510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Ciba Corning Acs Progesterone Immunoassay

K932955510(k) TraditionalCleared Aug 2, 199346-day reviewClass I21 CFR 862.1620Recalls 11

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. · JLS Radioimmunoassay, Progesterone

Cleared on Aug 2, 1993 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 11 times.

Decided
Aug 2, 1993
Review
46 days
Class
Class I
Product code
JLS
Recalls
11
Predicates
0

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

FIG. 1 — Lineage of K932955Source: FDA 510(k) database · 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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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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 4, 2017Class IIZ-1421-2017Nonconforming Material/ComponentDHEA-S causes falsely elevated progesterone results.
Jan 4, 2017Class IIZ-1420-2017Nonconforming Material/ComponentDHEA-S causes falsely elevated progesterone results.
Jan 4, 2017Class IIZ-1418-2017Nonconforming Material/ComponentDHEA-S causes falsely elevated progesterone results.
Jan 4, 2017Class IIZ-1419-2017Nonconforming Material/ComponentDHEA-S causes falsely elevated progesterone results.
Feb 4, 2016Class IIZ-1079-2016Under Investigation by firmADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Feb 4, 2016Class IIZ-1078-2016Under Investigation by firmADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Feb 4, 2016Class IIZ-1077-2016Under Investigation by firmADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Jan 27, 2015Class IIZ-1231-2015Process controlADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Jan 27, 2015Class IIZ-1230-2015Process controlADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Jan 27, 2015Class IIZ-1229-2015Process controlADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Sep 26, 2014Class IIZ-0164-2015Device DesignPositive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JLS devices

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

FDA decisions per year · JLS

FDA has decided no JLS device since 2007.

Median 510(k) review, days · JLS

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

Recalls per year · JLS

1in 2022

2008: 12010: 12018: 32021: 12022: 1
2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · JLS

3in 2025

2010: 12011: 12012: 62013: 192014: 12015: 12016: 62017: 92018: 12019: 72020: 42021: 412022: 172023: 182024: 72025: 3
2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JLS, 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—00
20080—10
20090—00
20100—11
20110—01
20120—06
20130—019
20140—01
20150—01
20160—06
20170—09
20180—31
20190—07
20200—04
20210—141
20220—117
20230—018
20240—07
20250—03
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 JLS

The JLS category page

  • K040923Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaIbl GmbH · 2004
  • K973898Progesterone ElisaKmi Diagnostics, Inc. · 1997
  • K972133Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070)Johnson & Johnson Clinical Diagnostics, Inc. · 1997
  • K971725Opus ProgesteroneBehring Diagnostics, Inc. · 1997
  • K964841Elecsys Progesterone AssayBoehringer Mannheim Corp. · 1997

https://510kreport.com/device/K932955 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932955: Ciba Corning Acs Progesterone Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932955

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026