Cleared Traditional

K905098 - ELEGANCE GH ELISA

K905098 is an FDA 510(k) clearance for ELEGANCE GH ELISA, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 1 Chemistry device with product code CFL cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K905098 · Bioclone Australia Pty , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
23d
Days
Class 1
Risk

K905098 is an FDA 510(k) clearance for the ELEGANCE GH ELISA. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on December 6, 1990 after a review of 23 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 Bioclone Australia Pty , Ltd. devices

FDA 510(k) Submission Details - K905098

510(k) Number K905098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date December 06, 1990
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 30
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K905098.
DELFIA(R) HGH KIT
K930484 · Wallac OY · May 1993
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · Medix Biotech, Inc. · Mar 1992
AIA-PACK HGH
K905757 · Tosoh Medics, Inc. · Jan 1991
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · Medix Biotech, Inc. · Dec 1989
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · Cyberfluor, Inc. · Aug 1988