 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. No later device cites it as a predicate yet.
- 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 deviceK113269 Elittech Clinical Systems Alp Ifcc SLElitechgroup · 2011
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) | K113269 | Elittech Clinical Systems Alp Ifcc SL | Elitechgroup | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 1…WJE- Nitrophenylphosphate, alkaline phosphatase or isoentymes Predicate device Roche Diagnostics ALP2S (Alkaline phosphatase acc. to IFCC Gen.2) (K<033185) Device description The device for this submission Isavailable as kit only. It consists of 2 re… | 2003 |
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 22 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2011, 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?
ELiTech Clinical Systems ALP IFCC SL is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma on ELiTech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Alkaline phosphatase or its isoienzymes measurements 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/K113269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113269: Elittech Clinical Systems Alp Ifcc SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113269
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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