510(k) Report

510(k) · Cleared

Cleared

Ciba Corning Acs:180 Automated Chemiluminescence

K902336510(k) TraditionalCleared Jun 18, 199025-day reviewClass I21 CFR 862.2160

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. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Jun 18, 1990 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.

Decided
Jun 18, 1990
Review
25 days
Class
Class I
Product code
JJE
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2009: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2016: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2007: 1 descendant cleared2012: 3 descendants cleared2010: 3 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
  2. Descendant · cites it directly · 21 of its ownK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 18 of its ownK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
  4. Descendant · 3 generations on · 17 of its ownK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
  5. Descendant · 4 generations on · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1997: 22003: 12004: 12007: 12009: 22010: 32012: 32014: 12015: 12016: 12017: 32022: 12023: 22024: 1
1997high 3 (2010) · low 0 (1998)2026

Most influential descendants

Showing 5 of 23 · See all
  • K971418Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerChiron Diagnostics Corp. · 1997 · cites it directly21descendants
  • K032525Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003 · 2 generations on18descendants
  • K041133Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2004 · 3 generations on17descendants
  • K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · 4 generations on4descendants
  • K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902336Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp.1990—
+1K971418Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerChiron Diagnostics Corp.19974
+2K032525Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC2003—
+3K041133Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC20048
+4K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc.201522
+4K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc.20093

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200310
200410
200710
200920
201030
201230
201410
201510
201610
201730
202210
202320
202410
FIG. 1 — Lineage of K902336, 1990–2024Source: 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.

Planning a device in JJE? 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? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K971418Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerChiron Diagnostics Corp.199721
K972024Coda Automated Eia AnalyzerBio-Rad19970

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, K971418 (Chiron Diagnostics Corp., 1997) has gone furthest, with 21 descendants of its own.

How does its category compare?

All JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

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

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

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 JJE

The JJE category page

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  • K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, CarCarolina Liquid Chemistries Corp. · 2014
  • K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014
  • K131554RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) ReagentRandox Laboratories, Ltd. · 20143 recalls
  • K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 20136 recalls

https://510kreport.com/device/K902336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902336: Ciba Corning Acs:180 Automated Chemiluminescence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902336

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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