Cleared Traditional

K780388 - ANALYZER

K780388 is an FDA 510(k) clearance for ANALYZER, manufactured by Syva Co.. The device is a Class 1 Immunology device with product code JJE cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K780388 · Syva Co. · Immunology device
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Mar 1978
Decision
12d
Days
Class 1
Risk

K780388 is an FDA 510(k) clearance for the ANALYZER, 100, BICHROMATIC, ABBOTT. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1978 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2160 - the FDA immunology device 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 Syva Co. devices

FDA 510(k) Submission Details - K780388

510(k) Number K780388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1978
Decision Date March 22, 1978
Days to Decision 12 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 104d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 145
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K780388.
PRISMA
K791297 · Lkb Instruments, Inc. · Aug 1979
ANALYZER ABA-200
K782014 · Abbott Laboratories · Jan 1979
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · Coulter Electronics, Inc. · Sep 1978
MODEL 2/2 ANALYZER
K771245 · Eastman Kodak Company · Oct 1977
BICHROMATIC ANALYZER ABA-200
K771345 · Abbott Laboratories · Aug 1977
CHEMISTRY, COULTER
K770679 · Coulter Electronics, Inc. · May 1977