Cleared Traditional

SAS ADENO TEST (K990630) - FDA 510(k) Clearance

Class I Microbiology device.

K990630 · Sa Scientific, Inc. · Microbiology device
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Aug 1999
Decision
174d
Days
Class 1
Risk

K990630 is an FDA 510(k) clearance for the SAS ADENO TEST. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 174 days - an extended review cycle.

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.

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Submission Details

510(k) Number K990630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1999
Decision Date August 19, 1999
Days to Decision 174 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
72d slower than avg
Panel avg: 102d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.