510(k) Report

510(k) · Cleared

Cleared

Liquid Cardiac Marker 1,2,3 Assayed

K960246510(k) TraditionalCleared Apr 23, 199698-day reviewClass I21 CFR 862.1660

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

Ciba Corning Diagnostics Corp. · JJT Enzyme Controls (Assayed And Unassayed)

Cleared on Apr 23, 1996 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Apr 23, 1996
Review
98 days
Class
Class I
Product code
JJT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960246 Liquid Cardiac Marker 1,2,3 AssayedCiba Corning Diagnostics Corp. · 1996
  2. Descendant · cites it directly · 0 of its ownK030102 Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K030102Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960246Liquid Cardiac Marker 1,2,3 AssayedCiba Corning Diagnostics Corp.1996—
+1K030102Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K960246, 1996–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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  • 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030102Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC20030

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, K030102 (Bayer Healthcare, LLC, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJT devices

JJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJT

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJT

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

Recalls per year · JJT

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JJT

1in 2011

2007: 12009: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JJT, 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—01
20080—00
20091—01
20100—01
20110—01
20120—10
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Ciba Corning Diagnostics Corp.

125 FDA decisions under this applicant name. See the company

  • K962559Acs Cortisol ImmunoassayCiba Corning Diagnostics Corp. · 19962 recalls
  • K963251Ciba Corning Acs;180 DPD AssayCiba Corning Diagnostics Corp. · 1996
  • K961807Certain HCT Level a & Level B/CVM HCT Levels 1,2,3, & 4Ciba Corning Diagnostics Corp. · 1996
  • K961657Ciba Corning 400 SystemCiba Corning Diagnostics Corp. · 1996
  • K962021Ciba Corning 348 SystemCiba Corning Diagnostics Corp. · 1996

Recent decisions in JJT

The JJT category page

  • K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
  • K062751Modification to Quantimetrix Cardiasure Cardiac MarkerQuantimetrix Corp. · 2006
  • K030768Cliniqa Liquid QC Cardiac Marker Control Levels 1, 2 & 3, Tri-LevelCliniqa Corporation · 20031 recall
  • K030102Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3Bayer Healthcare, LLC · 2003
  • K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002

https://510kreport.com/device/K960246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960246: Liquid Cardiac Marker 1,2,3 Assayed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960246

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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