510(k) Report

510(k) · Cleared

Cleared

Ciba Corning Acs LH Immunoassay

K910198510(k) TraditionalCleared Feb 4, 199119-day reviewClass I21 CFR 862.1485

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. · CEP Radioimmunoassay, Luteinizing Hormone

Cleared on Feb 4, 1991 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 4, 1991
Review
19 days
Class
Class I
Product code
CEP
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK910198 Ciba Corning Acs LH ImmunoassayCiba Corning Diagnostics Corp. · 1991
  2. Descendant · cites it directly · 1 of its ownK962041 Acs LH2 ImmunoassayCiba Corning Diagnostics Corp. · 1996
  3. Descendant · 2 generations on · 0 of its ownK101460 Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics · 2010 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K962041Acs LH2 ImmunoassayCiba Corning Diagnostics Corp. · 1996 · cites it directly1descendant
  • K101460Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910198Ciba Corning Acs LH ImmunoassayCiba Corning Diagnostics Corp.1991—
+1K962041Acs LH2 ImmunoassayCiba Corning Diagnostics Corp.1996—
+2K101460Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201010
FIG. 1 — Lineage of K910198, 1991–2010Source: 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 CEP? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K962041Acs LH2 ImmunoassayCiba Corning Diagnostics Corp.19961

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, K962041 (Ciba Corning Diagnostics Corp., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CEP devices

CEP Radioimmunoassay, Luteinizing Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEP

FDA has decided no CEP device since 2007.

Median 510(k) review, days · CEP

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

Recalls per year · CEP

1in 2022

2012: 12021: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · CEP

1in 2023

2007: 52008: 22011: 32014: 172015: 12023: 1
2007high 17 (2014) · low 0 (2009)2025

MAUDE reports naming product code CEP, 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—05
20080—02
20090—00
20100—00
20110—03
20120—10
20130—00
20140—017
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—10
20220—10
20230—01
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 CEP

The CEP category page

  • K013582Maybe?Mom Mini Ovulation MicroscopeMaybe?Mom · 2003
  • K022829Instant-View LH Ovulation Predicting TestAlfa Scientific Designs, Inc. · 2002
  • K021409AT Home Ovulation Test, Model 9032Phamatech, Inc. · 2002
  • K013874Clearplane Easy Ovulation TestUnipath, Ltd. · 2002
  • K013323Tci-31 Lifelong Ovulation TesterTci New York · 2001

https://510kreport.com/device/K910198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910198: Ciba Corning Acs LH Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910198

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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