Cleared Traditional

AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K920940) - FDA 510(k) Clearance

Class I Chemistry device.

K920940 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
50d
Days
Class 1
Risk

K920940 is an FDA 510(k) clearance for the AMERLITE FREE THYROID CONTROL SERA LAN.4002. 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 17, 1992 after a review of 50 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 K920940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date April 17, 1992
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 165
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K920940.
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927 · Helena Laboratories · Jun 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286 · Bio-Rad · Jun 1992
KEMTROL SERUM CONTROL-ABNORMAL
K920926 · Helena Laboratories · May 1992
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
K920826 · Eastman Kodak Company · Apr 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
K914255 · Bio-Rad · Jan 1992
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455 · Baxter Healthcare Corp · Aug 1991