Cleared Traditional

K922870 - THREE SPIKE CUP (FDA 510(k) Clearance)

Class I Microbiology device.

K922870 · Osteo Technology, Inc. · Microbiology device
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Apr 1993
Decision
308d
Days
Class 1
Risk

K922870 is an FDA 510(k) clearance for the THREE SPIKE CUP. Classified as Antiserum, Cf, Rubeola (product code GRF), Class I - General Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - 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. Elevated predicate reliance profile. 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 Osteo Technology, Inc. devices

Submission Details

510(k) Number K922870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date April 08, 1993
Days to Decision 308 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRF Antiserum, Cf, Rubeola
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
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.