510(k) Report

510(k) · Cleared

Cleared

Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae

K981897510(k) TraditionalCleared Aug 26, 199886-day reviewClass II21 CFR 862.1050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostic Systems, Inc. · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Cleared on Aug 26, 1998 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1989. 20 later devices descend from it.

Decided
Aug 26, 1998
Review
86 days
Class
Class II
Product code
CJE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K895880 (1989). 2 ancestors in all. 20 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2003: 2 descendants cleared2001: 1 descendant cleared2008: 1 descendant cleared2004: 1 descendant cleared2017: 3 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2018: 2 descendants cleared2009: 1 descendant cleared2006: 1 descendant cleared2019: 2 descendants cleared2026: 1 descendant cleared2020: 1 descendant clearedK895880 · Pancreatic a-Amylase Eps · Boehringer Mannheim Corp. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant K895880 · Pancreatic a-Amylase Eps · Boehringer Mannheim Corp. · 19890+5
  1. Root · 1 generation backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
  2. This deviceK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
  3. Descendant · cites it directly · 12 of its ownK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
  4. Descendant · 2 generations on · 7 of its ownK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
  6. Descendant · cites it directly · 3 of its ownK033185 Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003
  7. Descendant · 2 generations on · 3 of its ownK032336 Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22004: 12006: 12008: 12009: 12011: 22012: 22017: 32018: 22019: 22020: 12026: 1
2001high 3 (2017) · low 0 (2002)2026

Most influential descendants

Showing 5 of 20 · See all
  • K003400CRP HS Test SystemRoche Diagnostics Corp. · 2001 · cites it directly12descendants
  • K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. · 2004 · 2 generations on7descendants
  • K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · 3 generations on3descendants
  • K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp. · 2003 · cites it directly3descendants
  • K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895880Pancreatic a-Amylase EpsBoehringer Mannheim Corp.1989—
0 (this device)K981897Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche…Roche Diagnostic Systems, Inc.1998—
+1K003400CRP HS Test SystemRoche Diagnostics Corp.2001—
+2K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High…Roche Diagnostics Corp.20041
+3K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories2011—
+1K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp.2003—
+2K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200410
200610
200810
200910
201120
201220
201730
201820
201920
202010
202610
FIG. 1 — Lineage of K981897, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251074 Tru Liver Health Test Panelscore 10.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K951595Roche Cobas Integra Analyzer, Reagent Cassettes
Summary page 2
…ystems, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number COBAS INTEGRA COBAS INTEGRA Alkaline 9/8/95 K951595 Alkaline Phosphatase IFCC liquid |Phosphatase IFCC (ALP) (ALPL2) (ALPL6) COBAS INTEGRA a.Amylase EPS |Boehringer Mannheim/ Hitach…
Roche Diagnostic Systems, Inc.19957
*K895880Pancreatic a-Amylase Eps
Summary page 2
…TEGRA Alkaline 9/8/95 K951595 Alkaline Phosphatase IFCC liquid |Phosphatase IFCC (ALP) (ALPL2) (ALPL6) COBAS INTEGRA a.Amylase EPS |Boehringer Mannheim/ Hitachi 12/19/89 K895880 Pancreatic Pancreatic (AMY-P/ AMYUP) a-Amylase liquid COBAS INTEGRA C-Reactive COBAS INTEGRA C-Reactive 9/8/95 K951595 Protein (L…
Boehringer Mannheim Corp.1989—

Also cleared against K951595: 31 other devices →

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K003400CRP HS Test SystemRoche Diagnostics Corp.200112
K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp.20033
K073277Roche-Creactive Protein (Latex)Roche Diagnostics Corp.20082

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K003400 (Roche Diagnostics Corp., 2001) has gone furthest, with 12 descendants of its own.
  • 31 other devices also cite its predicate K951595.

How does its category compare?

All CJE devices

CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CJE

1in 2025

2008: 12011: 22012: 12013: 22017: 22018: 12019: 12023: 12024: 12025: 1
2007high 2 (2011) · low 0 (2007)2026

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

2008: 82011: 12013: 1
2007high 8 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CJE

10in 2025

2010: 32011: 242019: 12020: 12021: 12022: 62023: 112024: 112025: 10
2007high 24 (2011) · low 0 (2007)2025

MAUDE reports naming product code CJE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—80
20090—00
20100—03
20112—124
20121—00
20132—10
20140—00
20150—00
20160—00
20172—00
20181—00
20191—01
20200—01
20210—01
20220—06
20231—011
20241—011
20251—010
20260—0—

What is it indicated for?

The cassette COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. The cassette COBAS INTEGRA a-Amylase EPS…

Read the full statement (147 words)

The cassette COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The cassette COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of pancreatic a-amylase in serum, plasma, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The cassette C-reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human C-reactive protein in serum and plasma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951595

31 other devices cite the same predicate.

  • K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL…Elitechgroup · 2016
  • K160570Creatine KinaseRoche Diagnostics Operations (Rdo) · 20161 recall
  • K081193Cobas Integra 400/800 Bilirubin TotalRoche Diagnostics · 2009
  • K071644Online Phenobarbital, Model 03016757190 & 03510620Roche Diagnostics Corp. · 2007
  • K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and…Roche Diagnostics Corp. · 2006
  • K060773Online TDM ProcainamideRoche Diagnostics Corp. · 2006

More from Roche Diagnostic Systems, Inc.

296 FDA decisions under this applicant name. See the company

  • K983698Modification to Abuscreen Online BarbituratesRoche Diagnostic Systems, Inc. · 1999
  • K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
  • K983704Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
  • K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc. · 1998
  • K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc. · 1998

Recent decisions in CJE

The CJE category page

  • K251074Tru Liver Health Test PanelTruvian Health · 2025
  • K240468Alkaline PhosphataseAbbott Laboratories Diagnostics Division · 2024
  • K223317Alkaline Phosphatase2Abbott Ireland Diagnostics Division · 2023
  • K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019
  • K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B. · 2018

https://510kreport.com/device/K981897 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981897

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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