Cleared Traditional

K873082 - ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST

K873082 is an FDA 510(k) clearance for ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST, manufactured by Cambridge Bioscience Corp.. The device is a Class 1 Microbiology device with product code GOD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K873082 · Cambridge Bioscience Corp. · Microbiology device
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Feb 1988
Decision
203d
Days
Class 1
Risk

K873082 is an FDA 510(k) clearance for the ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Cambridge Bioscience Corp. (Worcester, US). The FDA issued a Cleared decision on February 24, 1988 after a review of 203 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3020 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cambridge Bioscience Corp. devices

FDA 510(k) Submission Details - K873082

510(k) Number K873082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1987
Decision Date February 24, 1988
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 102d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

GOD Device Classification - Class 1, General Controls

Product Code GOD Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3020
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 - GOD Antigens, Cf (including Cf Control), Adenovirus 1-33

Devices cleared under the same product code (GOD) and FDA review panel - the closest regulatory comparables to K873082.
RPS ADENO DETECTOR
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ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · Orion Diagnostica, Inc. · Jun 1987
ADENO VIRUS & CONTROLS
K802929 · Orion Diagnostica, Inc. · Dec 1980