Cleared Traditional

MODEL 5500 CEAS (K934977) - FDA 510(k) Clearance

Class I Chemistry device.

K934977 · Esa, Inc. · Chemistry device
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Jan 1994
Decision
84d
Days
Class 1
Risk

K934977 is an FDA 510(k) clearance for the MODEL 5500 CEAS. Classified as Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (product code CDF), Class I - General Controls.

Submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1795 - 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 Esa, Inc. devices

Submission Details

510(k) Number K934977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date January 11, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDF Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1795
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 - CDF Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin

All 11
Devices cleared under the same product code (CDF) and FDA review panel - the closest regulatory comparables to K934977.
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
K953077 · Beckman Instruments, Inc. · Jan 1996
HVA & HOMOVANILLIC ACID BY HPLC METHOD
K873372 · Bio-Rad · Dec 1987
VMA BY HPLC TEST (VANILMANDELIC ACID)
K861010 · Bio-Rad · May 1986
HELENA VMA-SMC COLUMN METHOD
K810992 · Helena Laboratories · Apr 1981
VMA BY COLUMN TEST
K791837 · Bio-Rad · Oct 1979