Cleared Traditional

K990630 - SAS ADENO TEST

K990630 is an FDA 510(k) clearance for SAS ADENO TEST, manufactured by Sa Scientific, Inc.. The device is a Class 1 Microbiology device with product code GOD cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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.

View all Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K990630

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 102d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

GOD Device Classification - Class 1, General Controls

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.

Regulatory Peers - GOD Antigens, Cf (including Cf Control), Adenovirus 1-33

Devices cleared under the same product code (GOD) and FDA review panel - the closest regulatory comparables to K990630.
RPS ADENO DETECTOR PLUS
K110722 · Rapid Pathogen Screening, Inc. · May 2011
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc. · Dec 1997
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · Orion Diagnostica, Inc. · Jun 1987
ADENO VIRUS & CONTROLS
K802929 · Orion Diagnostica, Inc. · Dec 1980