510(k) · Cleared
Recalled · 2007Roche Cobas Integra Reagent Cassettes & Ancillary Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · JFJ Catalytic Methods, Amylase
Cleared on Aug 12, 1997 as substantially equivalent to K913124 (Roche Diagnostic Systems, Inc., 1991) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1984. 17 later devices descend from it. It has been recalled once.
- Decided
- Aug 12, 1997
- Review
- 57 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K842280 (1984). 3 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK842280 TDX DigitoxinAbbott Laboratories · 1984
- This deviceK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- Descendant · 2 generations on · 8 of its ownK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- Descendant · 3 generations on · 2 of its ownK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
- Descendant · 3 generations on · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · 3 generations on · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc. · 1998 · cites it directly9descendants
- K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003 · 2 generations on8descendants
- K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003 · 3 generations on2descendants
- K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · 3 generations on1descendant
- K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| 0 (this device) | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | — |
| +1 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| +2 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| +3 | K032377 | Roche Diagnostics Hitachi Bicarbonate Liquid | Roche Diagnostics Corp. | 2003 | — |
| +3 | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +3 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 JFJ? 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 JFJ device
- #1 K210633 Amylase2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K913124 | Roche Reagent for AmmoniaSummary page 3…s, Inc. claims equivalence. - Table 2 Product Name Predicate Product Name K number |Date of substantial equivalence COBAS INTEGRA... Ammonia Roche Reagent for Ammonia K913124 8/12/91 aAmylase EPS (Liquid) COBAS INTEGRA cAmylase (Granulate, K951595 9/8/95 CL-PNP-G, method) Cholesterol (Liquid) COBAS IN… | 1991 |
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 3…K number |Date of substantial equivalence COBAS INTEGRA... Ammonia Roche Reagent for Ammonia K913124 8/12/91 aAmylase EPS (Liquid) COBAS INTEGRA cAmylase (Granulate, K951595 9/8/95 CL-PNP-G, method) Cholesterol (Liquid) COBAS INTEGRA Cholesterol (Granulate) | K951595 9/8/95 HDL - Cholesterol (Liquid)… | 1995 |
| * | K842280 | TDX DigitoxinSummary page 3…DL - Cholesterol K951595 9/8/95 (Granulate) Creatinine (Enzymatic) COBAS INTEGRA Creatinine (Kinetic K951595 9/8/95 Jaffe) Digitoxin Abbott Diagnostics, TDX / TDX Flex K842280 8/16/84 Digitoxin Reagent Gamma-Glutamyltransferase (GGT) COBAS INTEGRA Lipase (Granulate) K951595 9/8/95 Glucose HK COBAS INTE… | 1984 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | 1998 | 9 |
| K061048 | Cobas Integra Glucose HK Gen. 3 Test System | 2006 | 1 |
| K031856 | Preciset TDM I and Preciset TDM II Calibrators | 2003 | 1 |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | 2014 | 0 |
| K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and… | 2011 | 0 |
| K062239 | Glucose HK New Formulation Test System | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2007 | Not classified | Z-0688-2008 | Process design | False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K980996 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JFJ
Too few JFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JFJ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFJ
1in 2025
MAUDE reports naming product code JFJ, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
COBAS INTEGRA Ammonia (NH3): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045). COBAS INTEGRA oAmylase EPS (AMYLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999).…
Read the full statement (466 words)
COBAS INTEGRA Ammonia (NH3):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045).
COBAS INTEGRA oAmylase EPS (AMYLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999).
COBAS INTEGRA Cholesterol (CHOLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL - cholesterol concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA HDL - Cholesterol Application (HDLL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA Creatinine Enzymatic (CREAE):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114).
COBAS INTEGRA Digitoxin (DIGIT):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259).
COBAS INTEGRA Gamma - Glutamyltransferase (GGTL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599).
COBAS INTEGRA Glucose HK Liquid (GLUCL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993).
COBAS INTEGRA Lipase (LIPL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200).
COBAS INTEGRA Lysergic acid diethylamide (LSD)
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, O-001)
COBAS INTEGRA Urea/BUN (UREAL):
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004).
Roche TDM OnLine Digitoxin Calibrators:
are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma.
Roche TDM OnLine Digitoxin Controls:
are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972250
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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