Cleared Traditional

K052662 - ONE STEP FSH MENOPAUSAL TEST

K052662 is an FDA 510(k) clearance for ONE STEP FSH MENOPAUSAL TEST, manufactured by Ind Diagnostic, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K052662 · Ind Diagnostic, Inc. · Chemistry device
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Nov 2005
Decision
64d
Days
Class 1
Risk

K052662 is an FDA 510(k) clearance for the ONE STEP FSH MENOPAUSAL TEST. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on November 30, 2005 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052662

510(k) Number K052662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date November 30, 2005
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 89d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 86
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K052662.
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599 · Phamatech, Inc. · Feb 2005
FSH MENOPAUSE PREDICTOR TEST
K041165 · ACON Laboratories, Inc. · Jun 2004
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
K040575 · Phamatech, Inc. · May 2004
EARLYDETECT MENOPAUSE TEST FOR FSH
K030058 · Early Detect, Inc. · Jul 2003
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · Genua 1944, Inc. · Jan 2001
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · Monobind · Sep 1997
K052662 · ONE STEP FSH MENOPAUSAL TEST
Download PDF Ind Diagnostic, Inc.