510(k) Report

510(k) · Cleared

Cleared

Ciba Corning Acs Estradiol Immunoassay

K932715510(k) TraditionalCleared Dec 3, 1993182-day reviewClass I21 CFR 862.1260

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. · CHP Radioimmunoassay, Estradiol

Cleared on Dec 3, 1993 after a 182-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
Dec 3, 1993
Review
182 days
Class
Class I
Product code
CHP
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared1990200020102020
  1. This deviceK932715 Ciba Corning Acs Estradiol ImmunoassayCiba Corning Diagnostics Corp. · 1993
  2. Descendant · cites it directly · 0 of its ownK100293 Advia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc. · 2010 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K100293Advia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932715Ciba Corning Acs Estradiol ImmunoassayCiba Corning Diagnostics Corp.1993—
+1K100293Advia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K932715, 1993–2010Source: 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 CHP? 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 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
K100293Advia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc.20100

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, K100293 (Siemens Heatlhcare Diagnostics, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CHP devices

CHP Radioimmunoassay, Estradiol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHP

FDA has decided no CHP device since 2007.

Median 510(k) review, days · CHP

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

Recalls per year · CHP

7in 2022

2007: 12010: 12016: 12017: 12018: 12021: 12022: 7
2007high 7 (2022) · low 0 (2008)2026

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

Adverse event reports per year · CHP

84in 2025

2008: 12009: 92010: 122011: 102012: 152013: 42014: 122015: 182016: 292017: 392018: 382019: 362020: 1352021: 432022: 612023: 602024: 652025: 84
2007high 135 (2020) · low 0 (2007)2025

MAUDE reports naming product code CHP, 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—10
20080—01
20090—09
20100—112
20110—010
20120—015
20130—04
20140—012
20150—018
20160—129
20170—139
20180—138
20190—036
20200—0135
20210—143
20220—761
20230—060
20240—065
20250—084
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 CHP

The CHP category page

  • K041349Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumIbl GmbH · 2004
  • K97390117 B-Estradiol (Elisa)Kmi Diagnostics, Inc. · 1997
  • K973743Access Estradiol Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19972 recalls
  • K970386Acs Estadiol-6 IIChiron Diagnostics Corp. · 1997
  • K970643Vitros Immunodiagnostics Products Estradiol Reagent Pack (Gem. 1050)/Estradiol Calibrators (Gem.C050)Johnson & Johnson Clinical Diagnostics, Inc. · 19971 recall

https://510kreport.com/device/K932715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932715: Ciba Corning Acs Estradiol Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932715

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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