510(k) · Cleared
ClearedPancreatic a-Amylase Eps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CIL Cresol Red Colorimetry, Carbon-Dioxide
Cleared on Dec 19, 1989 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Dec 19, 1989
- Review
- 75 days
- Class
- Class II
- Product code
- CIL
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 2 citing it directly.
- This deviceK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- Descendant · cites it directly · 20 of its ownK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- Descendant · 2 generations on · 12 of its ownK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- Descendant · 3 generations on · 7 of its ownK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- Descendant · 4 generations on · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · 2 generations on · 3 of its ownK033185 Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K981897Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas…Roche Diagnostic Systems, Inc. · 1998 · cites it directly20descendants
- K003400CRP HS Test SystemRoche Diagnostics Corp. · 2001 · 2 generations on12descendants
- K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. · 2004 · 3 generations on7descendants
- K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · 4 generations on3descendants
- K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| +1 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| +2 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| +3 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| +4 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +2 | K033185 | Cobas Integra Alp Ifcc Gen.2 | Roche Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K981897 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 20 descendants of its own.
How does its category compare?
All CIL devicesCIL Cresol Red Colorimetry, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIL
FDA has decided no CIL device since 2007.
Median 510(k) review, days · CIL
Too few CIL 510(k)s in any year since 2007 to give a median.
Recalls per year · CIL
No recall names CIL since 2007.
Adverse event reports per year · CIL
No MAUDE report names CIL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K895880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895880: Pancreatic a-Amylase Eps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895880
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026