510(k) Report

510(k) · Cleared

Cleared

FSH Maiaclone Immunoradiometric Assay Kit

K862813510(k) TraditionalCleared Sep 16, 198654-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

Serono Diagnostics, Inc. · CGJ Radioimmunoassay, Follicle-Stimulating Hormone

Cleared on Sep 16, 1986 after a 54-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
Sep 16, 1986
Review
54 days
Class
Class I
Product code
CGJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK862813 FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK032002 Fertell Female Fertility TestGenosis, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK070484 Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K032002Fertell Female Fertility TestGenosis, Inc. · 2003 · cites it directly1descendant
  • K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862813FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc.1986—
+1K032002Fertell Female Fertility TestGenosis, Inc.2003—
+2K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
FIG. 1 — Lineage of K862813, 1986–2007Source: 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 CGJ? 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
K032002Fertell Female Fertility TestGenosis, Inc.20031

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, K032002 (Genosis, Inc., 2003) has gone furthest, with 1 descendant of its own.

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—

More from Serono Diagnostics, Inc.

25 FDA decisions under this applicant name. See the company

  • K953598Series 9100 Plus Automated Differential Hematology AnalyzersSerono Diagnostics, Inc. · 1996
  • K942051SR1 Dhea-S Enzyme ImmunoassaySerono Diagnostics, Inc. · 1994
  • K883085T3 Uptake Serozyme Enzyme Immuno KT/Mag Solid PhasSerono Diagnostics, Inc. · 1988
  • K882340LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaSerono Diagnostics, Inc. · 1988
  • K880388T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseSerono Diagnostics, Inc. · 1988

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/K862813 · printed Nov 5, 2026

Cite this page

510(k) Report. “K862813: FSH Maiaclone Immunoradiometric Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862813

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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