510(k) Report

510(k) · Cleared

Cleared

Cobas Ready Calcium Reagent

K896224510(k) TraditionalCleared Aug 17, 1990291-day reviewClass II21 CFR 862.1145

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. · CIC Cresolphthalein Complexone, Calcium

Cleared on Aug 17, 1990 after a 291-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Aug 17, 1990
Review
291 days
Class
Class II
Product code
CIC
Recalls
None
Predicates
0

13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2007: 3 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2008: 1 descendant cleared2021: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK896224 Cobas Ready Calcium ReagentRoche Diagnostic Systems, Inc. · 1990
  2. Descendant · cites it directly · 11 of its ownK070249 Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase…Horiba Abx · 2007 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK070146 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007
  4. 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
  5. Descendant · 3 generations on · 2 of its ownK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008 · Recalled
  6. 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 13 descendants. See all descendants

Descendants cleared per year

2007: 32008: 12011: 32012: 12013: 12015: 12019: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 2007 · cites it directly11descendants
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007 · 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
  • K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 2008 · 3 generations on2descendants
  • 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
0 (this device)K896224Cobas Ready Calcium ReagentRoche Diagnostic Systems, Inc.1990—
+1K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine…Horiba Abx20071
+2K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx2007—
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…Horiba Abx Sas2013—
+3K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx20081
+2K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx…Horiba Abx Sas20123

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200810
201130
201210
201310
201510
201920
202110
FIG. 1 — Lineage of K896224, 1990–2021Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CIC? 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
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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? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx200711
K103615Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…Alfa Wassermann Diagnostic Technologies, Inc.20110

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, K070249 (Horiba Abx, 2007) has gone furthest, with 11 descendants of its own.

How does its category compare?

All CIC devices

CIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIC

1in 2013

2007: 12009: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIC

Too few CIC 510(k)s in any year since 2007 to give a median.

Recalls per year · CIC

1in 2016

2009: 32010: 22016: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIC

10in 2025

2009: 52010: 832011: 292012: 102013: 42014: 12016: 302017: 62018: 422021: 12023: 42024: 82025: 10
2007high 83 (2010) · low 0 (2007)2025

MAUDE reports naming product code CIC, 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
20071—00
20080—00
20091—35
20100—283
20110—029
20120—010
20131—04
20140—01
20150—00
20160—130
20170—06
20180—042
20190—00
20200—00
20210—01
20220—00
20230—04
20240—08
20250—010
20260—0—

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 CIC

The CIC category page

  • K130870Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)Hitachi Chemical Diagnostics, Inc. · 2013
  • K083339Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc. · 2009
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 20071 recall
  • K053401Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsArkray, Inc. · 20061 Class I recall
  • K050077Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen TestsArkray, Inc. · 2005

https://510kreport.com/device/K896224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896224: Cobas Ready Calcium Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896224

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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