Cleared Traditional

K871228 - ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (FDA 510(k) Clearance)

Class I Microbiology device.

K871228 · Microscan Div. Baxter Healthcare Corp. · Microbiology device
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Jun 1987
Decision
91d
Days
Class 1
Risk

K871228 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2. Classified as Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (product code GQS), 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 866.3400 - 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 Microscan Div. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K871228 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.

Device Classification

Product Code GQS Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3400
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.