Cleared Traditional

K871231 - ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B

K871231 is an FDA 510(k) clearance for ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B, manufactured by Microscan Div. Baxter Healthcare Corp.. The device is a Class 1 Microbiology device with product code GNX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K871231 · Microscan Div. Baxter Healthcare Corp. · Microbiology device
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Jun 1987
Decision
91d
Days
Class 1
Risk

K871231 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), 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 866.3330 - 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

FDA 510(k) Submission Details - K871231

510(k) Number K871231 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.

GNX Device Classification - Class 1, General Controls

Product Code GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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 - GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C

All 8
Devices cleared under the same product code (GNX) and FDA review panel - the closest regulatory comparables to K871231.
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
K901493 · Whittaker Bioproducts, Inc. · Jun 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · Whittaker Bioproducts, Inc. · Jan 1990
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · Baxter Diagnostics, Inc. · Nov 1988
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931 · Orion Diagnostica, Inc. · Jan 1981