Cleared Traditional

K970085 - SEALITE SCIENCES AQUALITE FSH

K970085 is an FDA 510(k) clearance for SEALITE SCIENCES AQUALITE FSH, manufactured by Sealite Sciences, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K970085 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
35d
Days
Class 1
Risk

K970085 is an FDA 510(k) clearance for the SEALITE SCIENCES AQUALITE FSH. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 35 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.

View all Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K970085

510(k) Number K970085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date February 14, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 67
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K970085.
FSH MENOPAUSE PREDICTOR TEST
K041165 · ACON Laboratories, Inc. · Jun 2004
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · Monobind · Sep 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996
AMERLITE FSH ASSAY
K952285 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995