Cleared Traditional

K941111 - STREP-SURE A/E

K941111 is an FDA 510(k) clearance for STREP-SURE A/E, manufactured by Clinical Standards Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K941111 · Clinical Standards Laboratories, Inc. · Microbiology device
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Aug 1994
Decision
148d
Days
Class 1
Risk

K941111 is an FDA 510(k) clearance for the STREP-SURE A/E. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Clinical Standards Laboratories, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Clinical Standards Laboratories, Inc. devices

FDA 510(k) Submission Details - K941111

510(k) Number K941111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date August 02, 1994
Days to Decision 148 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
46d slower than avg
Panel avg: 102d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 180
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BACTICARD STREP
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SERIM PYLORITEK REAGENT STRIPS
K936034 · Serim Research Corp. · Apr 1994