Cleared Traditional

K972761 - SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY

K972761 is an FDA 510(k) clearance for SEALITE SCIENCES, manufactured by Sealite Sciences, Inc.. The device is a Class 1 Chemistry device with product code CFL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K972761 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
63d
Days
Class 1
Risk

K972761 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1370 - 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 - K972761

510(k) Number K972761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date September 25, 1997
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

CFL Device Classification - Class 1, General Controls

Product Code CFL Radioimmunoassay, Human Growth Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1370
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 - CFL Radioimmunoassay, Human Growth Hormone

All 29
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K972761.
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
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DSL 9100 IGF-II IRMA
K962758 · Diagnostic Systems Laboratories, Inc. · Aug 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
K961678 · Nichols Institute Diagnostics · Jul 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
K960551 · Diagnostic Systems Laboratories, Inc. · Mar 1996