510(k) Report

510(k) · Cleared

Cleared

Elecsys FSH Assay

K964693510(k) TraditionalCleared Dec 16, 199624-day reviewClass I21 CFR 862.1300

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

Boehringer Mannheim Corp. · CGJ Radioimmunoassay, Follicle-Stimulating Hormone

Cleared on Dec 16, 1996 as substantially equivalent to K900763 (Boehringer Mannheim Corp., 1990) after a 24-day review. Its family tree reaches back 1 generation to 1990.

Decided
Dec 16, 1996
Review
24 days
Class
Class I
Product code
CGJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K900763 (1990). No later device cites it as a predicate yet.

K900763 · Enzymun Test (R) FSH · Boehringer Mannheim Corp. · 199019901992199419961998
K900763 · Enzymun Test (R) FSH · Boehringer Mannheim Corp. · 19900
  1. Root · 1 generation backK900763 Enzymun Test (R) FSHBoehringer Mannheim Corp. · 1990
  2. This deviceK964693 Elecsys FSH AssayBoehringer Mannheim Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K900763Enzymun Test (R) FSHBoehringer Mannheim Corp.1990—
0 (this device)K964693Elecsys FSH AssayBoehringer Mannheim Corp.1996—
FIG. 1 — Lineage of K964693, 1990–1996Source: 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K900763Enzymun Test (R) FSH
Summary page 1
…n follicle stimulating hormone (FSH). Classification name: System, Test, Human Follicle Stimulating Hormone We claim substantial equivalence to the Enzymun® FSH Assay (K900763). Sandwich principle. Total duration of assay: 18 minutes. +1st incubation (9 min.): 40 pL of sample, a biotinylated monoclonal…
Boehringer Mannheim Corp.1990—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

How does its category compare?

All CGJ devices

CGJ Radioimmunoassay, Follicle-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGJ

FDA has decided no CGJ device since 2007.

Median 510(k) review, days · CGJ

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

Recalls per year · CGJ

1in 2023

2012: 12016: 12018: 12021: 12023: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · CGJ

4in 2025

2011: 12013: 12016: 12017: 22018: 12019: 12020: 32021: 22022: 12023: 32024: 32025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code CGJ, 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—00
20090—00
20100—00
20110—01
20120—10
20130—01
20140—00
20150—00
20160—11
20170—02
20180—11
20190—01
20200—03
20210—12
20220—01
20230—13
20240—03
20250—04
20260—0—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in CGJ

The CGJ category page

  • K052662One Step FSH Menopausal TestInd Diagnostic, Inc. · 20051 recall
  • K043599Moments Menopause Check, Model 9113Phamatech, Inc. · 2005
  • K041165FSH Menopause Predictor TestACON Laboratories, Inc. · 2004
  • K040575Pharmatech Menopause Check, Models 9111 and 9112Phamatech, Inc. · 2004
  • K030058Earlydetect Menopause Test for FSHEarly Detect, Inc. · 2003

https://510kreport.com/device/K964693 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964693: Elecsys FSH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964693

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026