Cleared Traditional

K920505 - AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR

K920505 is an FDA 510(k) clearance for AMERLEX-M EXTENDED RANGE HUMAN CHORIONI..., manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K920505 · Eastman Kodak Company · Chemistry device
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Mar 1992
Decision
47d
Days
Class 2
Risk

K920505 is an FDA 510(k) clearance for the AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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.

FDA 510(k) Submission Details - K920505

510(k) Number K920505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date March 23, 1992
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 89d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K920505.
NOW PREGNANCY TEST KIT
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MIRCO ELISA HPL TEST KIT
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TMB CHROMOGEN/SUBSTRATE REAGENT SET
K920918 · Bio Clinic Co. · Apr 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · Medix Biotech, Inc. · Feb 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · Eastman Kodak Company · Jan 1992
PRECISE TM HCG
K915197 · Becton Dickinson Advanced Diagnostics · Dec 1991
K920505 · AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
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