Cleared Traditional

K870029 - IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (FDA 510(k) Clearance)

Class I Microbiology device.

K870029 · American Micro Scan · Microbiology device
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Mar 1987
Decision
79d
Days
Class 1
Risk

K870029 is an FDA 510(k) clearance for the IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE. Classified as Antisera, All Types, Streptococcus Pneumoniae (product code GWC), Class I - General Controls.

Submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: 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 American Micro Scan devices

Submission Details

510(k) Number K870029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1987
Decision Date March 25, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWC Antisera, All Types, Streptococcus Pneumoniae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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.