Cleared Traditional

K871229 - ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL

K871229 is an FDA 510(k) clearance for ANTIBODY ASSAY FOR DETECTION OF ADENOVI..., manufactured by Microscan Div. Baxter Healthcare Corp.. The device is a Class 1 Microbiology device with product code GOD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K871229 · Microscan Div. Baxter Healthcare Corp. · Microbiology device
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Jun 1987
Decision
91d
Days
Class 1
Risk

K871229 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on June 26, 1987 after a review of 91 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K871229

510(k) Number K871229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1987
Decision Date June 26, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 K871229.
RPS ADENO DETECTOR
K052092 · Rapid Pathogen Screening · Nov 2005
SAS ADENO TEST
K990630 · Sa Scientific, Inc. · Aug 1999
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K972406 · Immunoprobe, Inc. · Dec 1997
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · Orion Diagnostica, Inc. · Jun 1987
ADENO VIRUS & CONTROLS
K802929 · Orion Diagnostica, Inc. · Dec 1980
K871229 · ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
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