Cleared Traditional

K102499 - DUOFERTILITY

K102499 · Cambridge Temperature Concepts , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
476d
Days
-
Risk

K102499 is an FDA 510(k) clearance for the DUOFERTILITY. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Cambridge Temperature Concepts , Ltd. (Cambridge, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K102499

510(k) Number K102499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2010
Decision Date December 20, 2011
Days to Decision 476 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 161d · This submission: 476d
Pathway characteristics
Predicate-based equivalence.

LHD Device Classification - Class 0,

Product Code LHD Device, Fertility Diagnostic, Proceptive
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT01343199 Completed Observational

Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application

30
Patients (actual)
1
Site
Condition studied Infertility
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Basil Matta
Sponsor Cambridge University Hospitals NHS Foundation Trust
Started 2011-03-01 → Primary completion 2014-05-01
Study completed - no results published. This trial concluded in 2014 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LHD Device, Fertility Diagnostic, Proceptive

All 18
Devices cleared under the same product code (LHD) and FDA review panel - the closest regulatory comparables to K102499.
Ava Fertility Tracker
K200163 · Ava AG · Jan 2021
OVUSENSE
K122337 · Fertility Focus, Ltd. · Aug 2013
LADY COMP USA
K050094 · Lady Comp USA · Apr 2006
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · Microlife Corp. · Sep 2003
PETIT SOPHIA
K021978 · Nishitomo Co., Inc. · Apr 2003
TCOYF FERTILITY SOFTWARE VERSION 1.0
K002726 · Ovusoft, LLC · Apr 2001
K102499 · DUOFERTILITY
Download PDF FDA Summary Cambridge Temperature…