Cleared Traditional

K920826 - HUMAN CHORIONIC GONADATROPHIN AND UNCON...

K920826 is the FDA 510(k) clearance for HUMAN CHORIONIC GONADATROPHIN AND UNCON... by Eastman Kodak Company. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K920826 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
43d
Days
Class 1
Risk

K920826 is an FDA 510(k) clearance for the HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 7, 1992 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Eastman Kodak Company devices

Submission Details

510(k) Number K920826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date April 07, 1992
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 474
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K920826.
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286 · Bio-Rad · Jun 1992
KEMTROL SERUM CONTROL-ABNORMAL
K920926 · Helena Laboratories · May 1992
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K920940 · Eastman Kodak Company · Apr 1992
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
K920350 · Streck Laboratories, Inc. · Mar 1992
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
K914204 · Medical Analysis Systems, Inc. · Mar 1992
N/T PROTEIN CONTROL UY
K914890 · Behring Diagnostics, Inc. · Feb 1992