510(k) Report

510(k) · Cleared

Cleared

(Modified Version) Integra Ion Selective Electrode (Ise) Module

K963627510(k) TraditionalCleared Oct 24, 199643-day reviewClass II21 CFR 862.1665

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. · JGS Electrode, Ion Specific, Sodium

Cleared on Oct 24, 1996 as substantially equivalent to K912648 (Boehringer Mannheim Corp., 1991) and 3 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1991. 20 later devices descend from it.

Decided
Oct 24, 1996
Review
43 days
Class
Class II
Product code
JGS
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K912649 (1991). 4 ancestors in all. 20 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1991: 2 other ancestors2006: 3 descendants cleared2013: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2011: 5 descendants cleared2007: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant clearedReference device: K951595 · Roche Cobas Integra Analyzer, Reagent Cassettes · Roche Diagnostic Systems, Inc. · 1995 · recalledK912649 · ISE/K+ · Boehringer Mannheim Corp. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 6 descendants K912649 · ISE/K+ · Boehringer Mannheim Corp. · 19910
  1. Root · 1 generation backK912649 ISE/K+Boehringer Mannheim Corp. · 1991
  2. This deviceK963627 (Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc. · 1996
  3. Descendant · cites it directly · 15 of its ownK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
  6. Descendant · cites it directly · 1 of its ownK123726 Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013
  7. Descendant · 2 generations on · 1 of its ownK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32007: 22008: 12010: 12011: 52012: 12013: 22014: 12015: 12019: 12021: 1
2005high 5 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · See all
  • K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · cites it directly15descendants
  • K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · 2 generations on3descendants
  • K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 2 generations on2descendants
  • K123726Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013 · cites it directly1descendant
  • K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas · 2012 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912649ISE/K+Boehringer Mannheim Corp.1991—
0 (this device)K963627(Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc.1996—
+1K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx20056
+2K060854Abx Pentra 400: LipoproteinsHoriba Abx20062
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…Horiba Abx Sas2013—
+1K123726Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics2013—
+2K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx…Horiba Abx Sas20123

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200720
200810
201010
201150
201210
201320
201410
201510
201910
202110
FIG. 1 — Lineage of K963627, 1991–2021Source: 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 JGS? 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 JGS device

  1. #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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? (4)

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
*K912648ISE/NA+
Summary page 3
…redicate Devices Product Name Predicate Product K date of Name number substantial equivalenc Roche COBAS INTEGRA ISE Module Tests: Direct Sodium BM / Hitachi 911 Sodium K912648 07/17/1 (Indirect) Direct Potassium BM / Hitachi 911 K912649 07/15/91 Potassium (Indirect) Direct Chloride BM / Hitachi 911 Chlor…
Boehringer Mannheim Corp.1991—
*K912649ISE/K+
Summary page 3
…me number substantial equivalenc Roche COBAS INTEGRA ISE Module Tests: Direct Sodium BM / Hitachi 911 Sodium K912648 07/17/1 (Indirect) Direct Potassium BM / Hitachi 911 K912649 07/15/91 Potassium (Indirect) Direct Chloride BM / Hitachi 911 Chloride K912647 07/17/91 (Indirect) Direct Lithium Kodak Ectachem…
Boehringer Mannheim Corp.1991—
*K912647ISE/CI-
Summary page 3
…dium BM / Hitachi 911 Sodium K912648 07/17/1 (Indirect) Direct Potassium BM / Hitachi 911 K912649 07/15/91 Potassium (Indirect) Direct Chloride BM / Hitachi 911 Chloride K912647 07/17/91 (Indirect) Direct Lithium Kodak Ectachem Lithium K924488 01/26/93 Indirect Sodium BM / Hitachi 911 Sodium K912648 07/17/…
Boehringer Mannheim Corp.1991—
*K924488Kodak Ektachem Clinical Chemistry Slides (LI)
Summary page 3
…assium BM / Hitachi 911 K912649 07/15/91 Potassium (Indirect) Direct Chloride BM / Hitachi 911 Chloride K912647 07/17/91 (Indirect) Direct Lithium Kodak Ectachem Lithium K924488 01/26/93 Indirect Sodium BM / Hitachi 911 Sodium K912648 07/17/91 (Indirect) Indirect Potassium BM / Hitachi 911 K912649 07/15/91…
Eastman Kodak Company19932
†K951595Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc.19957

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx200515
K123726Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics20131
K063684Cobas LithiumRoche Diagnostics Corp.20080
K060108Cobas Integra Chloride Elctrode Gen.2Roche Diagnostics Corp.20060

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 4 ancestors has a recall of any class.
  • Of its descendants, K052007 (Horiba Abx, 2005) has gone furthest, with 15 descendants of its own.

How does its category compare?

All JGS devices

JGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGS

3in 2023

2008: 22009: 22010: 12011: 32012: 12013: 22014: 12015: 12016: 42017: 12018: 32019: 32020: 22022: 12023: 32026 (partial year): 1
2007high 4 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGS

347in 2023

2011: 191 days median2016: 198 days median2018: 180 days median2019: 58 days median2023: 347 days median
2007high 347 (2023) · low 58 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JGS

4in 2023

2007: 72008: 12010: 12011: 12012: 22013: 52015: 12019: 52020: 12021: 12023: 4
2007high 7 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JGS

64in 2025

2007: 332008: 32009: 572010: 3612011: 9122012: 4122013: 5102014: 2512015: 1582016: 842017: 2922018: 1582019: 1052020: 892021: 912022: 602023: 982024: 962025: 64
2007high 912 (2011) · low 3 (2008)2025

MAUDE reports naming product code JGS, 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—733
20082—13
20092—057
20101—1361
201131911912
20121—2412
20132—5510
20141—0251
20151—1158
20164198084
20171—0292
201831800158
20193585105
20202—189
20210—191
20221—060
20233347498
20240—096
20250—064
20261—0—

What is it indicated for?

The COBAS INTEGRA ISE module applications are intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations using ion-selective electrodes:

the direct application is intended for undiluted serum and plasma

the indirect application is intended for diluted serum and plasma (does not include lithium)

the urine application is intended for diluted urine (does not include lithium)

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

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 JGS

The JGS category page

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  • K213486GLP systems TrackAbbott Laboratories · 2022

https://510kreport.com/device/K963627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963627

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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